Upstate Medical University

Clinical Trials

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Phase 2a Dengue Human Challenge Model (J2A)

Sponsored by Janssen Pharmaceuticals, Inc.

Background The purpose of this study is to evaluate an antiviral medication intended to treat Dengue virus, a disease that impacts thousands of people every year across the globe and has no current treatments. In order to determine the efficacy of the medication, participants will be infected with a weakened form of the Dengue virus, which will induce mild Dengue symptoms. This weakened form of this virus has been tested previously at Upstate, and our facility has experience managing the symptoms of patients who receive the mild form of this virus. 

Do I qualify? If you are a healthy adult between the ages of 18-55 who answers no to all of the following questions, you may be eligible to participate in this study.

  • Are you between the ages of 18-55 years old.
  • Have you had a liver or renal impairment?
  • Have you ever had an allergic reaction to shellfish, fetal bovine serum, L-glutamine, neomycin, streptomycin, or a previous vaccination?
  • Have you taken any investigation medications or vaccines in the past 6 months?
  • Are you currently enrolled or planning to enroll in an investigational trial within 90 days of completion of this trial?
  • Have you ever tested positive for HIV, Hepatitis B or C?
  • Have you ever tested positive for any flaviviruses, including DENV, Japanese encephalitis virus, West Nile virus, Yellow Fever virus, and/or Zika virus?
  • Have you ever traveled to a Yellow Fever virus region (Asia) or received a Yellow Fever vaccine?
  • Have you traveled to a region with DENV within the past 4 weeks, or have plans to travel to a DENV region during the course of this study?
  • Have you had any dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria in the last 5 years?
  • Have you donated or lost more than 1 unit (500 mL) of blood within the last 60 days?
  • Have you donated or are planning to donate more than 1 unit of plasma (250 mL) within 7 days before the start of the study?
  • Are you planning to donate any blood during the 6-month course of this study?
  • Are you currently using an CYP3A4 inhibitors?
  • Do you have any immunodeficiencies?
  • Are you taking any immunosuppressive drugs?
  • Have you had a significant alcohol or drug dependency within the last 12 months?
  • Do you have a BMI that is greater than 33?

If you have answered no to all of these questions, you may be eligible to participate in this study.

Time Commitment This study runs for 6 months. The study requires participants to appear for 31 clinical visits in the span of 35 days. Most of these visits will be approximately 2 hours in length. The two dosing visits, however, will be 15 hours in length. 

Interested? If you believe that you qualify for this study, contact us! We would be more than happy to answer your questions. We can be reached via phone at (315)-464-9869. You may also send us an email at trials@upstate.edu.

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ImmuneSense Lyme Study

Sponsored by Adaptive Biotechnologies Corporation

Background Adaptive Biotechnologies Corporation (Adaptive) has developed immunoSEQ Dx, an immunosequencing technology called immunoSEQ Dx which utilizes polymerase chain reaction (PCR) and next-generation sequencing (NGS) to identify and quantify rearranged T-cell receptor (TCR) gene sequences in a blood sample. When this is analyzed using the software algorithms, infections and disease can be detected based on their TCR sequence. Adaptive has developed immunoSEQ Dx to aid in the diagnosis of Lyme disease. The purpose of this study is to provide data that will aid in the validation for the immunoSEQ Dx Lyme assay. The researchers would also like to determine whether the technology can differentiate between active and resolve infections. Once approved, the assay will be used by healthcare professionals for clinical decision making.

Do I qualify? If you answer yes to any of the questions below, unfortunately, you are ineligible for the study. If you answer no to all of the questions, you may be eligible to participate.

  • Are you 6 years or younger?
  • Are you pregnant, mentally disabled, a prisoner, or a ward-of-the state?
  • Do you have any significant conditions, laboratory abnormalities, or psychiatric illnesses that would prevent you from safely participating in the study?
  • Have you been exposed to any investigational drugs in the past 60 days?
  • Have you donated more than one pint of blood in the past two months?
  • Have you ever received the Lyme disease vaccine?
  • Do you have any chronic infections, including HIV, tuberculosis, and Hepatitis B or C?
  • Do you have any active malignancies? 

Interested or have additional questions? Contact us! We can be reached via phone at (315)-464-9869. Or, you can send us an email at trials@upstate.edu. We look forward to hearing from you!

Sanofi Pasteur SA / Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to YF-VAX in Adults

Background:  The purpose of this study is to describe the safety and tolerability of a novel Yellow Fever vaccine.  Yellow Fever is a mosquito-borne disease that is caused by a virus that causes a wide range of health problems, from mild symptoms to severe illness.  Yellow Fever is a widespread in sub-Saharan Africa and tropical South America.  It continues to be a significant health problem for residents and non vaccinated travelers to these regions.  The vaccine is expected to help prevent Yellow Fever as their is no specific treatment for it.

 

Study Info and Commitment

  • Must be 18  and up to 60 on day of the screening.
  • May recieve the trial vaccine or currently approved YF-VAX
  • 10 visits over 5 year period.  Must be able to attend all visits, plus 1 screening visit for HIV testing if no evidence of a test within last 90 days.
  • Take and record your temperature and any symptoms every day, following 14 days after vaccination.
  • Blood samples will be collected each visit, except visit 3
  • Vaccine may cause headache, tiredness, injection site reaction, muscle pain, fever, stomach and joint pain

 

A PHASE 1 RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MODIFIED RNA VACCINE AGAINST INFLUENZA IN HEALTHY INDIVIDUALS

Background:  This will be a Phase 1 randomized study to evaluate the safety, tolerability and immunogenicity of a modified RNA vaccine against influenza in healthy individuals.

Inclusion Criteria,

  • Male or female particpates 65 to 85 years if age at visit 1 (Day 1)
  • Participates who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle conditions and other study procedures.
  • Healthy participants who are determined by medical history, physical examination and clinical judgment of the investigator to be eligible for the inclusion in the study.  Note: With the exception of heart disease, which is exclusionary, healthy participates with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.  Specific criteria for participate with known stable infection of HIV, HCV or HBV.
  • Capable of giving signed informed consent as described and compliance with requirements and restrictions listed in the ICD and in this protocol.

    Interested to learning more, click here to become a volunteer.

    Become a Volunteer >

CIVICs Influenza, SARS-CoV-2, and Other Respiratory Pathogen Screening Protocol for Future Challenge and Vaccination Studies

Background: A Registry of healthy adults who would potentially eligible for future vaccine studies.  Vaccine studies will be focused on respiratory viruses like COVID-19 and influenza.

Study Info and Commitment, A screening protocol to understand population immunity to respiratory viruses.  This study is recruiting healthy adults to gather vaccination history, history of recent infections, and collect blood at multiple time points to understand their immunity.  There will be potential recruitment into future studies, including: Influenza studies, SARS-CoV-2 studies and other respiratory infection or vaccine studies.  Involves visits every 6 months for up to 7 years (depending on enrollment in a study)

Interested to learning more, click here to become a volunteer.

Become a Volunteer >

A Low-Interventional Methodology Study to Obtain Biological Samples From Participants With Suspected Lyme Disease for the Purpose of Developing Clinical Diagnostic Assays

Background: The study’s primary objective is to collect a range of clinical specimens for suspected Lyme disease cases.  We will assess the implementation of specimen collection and diagnostic scheme for suspected lyme infection and or Lyme disease cases that may inform assay and clinical trail design.

Study Info and Commitment: 

  • Males and Females > 18 years of age with suspected Lyme disease.
  • Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study.
  • Participants who are willing and able to comply with scheduled visits and study procedures.

Interested to learning more, click here to become a volunteer.

Become a Volunteer >

 

Active Trials: Not Enrolling

Dengue Human Infection Model (DHIM-3)

Sponsored by SUNY Upstate Medical University

Title Phase One, Open Label Assessment of a Dengue-3-Virus-Live Virus Human Challenge 

Purpose The purpose of this study is to determine if we can develop this weakened dengue virus to safely produce mild dengue symptoms in a human. We want a weakened dengue virus so that in the future, we can use it to test whether or not new vaccines or drugs for dengue actially work. 

Background Dengue is a disease caused by a virus, which is transmitted by a mosquito. When a mosquito carrying dengue virus bites someone, that person can become sick with a dengue infection. These infections can be very mild, causing little to no symptoms, but often cause fevers, severe headaches, nausea, vomiting, muscle and joint pains, pain behind the eyes, and skin rash. This is characteristic of an uncomplicated dengue infection. However, in other, more severe cases, dengue infection can cause bleeding (hemorrhagic fever) and/or sudden decrease of blood pressure (shock). Severe reactions to natural dengue infection are uncommon and occur in less that 1% of all first infection cases. A severe infection from natural dengue can cause death in some cases, mostly in children. 

A Participant’s Role Participants will be injected with a weakened form of dengue virus type 3, in either a low, medium, or high dosage strength. While there are no treatments for dengue infection, supportive care will be provided if required that follows Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) guidelines. 

Qualification To be eligible for the study, you must:

  • Be at least 18 years old and no more than 45 years old at time of consent 
  • Be able to read, sign, and date informed consent
  • Provide consent for release of medical history records from PCPs, college or university, urgent care or emergency room visit 
  • Be in good health, as determined by medical history 
  • Have a negative urine screen for cocaine, amphetamines, or opiates 
  • Not plan to participate in another clinical trial in the 4 weeks before inoculation and for 6 months afterwards
  • Be willing to follow required procedures and protocols
  • Not have active diabetes or active peptic ulcer disease (PUD)
  • Not have chronic obstructive pulmonary disease (COPD) or coronary artery disease (CAD)
  • Not have a history of , or current, autoimmune disorder
  • Not have a history of Guillain-Barre syndrome (GBS)
  • Not have been diagnosed with bipolar disorder or schizophrenia, been hospitalized in the past year for a mental health disorder, or any other psychiatric condition which in the opinion of the investigator prevents the subject from participating in the study
  • Not have previously received a licensed or experimental flavivirus vaccine or had dengue or infection with any flavivirus that is related to dengue virus 
    • This includes West Nile virus, Yellow Fever virus, Japanese encephalitis virus, Zika virus, or any other flaviviruses and Hepatitis C virus
    • If you have lived or traveled to other countries, please inform the study doctor, so the study doctor can determine if any of these diseases occur in those areas
  • Have negative blood tests for the presence of antibodies to dengue, West Nile, and Zika virus
  • Have negative blood tests for HIV-1, Hepatitis B, Hepatitis C. A positive result must be reported to the local health department 
  • Not plan to be vaccinated for any flavivirus (travelers to some countries are often given Yellow Fever virus or Japanese encephalitis vaccines)
  • Not have traveled within the past 4 weeks to an area where dengue infections can occur naturally
  • Not have had a recent vaccination (within the past 4 weeks) and not planning to receive a vaccination with 4 weeks following inoculation
  • Not have had medicines or therapies (for example, radiation or chemotherapy) that suppress your immune system 
  • Not currently be taking anti-coagulant medication, non-steroidal anti-inflammatory drugs (NSAIDs) such as: Aspirin, Ibuprofen, Motrin, Naproxen, Advil, Aleve, Celebrex, or Nuprin
  • Not currently taking Methadone or Suboxone 
  • Not have had hives, shortness of breath, swelling of the lips or throat, or hospitalization related to a previous vaccination or have an allergy to specific medications/animals for which antigens may be in the virus preparations to include: shellfish, fetal bovine serum, L-glutamine, neomycin, and streptomycin 
  • Not have a history of chronic migraine heaches 
  • Not have a recent blood or blood product donation (56 days) and not planning to donate blood for 1 year after receiving the dengue infection 
  • Not planning to receive blood products or antibodies within 56 days of inoculation or during the study period (6 months)
  • Not have beliefs that prohibit the administration of blood products or transfusions

For females only: 

  • Non-pregnant or lactating 
  • Not be using an intrauterine device or intrauterine system, including Mirena, due to risk of heavy menstrual bleeding with these devices
  • Not have had heavy menstrual bleeding within the last 6 months (defined as periods lasting longer than 6 days, or requiring 5 or more pads or tampons per day)
  • Have no fibroids or uterine polyps, endometriosis, adenomyosis, or uterine scarring (e.g., after D&C)

Interested? Contact us today!

Personalized Antiplatelet Secondary Stroke Preventing (PASSPoRT)

Sponsored by

Background The purpose of this study is to establish the safety and feasibility of a personalized medicine approach that will be used to select a blood thinner that will be catered to each individual’s unique genetics and needs. This is important for doctors who care for patients with strokes and transient ischemic attacks (TIAs). The medicines that are used in this study are FDA approved.

Methods Patients will receive aspirin or clopidogrel for 21 days; following this, providers will select an antiplatelet medicine that they believe is best for the patient. The patient will be monitored for side effects and tolerance.

Do I qualify? If you answer yes to all of the questions below, you may be eligible to participate in the study.

  • Do you meet the criteria for a World Health Organization’s definition of a stroke, clinical stroke, or high-risk TIA?
  • Is the stroke mild or moderate in nature (National Institutes of Health Stroke Scale (NIHSS) score less than or equal to 14)?
  • Has it been less than 30 hours since the time of the stroke?

Exclusion Criteria Please click here for a list of questions. If you answer yes to any of the questions on the list, then you will not be able to participate in the study.

Interested? Please give us a call at (315)-464-9869 or email us at trials@upstate.edu

Convalescent Plasma Donation Treatment for COVID-19

Background The purpose of this study is to collect and assess plasma from people who have recovered from COVID-19 infection, as well as of those who have received plasma for treatment. Plasma, which is a component of blood, contains antibodies, which are the body’s natural defense against pathogens. Antibodies may play a crucial role in helping to fight COVID-19, especially in severely sick patients. In this study, plasma that is donated by volunteers will be used as an experimental treatment for patients who are currently ill with COVID-19. In addition, investigational assays will be used on samples to determine immune system reaction of plasma donors and recipients in response to COVID-19 infection. These samples may be used for other assays in the future. 

Do I qualify? If you have tested positive for COVID-19 and have been symptom-free for 14 days, you may be able to participate in this study.

Interested? Contact us! (315)-464-9869 or trials@upstate.edu

Interested to learning more, click here to become a volunteer.

Become a Volunteer >

 

SARS-CoV-2 RNA Vaccine

Sponsored by PfizeSponsored by Pfizer Inc. and BioNTechr Inc. and BioNTech

Purpose The purpose of this study is to evaluate the safety, tolerability and effectiveness of the vaccine in healthy adults.

Background After a new respiratory disease by the name of SARS-CoV-2 appeared in Wuhan, China, Pfizer and BioNTech partnered to develop a vaccine that would prevent COVID-19. Vaccines stimulate production of antibodies in your body to help you ward off disease. This research study involves 3 investigational vaccines to prevent COVID-19. The vaccines are all slightly different but work in the same way. The study will also test each of these vaccines at different dosages. These vaccines do not contain the whole virus, nor the parts of the virus that can make you ill; instead the vaccines contain components of the virus’s genetic code, surrounded by fatty particles called lipids. Using the protein-making machinery of your own cells, the genetic code will produce the spike protein that is seen on the outside of the virus. This spike protein will be recognized by the body as a threat, and antibodies against it will be produced that will then help the body fight against COVID-19. They use your own cells’ protein making machinery to produce some, or all, of the spike protein seen on the outside of the virus. This spike protein, made by your own body, may help your body to produce antibodies to fight against COVID-19. 

Qualifications In order to qualify for this study, you must meet the criteria listed below?

  • Must be 18-85yrs old and in good health (as determined by the investigator)
  • Must be willing and able to come in for all scheduled visits, and adhere to vaccination plan, lab tests and lifestyle considerations
  • Must complete e-diary for one week following vaccination
  • Must consent to being observed for 30 min after the vaccination
  • Must provide medical records and medical history at initial visit
  • Must consent to a urine pregnancy test for both visits
  • Must consent to a nasal swab for both visits
  • Must use an acceptable form of contraception for the duration of the study

Time Commitment The first vaccination will take place at the first visit. The second booster vaccination will take plays 19-23 days later, or 56-70 days later depending on the dose of the vaccine that you receive. After receiving both injections, you will be seen 2 weeks, 1 month, 6 months, 12 months, and 24 months after your second vaccine dose.

SAB-185

Title A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of SAB-185

Purpose To assess the safety of a new antibody intended to be used for COVID-19. 

Background Currently, there is an outbreak of respiratory disease caused by a novel coronavirus that was first detected in Wuhan City, Hubei Province, China, and that has now been detected in many locations internationally, including cases in the United States. The virus has been named “SARS‑CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID‑19) as noted in FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID‑19 Pandemic March 2020.There are currently no FDA-licensed treatment or prophylaxis options for COVID-19 and the related pneumonia caused by SARS-CoV-2. SAB-185 (Human polyclonal anti-SARS-CoV-2 antibody) is an option for treatment of COVID-19. SAB Biopharmaceuticals is conducting this study in collaboration with CSL Behring to study SAB‑185 to assess the safety of the treatment. The study will enroll a total of 28 healthy subjects (male and female) between 18-60 years of age.

Qualifications To be eligible for this study you must not have:

  • Known autoimmune condition requiring therapy more intensive than intermittent non-steroidal anti-inflammatories in the prior 6 months (for example: rheumatoid arthritis, lupus, inflammatory bowel disease)
  • Chronic respiratory disease COPD, emphysema, cystic fibrosis, pulmonary hypertension, or other chronic condition that requires the routine use of supplemental oxygen
  • Chronic asthma requiring the use of oral steroids or hospitalization in the last six months
  • Renal failure or renal insufficiency requiring dialysis
  • Congestive heart failure or significant atherosclerotic disease (coronary artery disease or peripheral vascular disease)
  • Hypertension
  • Diabetes
  • Currently vaping or smoking or history of chronic smoking
  • BMI >35
  • Any other underlying medical (cardiac, liver, renal, neurological, respiratory) or psychiatric condition that in the view of the investigator would preclude use of SAB-185
  • Known IgA deficiency or previous allergic reaction to intravenous immunoglobin (IVIG)/subcutaneous immunoglobin (SCIG)
  • Positive for hepatitis B virus, hepatitis C, or HIV
  • Ever screen positive for rheumatoid factor
  • History of COVID-19 or positive antibody or PCR (nasal test)
  • History of allergy, anaphylaxis, or severe reaction to beef products (including milk and gelatin)

HIV-1 Treatment for Virologically Suppressed Adults

Title A Phase III, randomized, multicenter, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus lamivudine in HIV-1 infected adults who are virologically suppressed

Purpose The purpose of this study is to determine the efficacy, safety and tolerability of two approved medicines, dolutegravir (DTG) plus lamivudine (3TC) taken together, compared with subjects taking their current tenofovir alafenamide (TAF)-based regimen (TBR) for the treatment of HIV-1 infected adults in whom the HIV-1 virus is currently suppressed. 

Background Recent data have shown that taking DTG + 3TC in combination is as effective over 1 year as a 3-drug regimen in participants newly initiating therapy. Since HIV medicines have to be taken life-long, it is very important to understand the long-term safety and tolerability of DTG + 3TC compared to TBR. The two-drug regimen of DTG and 3TC is considered experimental and is not yet approved for doctors to treat patients with HIV.  About 750 men and women in 10 countries will take part in this study.

Qualifications To be eligible for inclusion in this study, you must meet all of the following criteria:

  • Aged 18 years or older at the time of signing the informed consent
  • Proof of HIV-1 infection
  • Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to screening, one within 6-12 months and one 6 months prior to screening
  • Plasma HIV-1 RNA <50 c/mL at time of screening
  • Must be on uninterrupted ART for at least 6 months prior to screening
  • Male or female
  • Capable of giving signed informed consent

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

  • Women who are breastfeeding or plan to become pregnant or breastfeed during the study
  • Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease
  • Severe hepatic impairment
  • Unstable liver disease
  • Hepatitis B virus
  • Anticipated need for any hepatitis C virus therapy during the first 48 weeks of the study
  • Untreated syphilis infection
  • History or presence of allergy or intolerance to the study drugs, their components or drugs of their class
  • Ongoing malignancy
  • Subjects who, in the investigator’s judgment, poses a significant suicidality risk
  • Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening
  • Treatment with any of the following agents within 28 days of screening: radiation therapy, cytotoxic chemotherapeutic agents, systemic immune suppressants
  • Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP
  • Use of any regimen consisting of single or dual ART
  • Any evidence of major NRTI mutation or presence of any major INSTI resistance-associated mutation
  • Any verified Grade 4 laboratory abnormality
  • Any drug holiday during the 6 months prior to Screening
  • Any history of switch to another regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy

Effects of cART Long Term Exposure in HIV Infected Adults

Title Effects of cART Long-Term Exposure on Neuronal Function and Brain Microstructure in HIV Infected Individuals ART Naïve starting cART.

Purpose The purpose of this study is to determine what effects combination antiretroviral therapy (cART) has on brain function.

Background There are concerns that long-term exposure to combination antiretroviral therapy may predispose the brain to injury, especially in the older HIV infected subjects. The results from this study may provide further knowledge on how to best minimize the risks of brain injury due to HIV infection itself and those caused by the HIV drugs. This study will last for 2 years and have 5 visits to our office. Approximately 190 subjects will take part in this study. Subjects will be placed into one of three groups; HIV positive subjects starting antiretroviral treatment, HIV positive elite controllers, and HIV negative control subjects. Twenty subjects are expected to participate at Upstate Medical University.

Qualifications Potential study subjects need to fulfill the entry criteria below, according to group assignment:

  • 18 years of age or older
  • Able to provide informed consent
  • Able/willing to undergo neuropsychological and imaging testing
  • The following laboratory values within 60 days prior to baseline: Hemoglobin >9 gm/dL, Serum creatinine < 2 x ULN, AST, ALT, and alkaline phosphatase ≤2x ULN.
  • Negative serum or urine pregnancy test within 3 days prior to baseline if female of reproductive potential
  • Smoking and use of caffeinated drinks will be monitored and time from last use recorded. Subjects will be instructed to avoid smoking and use of caffeinated drinks for at least 2 hours prior to the scheduled imaging section.

Group 1 HIV+:

  • HIV-1 infection as documented by HIV test or 2 HIV-1RNA values> 2000 copies/mL at a CLIA certified lab.
  • ARV drug naive and willingness to begin antiretroviral therapy or have started ARV by no more than 2 weeks from study entry

Group 2 HIV-:

  • HIV negative test within 6 months of enrollment

Group 3 Elite Controllers:

  • HIV-1 infection as documented by HIV test at a CLIA certified lab., HIV-1RNA values <1000 copies/mL x ≥2 years; CD4 ≥ 400 at screening; no AIDS defining conditions.
  • No ARV treatment within the last year prior to screening

Volunteers will be excluded from participating if they are/have:

  • Unable to provide informed consent
  • Severe premorbid or comorbid psychiatric disorders.
  • Dementia (subjects that meet HIV-1-associated mild neurocognitive disorder or HIV-associated asymptomatic neurocognitive impairment will not be excluded)
  • Chronic seizures, stroke, head trauma resulting in loss of consciousness> 30 min, and multiple sclerosis
  • Brain infection, brain neoplasm, space-occupying brain lesions requiring acute or chronic therapy
  • Subjects with any fungal meningitis, toxoplasmosis, progressive multifocal leukoencephalopathy or CNS lymphoma are excluded from participation
  • Active alcohol and drug abuse or related medical complications within 6 months of study entry including but not limited to seizures, hallucinations, delirium tremens, or being in a detoxification program
  • Any significant systemic condition that that can alter brain function
  • Metallic implant, e.g., in skull, cardiac devices
  • Claustrophobia

Dengue Human Infection Model Expansion

Title Phase One, Open Label Expansion of a Dengue-1-Virus-Live Virus Human Challenge – (DENV-1-LVHC) Virus Strain

Purpose The purpose of this research study is to increase our understanding of how people respond to a low dose dengue virus injection. A weakened dengue virus is important so that, in the future, we can use it to test whether or not new vaccines or drugs for dengue actually work.

Background Dengue is a disease caused by a virus, transmitted by a certain mosquito. When a mosquito carrying the dengue virus bites someone, he or she can get sick with a dengue infection. These infections can be very mild, with little or no symptoms, but may cause fevers, severe headache, nausea, vomiting, muscle and joint pains, pain behind the eyes, and skin rash. This is referred to as an uncomplicated dengue infection. Occasionally the dengue infection can be severe and cause bleeding (hemorrhagic fever) and/or a sudden decrease of the blood pressure (shock). Severe reactions to natural dengue infections are uncommon and occur in less than 1% of all first infection cases. A severe infection from a natural dengue infection can cause death in some cases, mainly in children.

There are 4 types of dengue virus (1, 2, 3, and 4). Each one can make you sick. You usually cannot get sick from the same type twice. You can, however, get sick again if your second infection is with a different type of dengue. Second infections with a different type of dengue may have a more severe illness.

The types of mosquitoes that carry and transmit dengue virus are most frequently found in the tropical areas of the world (for example the Caribbean, South America, Asia, Puerto Rico, and Hawaii). They are present in some southeastern states in the United States (for example, Florida, Texas, Louisiana, Mississippi, Georgia). Except in rare instances, the mosquitoes present in the United States do not have the dengue virus. Therefore, there is a very low risk of contracting the disease in the continental United States compared to areas of the tropics where the disease is commonly present. While an outbreak of dengue occurred in Key West, Florida in 2009-2010, most dengue cases in US citizens are reported from people living in Puerto Rico, the US Virgin Islands, Samoa, and Guam or from travelers coming back from tropical areas. Dengue is now the leading cause of fever-causing illness in US travelers returning from the Caribbean, South America, and Asia.

This study involves injection with a weakened form of dengue virus type 1, using the lowest dosage used in DHIM-1. There are no specific treatments (antibiotic or antiviral medications) available for dengue infection, but other supportive care will be provided, if required. Supportive care may include: medication for management of pain, fever reducing drugs (acetaminophen), the management of fluid loss through oral or intravenous hydration, close monitoring and clinical assessment by a physician, and fluid replacement if required. This supportive care follows the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) guidelines.

Giving a controlled infection to test vaccines or to look at the immune system is done for a number of diseases, including malaria. It has been done with dengue viruses in the past. The weakened version of the dengue virus we are using in this study is newly produced, so now we need to carefully study the ways in which this new weakened dengue virus causes illness. We also want to ensure that it can safely cause a mild form of dengue illness that can be used in future research.

Dr. Stephen J. Thomas from SUNY Upstate Medical University is the principal investigator (PI), which means that he is responsible for conducting the study. This study will involve up to 9 adults. 

Qualifications To be eligible for this study you must:

  • Be at least 18 years old and no more than 45 years old at time of consent
  • At least 75% correct on test of your understanding of the information in this informed consent form
  • For females only, non-pregnant or non-lactating
  • Not be planning to become pregnant or father a child for the duration of the study (6 months) and using contraceptive methods to prevent pregnancy
  • Not be using an intrauterine device or intrauterine system, including Mirena®, due to risk of heavy menstrual bleeding with these devices
  • Not have had heavy menstrual bleeding within the last 6 months
  • Have no fibroids or uterine polyps, endometriosis, adenomyosis, or uterine scarring
  • Be in good health, as determined by medical history and physical examination
  • Provide consent for release of medical history records
  • Not have significant physical findings prior to inoculation
  • Not have active Diabetes or active peptic ulcer disease
  • Not have chronic obstructive pulmonary disease or coronary artery disease
  • Not have a history of, or current, auto-immune disease
  • Not have a history of Guillain-Barré syndrome
  • Not have been diagnosed with Bipolar Disorder or Schizophrenia, been hospitalized in the past year for a mental health disorder, or any other psychiatric condition, which in the opinion of the investigator prevents the subject from participating in the study
  • Not have previously received a licensed or experimental flavivirus vaccine or had dengue or infection with any flavivirus that is related to dengue virus.
  • Have negative blood tests for the presence of antibodies to dengue, West Nile, Yellow Fever, Japanese encephalitis and Zika virus
  • Have negative blood tests for HIV-1, Hepatitis B, and Hepatitis C
  • Not plan to be vaccinated for any flavivirus
  • Not have traveled within the past 4 weeks to an area where dengue infections occur naturally, and not have any planned travel during the study period (6 months)
  • Not plan to participate in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding inoculation, during the study period, or in the 6 months following inoculation
  • Not have had a recent vaccination (within the past 4 weeks) and not planning to receive a vaccination within 4 weeks following inoculation
  • Not have had medicines or therapies that suppress your immune system
  • Not currently be taking anti-coagulant medication, non-steroidal anti-inflammatory
  • Not currently taking Methadone or Suboxone
  • Not have had hives, shortness of breath, swelling of the lips or throat, or hospitalization related to a previous vaccination or have an allergy to specific medications/animals for which antigens may be in the virus preparations to include: Shellfish, Fetal Bovine Serum, L-Glutamine, Neomycin, and Streptomycin
  • Not have a history of chronic migraine headaches
  • Not have a recent blood donation (56 days) and not planning to donate blood for 1 year after receiving the dengue infection
  • Not planning to receive blood products or antibodies within 56 days of inoculation or during the study period
  • Have negative urine screen for cocaine, amphetamines, or opiates
  • Not have beliefs that prohibit the administration of blood products or transfusions
  • Be able to read, sign, and date this informed consent

HIV-1 Treatment using a Long Acting Single Agent

Title A Multicenter Study to Assess the Clinical Safety and Treatment Strategy of Using PRO 140 SC as Long-Acting Single-Agent Maintenance Therapy for 48 Weeks in Virologically Suppressed Subjects with CCR5-tropic HIV-1 Infection 

Purpose This study will help us to find out how safe and how well the study product, PRO 140 monotherapy, works in comparison to the combination of oral antiretroviral drugs for the maintenance of viral suppression in HIV-1 patients. 

Background The safety and effectiveness of PRO 140 has been previously evaluated in 174 people in previous studies. The product used in this study is an investigational drug. An investigational drug is one not approved by the U.S. Food and Drug Administration (FDA). The results of these studies will be used to design future studies to improve treatment of HIV-1 infection. About 500 subjects will enroll in the study across 60 centers within the USA. Approximately 10 subjects will enroll at SUNY Upstate Medical University.

Qualifications:

Potential subjects are required to meet all of the following criteria for enrollment into the study.

  • Receiving combination antiretroviral therapy for last 24 weeks
  • No change in antiretroviral regimen within last 4 weeks prior to Screening Visit and in-between Screening Visit and First Treatment Visit.
  • Subject has two or more potential alternative approved antiretroviral drug options to consider.
  • Documented Exclusive CCR5-tropic virus at Screening Visit as determined by Trofile? DNA Assay
  • Plasma HIV-1 RNA < 50 copies/mL at Screening Visit as determined by Human Immunodeficiency Virus 1 Quantitative, RNA (Taqman? Real-Time PCR)
  • No documented detectable viral loads within the last 24 weeks prior to Screening Visit
  • CD4 cell count of > 200 cells/mm3 since initiation of anti-retroviral therapy
  • CD4 cell count of > 350 cells/mm3 in preceding 24 weeks and at Screening Visit
  • Laboratory values at Screening that meet protocol criteria
  • Clinically normal resting 12-lead ECG at Screening Visit
  • Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception. Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug
  • Willing and able to participate in all aspects of the study

Potential subjects meeting any of the following criteria will be excluded from enrollment.

  • CXCR4-tropic virus or dual/mixed tropic virus determined by the Trofile? DNA Assay at the Screening Visit
  • Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen
  • Any active infection or malignancy requiring acute therapy
  • Laboratory test values ? grade 4 DAIDS laboratory abnormality.
  • Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
  • Unexplained fever or clinically significant illness within 1 week prior to the first study dose
  • Any vaccination within 2 weeks prior to the first study dose.
  • Subjects who have failed on a maraviroc containing regimen.
  • Subjects weighing < 35kg
  • History of anaphylaxis to any oral or parenteral drugs
  • History of Bleeding Disorder or patients on anti-coagulant therapy (except aspirin)
  • Participation in an experimental drug trial(s) within 30 days of the Screening Visit
  • Any known allergy or antibodies to the study drug or excipients
  • Treatment with any of the following:
  • Radiation or cytotoxic chemotherapy with 30 days prior to the screening visit
  • Immunosuppressants within 60 days prior to the screening visit
  • Immunomodulating agents, hydroxyurea, or foscarnet within 60 days prior to the screening visit
  • Oral or parenteral corticosteroids within 30 days prior to the Screening Visit. Subjects on chronic steroid therapy > 5 mg/day will be excluded with the following exception, subjects on inhaled, nasal, or topical steroids will not be excluded

Any other clinical condition that, in the Investigator’s judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

Recently Completed Trials

Specimen Acquisition for Viral Hepatitis

Title Specimen Acquisition for Viral Hepatitis – Analytical Collection Study

Purpose The purpose of this research study is to obtain blood samples that will be used to demonstrate the safety and effectiveness of several hepatitis and other infectious disease laboratory tests. 

Background This specimen acquisition study is being conducted to obtain blood samples from adult, pregnant and pediatric subjects that will be used to demonstrate the safety and effectiveness of several Roche hepatitis and/or other infectious disease tests over a period of several years. Clinical performance must be demonstrated for new tests to be approved by FDA for use by doctors. Samples will be collected from subjects according to the study protocol. The blood sample will be kept frozen and used for testing in several new assays to create the data required for FDA test approval.

About 2300 adult, 200 pregnant and 200 pediatric subjects will take part in this study collected over approximately 6 months at several different study sites. Your study doctor will enroll a share of the total subjects listed.  This study site will only enroll subjects 18 years of age or older.

Qualifications You might qualify if you meet any of the criteria below:

  • Recipient of blood transfusions before July 1992
  • Recipient of solid organ transplant before July 1992
  • Recipients of clotting factors before 1987 (hemophiliacs)
  • Recipient of blood or organs from a donor that was HCV-positive
  • Received long-term (chronic) hemodialysis treatments
  • HIV infected or immunocompromised
  • Persons born in countries with high rates of hepatitis (Africa, Asia and Pacific Islands)
  • Family history of any hepatitis
  • Children born to hepatitis-positive mothers
  • Have abnormal liver tests or liver disease
  • Tattoo artists
  • Health care worker after needle stick or exposure involving HCV-positive blood
  • Morticians
  • Commercial sex workers
  • IV drug users (current and past)
  • Individuals sharing straw cocaine
  • Individuals with tattoo or body piercing that was performed by non-licensed or nonprofessional facilities
  • Individuals with history of incarceration
  • Multiple sex partners (two or more partners in the past 12 months)
  • Engaging in sex with partner(s) with history of hepatitis
  • Engaging in sex with HIV-infected partner(s)
  • Diagnosed with STD’s (chlamydia, gonorrhea, herpes, syphilis, etc.)
  • Male-on-male sex partner(s)
  • Engaging in sex with commercial sex workers

Become a Volunteer >

Dengue Human Infection Model (DHIM-1)

Title Phase One, Open Label, Assessment of a Dengue-1-Virus- Live Virus Human Challenge (DENV-1-LVHC) Virus Strain

Purpose The purpose of this research study is to determine if we can develop this weakened dengue virus to safely produce mild dengue symptoms in a human. We want a weakened dengue virus so, in the future, we can use it to test whether or not new vaccines or drugs for dengue actually work. This study will last 6 months and have approximately 21 visits to our office.

Background Dengue is a disease caused by a virus that is transmitted by a mosquito. When someone is bitten by a mosquito carrying dengue virus, they can become sick with a dengue infection. These infections can be very mild, with little or no symptoms, but may cause fevers, severe headache, nausea, vomiting, muscle and joint pains, pain behind the eyes, and skin rash. This is referred to as an uncomplicated dengue infection. Occasionally the dengue infection can sometimes be severe and cause bleeding (hemorrhagic fever) and/or a sudden decrease of the blood pressure (shock). Severe reactions to natural dengue infections are uncommon and occur in less than 1% of all first infection cases. A severe infection from a natural dengue infection can cause death in some cases, mainly in children.

There are 4 types of dengue virus (1, 2, 3, and 4). Each one can make you sick. You usually cannot get sick from the same type twice. You can, however, get sick again if your second infection is with a different type of dengue. Second infections with a different type of dengue may have a more severe illness.

This study involves injection with a weakened form of dengue virus type 1 using 1 of 3 possible dosage strengths (low, medium, or high). There are no specific treatments (antibiotic or antiviral medications) available for dengue infection, but other supportive care will be provided, if required. Supportive care may include: medication for management of pain, fever reducing drugs (acetaminophen), the management of fluid loss through oral or intravenous hydration, close monitoring and clinical assessment by a physician, and fluid replacement if required. This supportive care follows the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) guidelines.

The types of mosquitoes that carry and transmit dengue virus are most frequently found in the tropical areas of the world (for example the Caribbean, South America, Asia, Puerto Rico, and Hawaii). They are present in some southeastern states in the United States (for example, Florida, Texas, Louisiana, Mississippi, Georgia). But except in rare instances, the mosquitoes present in the United States do not have the dengue virus. Therefore, there is a very low risk of contracting the disease in the continental United States compared to areas of the tropics where the disease is commonly present. While an outbreak of dengue occurred in Key West, Florida in 2009-2010, most dengue cases in US citizens are reported from people living in Puerto Rico, the US Virgin Islands, Samoa, and Guam or from travelers coming back from tropical areas. Dengue is now the leading cause of fever-causing illness in US travelers returning from the Caribbean, South America, and Asia.

Similar dengue studies have been done in humans before, using several different weakened dengue viruses. Some of these studies involve people who have been given investigational vaccinations against dengue fever prior to a weakened virus challenge, and some include people who were not vaccinated, but were just given the virus. Most subjects from these previous studies became ill with dengue fever, but some subjects did not become ill. The virus being used in this study is closely related to a version that has been used previously in 11 subjects. All of the previous subjects recovered within 30 days and showed no signs of long-term illness from participation in the study. We cannot guarantee this same recovery period or lack of long-term effects if you decide to participate in this study.

Giving a controlled infection to test vaccines or to look at the immune system is done for a number of diseases including malaria. It has been done with dengue viruses in the past. The weakened version of the dengue virus we are using in this study is newly produced, so now we need to carefully study the ways in which this new weakened dengue virus causes illness.

While there have been other dengue infection trials, including with this type of dengue, this is the first study to use this particular weakened dengue virus in humans. We expect that subjects in this study will get a dengue infection, and this infection may require hospitalization.

We plan to enroll up to 27 subjects in the study. The subjects will be divided into 3 groups who will receive 1 of 3 different doses of the virus, beginning with the lowest dose. If safety issues are found with 1 of the doses, the higher doses will not be given.

Qualifications To be eligible for this study you must:

  • Be at least 18 years old and no more than 45 years old at time of consent
  • At least 75% correct on test of your understanding of the information in this informed consent form
  • For females only, non-pregnant or non-lactating
  • Not be planning to become pregnant or father a child for the duration of the study (6 months) and using contraceptive methods to prevent pregnancy
  • Not be using an intrauterine device or intrauterine system, including Mirena?, due to risk of heavy menstrual bleeding with these devices
  • Not have had heavy menstrual bleeding within the last 6 months
  • Have no fibroids or uterine polyps, endometriosis, adenomyosis, or uterine scarring
  • Be in good health, as determined by medical history and physical examination
  • Provide consent for release of medical history records
  • Not have abnormal lab results or significant physical findings prior to inoculation
  • Not have active Diabetes or active peptic ulcer disease
  • Not have chronic obstructive pulmonary disease or coronary artery disease
  • Not have a history of, or current, auto-immune disease
  • Not have a history of Guillain-Barr? syndrome
  • Not have been diagnosed with Bipolar Disorder or Schizophrenia, been hospitalized in the past year for a mental health disorder, or any other psychiatric condition, which in the opinion of the investigator prevents the subject from participating in the study
  • Not have previously received a licensed or experimental flavivirus vaccine or had dengue or infection with any flavivirus that is related to dengue virus.
  • Have negative blood tests for seroconversion to dengue, West Nile, Yellow Fever, Japanese encephalitis and Zika virus
  • Have negative blood tests for HIV-1, Hepatitis B, and Hepatitis C
  • Not plan to be vaccinated for any flavivirus
  • Not have traveled within the past 4 weeks to an area where dengue infections occur naturally, and not have any planned travel during the study period (6 months)
  • Not plan to participate in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding inoculation, during the study period, or in the 6 months following inoculation
  • Not have had a recent vaccination (within the past 4 weeks) and not planning to receive a vaccination within 4 weeks following inoculation
  • Not have had medicines or therapies that suppress your immune system
  • Not currently be taking anti-coagulant medication, non-steroidal anti-inflammatory drugs
  • Not currently taking Methadone or Suboxone
  • Not have had hives, shortness of breath, swelling of the lips or throat, or hospitalization related to a previous vaccination or have an allergy to specific medications/animals for which antigens may be in the virus preparations to include: Shellfish, Fetal Bovine Serum, L-Glutamine, Neomycin, and Streptomycin
  • Not have a history of chronic migraine headaches
  • Not have a recent blood donation (56 days) and not planning to donate blood for 1 year after receiving the dengue infection
  • Not planning to receive blood products or antibodies within 56 days of inoculation or during the study period (6 months)
  • Have negative urine screen for cocaine, amphetamines, or opiates
  • Not have beliefs that prohibit the administration of blood products or transfusions
  • Be able to read, sign, and date this informed consent

HIV Treatment for Treatment-Experienced Adults

Title A Multicenter, Randomized, Double-blind, Placebo-controlled Trial, Followed by Single-Arm Treatment of PRO 140 in Combination With Optimized Background Therapy in Treatment-Experienced HIV-1 Subjects.

<!– wp:carbon-fields/accordion {“data”:{“crb_accordion”:[{“_id”:”cf-Ijss0qgpTiXJHLQJo8BOF”,”_type”:”_”,”category”:[“healthy-volunteer”,”infection-model”],”big_title”:”Active Clinical Trials: Now Enrolling”,”tag”:”Now Enrolling – Volunteer for Trial \u0026raquo;“,”title”:”Phase 2a Dengue Human Challenge Model (J2A)”,”subtitle”:”Sponsored by Janssen Pharmaceuticals, Inc.”,”text”:”\u003cp\u003e\u003cstrong\u003eBackground \u003c/strong\u003eThe purpose of this study is to evaluate an antiviral medication intended to treat Dengue virus, a disease that impacts thousands of people every year across the globe and has no current treatments. In order to determine the efficacy of the medication, participants will be infected with a weakened form of the Dengue virus, which will induce mild Dengue symptoms. This weakened form of this virus has been tested previously at Upstate, and our facility has experience managing the symptoms of patients who receive the mild form of this virus. \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDo I qualify?\u003c/strong\u003e If you are a healthy adult between the ages of 18-50 who answers no to all of the following questions, you may be eligible to participate in this study.\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eAre you younger than 18 or older than 50 years old?\u003c/li\u003e\n\u003cli\u003eAre you currently taking any medications with the exception of Tylenol and/or hormone replacement therapy?\u003c/li\u003e\n\u003cli\u003eHave you had a liver or renal impairment?\u003c/li\u003e\n\u003cli\u003eHave you ever had an allergic reaction to shellfish, fetal bovine serum, L-glutamine, neomycin, streptomycin, or a previous vaccination?\u003c/li\u003e\n\u003cli\u003eHave you taken any investigation medications or vaccines in the past 6 months?\u003c/li\u003e\n\u003cli\u003eAre you currently enrolled or planning to enroll in an investigational trial within 90 days of completion of this trial?\u003c/li\u003e\n\u003cli\u003eHave you ever tested positive for HIV, Hepatitis B or C?\u003c/li\u003e\n\u003cli\u003eHave you ever tested positive for any flaviviruses, including DENV, Japanese encephalitis virus, West Nile virus, Yellow Fever virus, and/or Zika virus?\u003c/li\u003e\n\u003cli\u003eHave you ever traveled to a Yellow Fever virus region (Asia) or received a Yellow Fever vaccine?\u003c/li\u003e\n\u003cli\u003eHave you traveled to a region with DENV within the past 4 weeks, or have plans to travel to a DENV region during the course of this study?\u003c/li\u003e\n\u003cli\u003eHave you received or plan to receive any vaccines 14 days prior to the start of this study?\u003c/li\u003e\n\u003cli\u003eHave you had any dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria in the last 5 years?\u003c/li\u003e\n\u003cli\u003eHave you donated or lost more than 1 unit (500 mL) of blood within the last 60 days?\u003c/li\u003e\n\u003cli\u003eHave you donated or are planning to donate more than 1 unit of plasma (250 mL) within 7 days before the start of the study?\u003c/li\u003e\n\u003cli\u003eAre you planning to donate any blood during the 6-month course of this study?\u003c/li\u003e\n\u003cli\u003eAre you currently using an CYP3A4 inhibitors?\u003c/li\u003e\n\u003cli\u003eDo you have any immunodeficiencies?\u003c/li\u003e\n\u003cli\u003eAre you taking any immunosuppressive drugs?\u003c/li\u003e\n\u003cli\u003eHave you had a significant alcohol or drug dependency within the last 12 months?\u003c/li\u003e\n\u003cli\u003eDo you have a BMI that is greater than 30?\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eIf you have answered no to all of these questions, you may be eligible to participate in this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTime Commitment\u003c/strong\u003e This study runs for 6 months. The study requires participants to appear for 31 clinical visits in the span of 35 days. Most of these visits will be approximately 2 hours in length. The two dosing visits, however, will be 15 hours in length. \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterested? \u003c/strong\u003eIf you believe that you qualify for this study, contact us! We would be more than happy to answer your questions. We can be reached via phone at (315)-464-9869. You may also send us an email at trials@upstate.edu.\u003c/p\u003e\n\u003cp\u003ehttps://upstateglobalhealth.org/clinical-trials/volunteers/become-a-volunteer/\u003c/p\u003e”},{“_id”:”cf-0uR34ZBXMnamhP5M7yKSQ”,”_type”:”_”,”category”:[“diagnostic”],”big_title”:””,”tag”:””,”title”:”ImmuneSense Lyme Study”,”subtitle”:”Sponsored by Adaptive Biotechnologies Corporation “,”text”:”\u003cp\u003e\u003cstrong\u003eBackground \u003c/strong\u003eAdaptive Biotechnologies Corporation (Adaptive) has developed immunoSEQ Dx, an immunosequencing technology called immunoSEQ Dx which utilizes polymerase chain reaction (PCR) and next-generation sequencing (NGS) to identify and quantify rearranged T-cell receptor (TCR) gene sequences in a blood sample. When this is analyzed using the software algorithms, infections and disease can be detected based on their TCR sequence. Adaptive has developed immunoSEQ Dx to aid in the diagnosis of Lyme disease. The purpose of this study is to provide data that will aid in the validation for the immunoSEQ Dx Lyme assay. The researchers would also like to determine whether the technology can differentiate between active and resolve infections. Once approved, the assay will be used by healthcare professionals for clinical decision making.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDo I qualify? \u003c/strong\u003eIf you answer yes to any of the questions below, unfortunately, you are ineligible for the study. If you answer no to all of the questions, you may be eligible to participate.\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eAre you 6 years or younger?\u003c/li\u003e\n\u003cli\u003eAre you pregnant, mentally disabled, a prisoner, or a ward-of-the state?\u003c/li\u003e\n\u003cli\u003eDo you have any significant conditions, laboratory abnormalities, or psychiatric illnesses that would prevent you from safely participating in the study?\u003c/li\u003e\n\u003cli\u003eHave you been exposed to any investigational drugs in the past 60 days?\u003c/li\u003e\n\u003cli\u003eHave you donated more than one pint of blood in the past two months?\u003c/li\u003e\n\u003cli\u003eHave you ever received the Lyme disease vaccine?\u003c/li\u003e\n\u003cli\u003eDo you have any chronic infections, including HIV, tuberculosis, and Hepatitis B or C?\u003c/li\u003e\n\u003cli\u003eDo you have any active malignancies? \u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eInterested or have additional questions? \u003c/strong\u003eContact us! We can be reached via phone at (315)-464-9869. Or, you can send us an email at trials@upstate.edu. We look forward to hearing from you!\u003c/p\u003e”},{“_id”:”cf-72B9LTbZeHaBGb_k0rkV5″,”_type”:”_”,”category”:[“vaccine”,”healthy-volunteer”],”big_title”:””,”tag”:””,”title”:”Sanofi Pasteur SA / Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to YF-VAX in Adults”,”subtitle”:””,”text”:”\u003cp\u003e\u003cb\u003eBackground:  \u003c/b\u003eThe purpose of this study is to describe the safety and tolerability of a novel Yellow Fever vaccine.  Yellow Fever is a mosquito-borne disease that is caused by a virus that causes a wide range of health problems, from mild symptoms to severe illness.  Yellow Fever is a widespread in sub-Saharan Africa and tropical South America.  It continues to be a significant health problem for residents and non vaccinated travelers to these regions.  The vaccine is expected to help prevent Yellow Fever as their is no specific treatment for it.\u003c/p\u003e\n\u003cp\u003e \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy Info and Commitment\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eMust be 18  and up to 60 on day of the screening.\u003c/li\u003e\n\u003cli\u003eMay recieve the trial vaccine or currently approved YF-VAX\u003c/li\u003e\n\u003cli\u003e10 visits over 5 year period.  Must be able to attend all visits, plus 1 screening visit for HIV testing if no evidence of a test within last 90 days.\u003c/li\u003e\n\u003cli\u003eTake and record your temperature and any symptoms every day, following 14 days after vaccination.\u003c/li\u003e\n\u003cli\u003eBlood samples will be collected each visit, except visit 3\u003c/li\u003e\n\u003cli\u003eVaccine may cause headache, tiredness, injection site reaction, muscle pain, fever, stomach and joint pain\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e \u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003eInterested to learning more, click here to become a volunteer.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003ca href=\u0022https://upstateglobalhealth.org/clinical-trials/volunteers/become-a-volunteer/\u0022\u003e\u003cstrong\u003eBecome a Volunteer \u0026gt;\u003c/strong\u003e\u003c/a\u003e\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e”},{“_id”:”cf-JJ2g1d5vg_lp4DNglLdeD”,”_type”:”_”,”category”:[“vaccine”,”healthy-volunteer”],”big_title”:””,”tag”:””,”title”:”A PHASE 1 RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MODIFIED RNA VACCINE AGAINST INFLUENZA IN HEALTHY INDIVIDUALS”,”subtitle”:””,”text”:”\u003cp\u003e\u003cb\u003eBackground: \u003c/b\u003e This will be a Phase 1 randomized study to evaluate the safety, tolerability and immunogenicity of a modified RNA vaccine against influenza in healthy individuals.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInclusion Criteria,\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eMale or female particpates 65 to 85 years if age at visit 1 (Day 1)\u003c/li\u003e\n\u003cli\u003eParticipates who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle conditions and other study procedures.\u003c/li\u003e\n\u003cli\u003eHealthy participants who are determined by medical history, physical examination and clinical judgment of the investigator to be eligible for the inclusion in the study.  Note: With the exception of heart disease, which is exclusionary, healthy participates with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.  Specific criteria for participate with known stable infection of HIV, HCV or HBV.\u003c/li\u003e\n\u003cli\u003eCapable of giving signed informed consent as described and compliance with requirements and restrictions listed in the ICD and in this protocol.\n\u003cp\u003e\u003cstrong\u003eInterested to learning more, click here to become a volunteer.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003ca href=\u0022https://upstateglobalhealth.org/clinical-trials/volunteers/become-a-volunteer/\u0022\u003e\u003cstrong\u003eBecome a Volunteer \u0026gt;\u003c/strong\u003e\u003c/a\u003e\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e”},{“_id”:”cf-FF6KGRGDN3DLC3lJJYJXG”,”_type”:”_”,”category”:[“healthy-volunteer”],”big_title”:””,”tag”:””,”title”:”CIVICs Influenza, SARS-CoV-2, and Other Respiratory Pathogen Screening Protocol for Future Challenge and Vaccination Studies”,”subtitle”:””,”text”:”\u003cp\u003e\u003cb\u003eBackground:\u003c/b\u003e A Registry of healthy adults who would potentially eligible for future vaccine studies.  Vaccine studies will be focused on respiratory viruses like COVID-19 and influenza.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy Info and Commitment, \u003c/strong\u003eA screening protocol to understand population immunity to respiratory viruses.  This study is recruiting healthy adults to gather vaccination history, history of recent infections, and collect blood at multiple time points to understand their immunity.  There will be potential recruitment into future studies, including: Influenza studies, SARS-CoV-2 studies and other respiratory infection or vaccine studies.  Involves visits every 6 months for up to 7 years (depending on enrollment in a study)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterested to learning more, click here to become a volunteer.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003ca href=\u0022https://upstateglobalhealth.org/clinical-trials/volunteers/become-a-volunteer/\u0022\u003e\u003cstrong\u003eBecome a Volunteer \u0026gt;\u003c/strong\u003e\u003c/a\u003e\u003c/p\u003e”},{“_id”:”cf-O_S79VqR5tex2GZDVXo4r”,”_type”:”_”,”category”:[“healthy-volunteer”],”big_title”:””,”tag”:””,”title”:”A Low-Interventional Methodology Study to Obtain Biological Samples From Participants With Suspected Lyme Disease for the Purpose of Developing Clinical Diagnostic Assays”,”subtitle”:””,”text”:”\u003cp\u003e\u003cb\u003eBackground: \u003c/b\u003eThe study’s primary objective is to collect a range of clinical specimens for suspected Lyme disease cases.  We will assess the implementation of specimen collection and diagnostic scheme for suspected lyme infection and or Lyme disease cases that may inform assay and clinical trail design.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy Info and Commitment: \u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eMales and Females \u0026gt; 18 years of age with suspected Lyme disease.\u003c/li\u003e\n\u003cli\u003eEvidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study.\u003c/li\u003e\n\u003cli\u003eParticipants who are willing and able to comply with scheduled visits and study procedures.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eInterested to learning more, click here to become a volunteer.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003ca href=\u0022https://upstateglobalhealth.org/clinical-trials/volunteers/become-a-volunteer/\u0022\u003e\u003cstrong\u003eBecome a Volunteer \u0026gt;\u003c/strong\u003e\u003c/a\u003e\u003c/p\u003e\n\u003cp\u003e \u003c/p\u003e”},{“_id”:”cf-YMONWMeVFoext4l69bugh”,”_type”:”_”,”category”:[“treatment”],”big_title”:”Active Trials: Not Enrolling”,”tag”:””,”title”:”Dengue Human Infection Model (DHIM-3)”,”subtitle”:”Sponsored by SUNY Upstate Medical University”,”text”:”\u003cp\u003e\u003cstrong\u003eTitle \u003c/strong\u003ePhase One, Open Label Assessment of a Dengue-3-Virus-Live Virus Human Challenge \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePurpose \u003c/strong\u003eThe purpose of this study is to determine if we can develop this weakened dengue virus to safely produce mild dengue symptoms in a human. We want a weakened dengue virus so that in the future, we can use it to test whether or not new vaccines or drugs for dengue actially work. \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBackground \u003c/strong\u003eDengue is a disease caused by a virus, which is transmitted by a mosquito. When a mosquito carrying dengue virus bites someone, that person can become sick with a dengue infection. These infections can be very mild, causing little to no symptoms, but often cause fevers, severe headaches, nausea, vomiting, muscle and joint pains, pain behind the eyes, and skin rash. This is characteristic of an uncomplicated dengue infection. However, in other, more severe cases, dengue infection can cause bleeding (hemorrhagic fever) and/or sudden decrease of blood pressure (shock). Severe reactions to natural dengue infection are uncommon and occur in less that 1% of all first infection cases. A severe infection from natural dengue can cause death in some cases, mostly in children. \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eA Participant’s Role \u003c/strong\u003eParticipants will be injected with a weakened form of dengue virus type 3, in either a low, medium, or high dosage strength. While there are no treatments for dengue infection, supportive care will be provided if required that follows Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) guidelines. \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQualification \u003c/strong\u003eTo be eligible for the study, you must:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eBe at least 18 years old and no more than 45 years old at time of consent \u003c/li\u003e\n\u003cli\u003eBe able to read, sign, and date informed consent\u003c/li\u003e\n\u003cli\u003eProvide consent for release of medical history records from PCPs, college or university, urgent care or emergency room visit \u003c/li\u003e\n\u003cli\u003eBe in good health, as determined by medical history \u003c/li\u003e\n\u003cli\u003eHave a negative urine screen for cocaine, amphetamines, or opiates \u003c/li\u003e\n\u003cli\u003eNot plan to participate in another clinical trial in the 4 weeks before inoculation and for 6 months afterwards\u003c/li\u003e\n\u003cli\u003eBe willing to follow required procedures and protocols\u003c/li\u003e\n\u003cli\u003eNot have active diabetes or active peptic ulcer disease (PUD)\u003c/li\u003e\n\u003cli\u003eNot have chronic obstructive pulmonary disease (COPD) or coronary artery disease (CAD)\u003c/li\u003e\n\u003cli\u003eNot have a history of , or current, autoimmune disorder\u003c/li\u003e\n\u003cli\u003eNot have a history of Guillain-Barre syndrome (GBS)\u003c/li\u003e\n\u003cli\u003eNot have been diagnosed with bipolar disorder or schizophrenia, been hospitalized in the past year for a mental health disorder, or any other psychiatric condition which in the opinion of the investigator prevents the subject from participating in the study\u003c/li\u003e\n\u003cli\u003eNot have previously received a licensed or experimental flavivirus vaccine or had dengue or infection with any flavivirus that is related to dengue virus \n\u003cul\u003e\n\u003cli\u003eThis includes West Nile virus, Yellow Fever virus, Japanese encephalitis virus, Zika virus, or any other flaviviruses and Hepatitis C virus\u003c/li\u003e\n\u003cli\u003eIf you have lived or traveled to other countries, please inform the study doctor, so the study doctor can determine if any of these diseases occur in those areas\u003c/li\u003e\n\u003c/ul\u003e\n\u003c/li\u003e\n\u003cli\u003eHave negative blood tests for the presence of antibodies to dengue, West Nile, and Zika virus\u003c/li\u003e\n\u003cli\u003eHave negative blood tests for HIV-1, Hepatitis B, Hepatitis C. A positive result must be reported to the local health department \u003c/li\u003e\n\u003cli\u003eNot plan to be vaccinated for any flavivirus (travelers to some countries are often given Yellow Fever virus or Japanese encephalitis vaccines)\u003c/li\u003e\n\u003cli\u003eNot have traveled within the past 4 weeks to an area where dengue infections can occur naturally\u003c/li\u003e\n\u003cli\u003eNot have had a recent vaccination (within the past 4 weeks) and not planning to receive a vaccination with 4 weeks following inoculation\u003c/li\u003e\n\u003cli\u003eNot have had medicines or therapies (for example, radiation or chemotherapy) that suppress your immune system \u003c/li\u003e\n\u003cli\u003eNot currently be taking anti-coagulant medication, non-steroidal anti-inflammatory drugs (NSAIDs) such as: Aspirin, Ibuprofen, Motrin, Naproxen, Advil, Aleve, Celebrex, or Nuprin\u003c/li\u003e\n\u003cli\u003eNot currently taking Methadone or Suboxone \u003c/li\u003e\n\u003cli\u003eNot have had hives, shortness of breath, swelling of the lips or throat, or hospitalization related to a previous vaccination or have an allergy to specific medications/animals for which antigens may be in the virus preparations to include: shellfish, fetal bovine serum, L-glutamine, neomycin, and streptomycin \u003c/li\u003e\n\u003cli\u003eNot have a history of chronic migraine heaches \u003c/li\u003e\n\u003cli\u003eNot have a recent blood or blood product donation (56 days) and not planning to donate blood for 1 year after receiving the dengue infection \u003c/li\u003e\n\u003cli\u003eNot planning to receive blood products or antibodies within 56 days of inoculation or during the study period (6 months)\u003c/li\u003e\n\u003cli\u003eNot have beliefs that prohibit the administration of blood products or transfusions\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eFor females only: \u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eNon-pregnant or lactating \u003c/li\u003e\n\u003cli\u003eNot be using an intrauterine device or intrauterine system, including Mirena, due to risk of heavy menstrual bleeding with these devices\u003c/li\u003e\n\u003cli\u003eNot have had heavy menstrual bleeding within the last 6 months (defined as periods lasting longer than 6 days, or requiring 5 or more pads or tampons per day)\u003c/li\u003e\n\u003cli\u003eHave no fibroids or uterine polyps, endometriosis, adenomyosis, or uterine scarring (e.g., after D\u0026amp;C)\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eInterested?\u003c/strong\u003e Contact us today!\u003c/p\u003e”},{“_id”:”cf-jbRxjS43gjkqZR_E4feeG”,”_type”:”_”,”category”:[“treatment”],”big_title”:””,”tag”:””,”title”:”Personalized Antiplatelet Secondary Stroke Preventing (PASSPoRT)”,”subtitle”:”Sponsored by”,”text”:”\u003cp\u003e\u003cstrong\u003eBackground \u003c/strong\u003eThe purpose of this study is to establish the safety and feasibility of a personalized medicine approach that will be used to select a blood thinner that will be catered to each individual’s unique genetics and needs. This is important for doctors who care for patients with strokes and transient ischemic attacks (TIAs). The medicines that are used in this study are FDA approved.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods \u003c/strong\u003ePatients will receive aspirin or clopidogrel for 21 days; following this, providers will select an antiplatelet medicine that they believe is best for the patient. The patient will be monitored for side effects and tolerance.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDo I qualify?\u003c/strong\u003e If you answer yes to all of the questions below, you may be eligible to participate in the study.\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eDo you meet the criteria for a World Health Organization’s definition of a stroke, clinical stroke, or high-risk TIA?\u003c/li\u003e\n\u003cli\u003eIs the stroke mild or moderate in nature (National Institutes of Health Stroke Scale (NIHSS) score less than or equal to 14)?\u003c/li\u003e\n\u003cli\u003eHas it been less than 30 hours since the time of the stroke?\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eExclusion Criteria \u003c/strong\u003ePlease \u003ca href=\u0022https://upstateglobalhealth.org/exclusion-criteria/\u0022 data-type=\u0022URL\u0022 data-id=\u0022https://upstateglobalhealth.org/exclusion-criteria/\u0022 data-rich-text-format-boundary=\u0022true\u0022\u003eclick here\u003c/a\u003e for a list of questions. If you answer yes to any of the questions on the list, then you will not be able to participate in the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterested? \u003c/strong\u003ePlease give us a call at (315)-464-9869 or email us at trials@upstate.edu\u003c/p\u003e”},{“_id”:”cf-cNNT0AXTDnvLVfGvzm4yx”,”_type”:”_”,”category”:[“treatment”],”big_title”:””,”tag”:””,”title”:”Convalescent Plasma Donation Treatment for COVID-19″,”subtitle”:””,”text”:”\u003cp\u003e\u003cstrong\u003eBackground \u003c/strong\u003eThe purpose of this study is to collect and assess plasma from people who have recovered from COVID-19 infection, as well as of those who have received plasma for treatment. Plasma, which is a component of blood, contains antibodies, which are the body’s natural defense against pathogens. Antibodies may play a crucial role in helping to fight COVID-19, especially in severely sick patients. In this study, plasma that is donated by volunteers will be used as an experimental treatment for patients who are currently ill with COVID-19. In addition, investigational assays will be used on samples to determine immune system reaction of plasma donors and recipients in response to COVID-19 infection. These samples may be used for other assays in the future. \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDo I qualify? \u003c/strong\u003eIf you have tested positive for COVID-19 and have been symptom-free for 14 days, you may be able to participate in this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterested? \u003c/strong\u003eContact us! (315)-464-9869 or trials@upstate.edu\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterested to learning more, click here to become a volunteer.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003ca href=\u0022https://upstateglobalhealth.org/clinical-trials/volunteers/become-a-volunteer/\u0022\u003e\u003cstrong\u003eBecome a Volunteer \u0026gt;\u003c/strong\u003e\u003c/a\u003e\u003c/p\u003e\n\u003cp\u003e \u003c/p\u003e”},{“_id”:”cf-YxjFea927_3VcrIPwJ3O8″,”_type”:”_”,”category”:[“vaccine”,”healthy-volunteer”],”big_title”:””,”tag”:””,”title”:”SARS-CoV-2 RNA Vaccine”,”subtitle”:”Sponsored by PfizeSponsored by Pfizer Inc. and BioNTechr Inc. and BioNTech”,”text”:”\u003cp\u003e\u003cstrong\u003ePurpose \u003c/strong\u003eThe purpose of this study is to evaluate the safety, tolerability and effectiveness of the vaccine in healthy adults.\u003c/p\u003e\n\u003cp\u003e\u003cb\u003eBackground \u003c/b\u003eAfter a new respiratory disease by the name of SARS-CoV-2 appeared in Wuhan, China, Pfizer and BioNTech partnered to develop a vaccine that would prevent COVID-19. Vaccines stimulate production of antibodies in your body to help you ward off disease. This research study involves 3 investigational vaccines to prevent COVID-19. The vaccines are all slightly different but work in the same way. The study will also test each of these vaccines at different dosages. These vaccines do not contain the whole virus, nor the parts of the virus that can make you ill; instead the vaccines contain components of the virus’s genetic code, surrounded by fatty particles called lipids. Using the protein-making machinery of your own cells, the genetic code will produce the spike protein that is seen on the outside of the virus. This spike protein will be recognized by the body as a threat, and antibodies against it will be produced that will then help the body fight against COVID-19. They use your own cells’ protein making machinery to produce some, or all, of the spike protein seen on the outside of the virus. This spike protein, made by your own body, may help your body to produce antibodies to fight against COVID-19. \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQualifications \u003c/strong\u003eIn order to qualify for this study, you must meet the criteria listed below?\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eMust be 18-85yrs old and in good health (as determined by the investigator)\u003c/li\u003e\n\u003cli\u003eMust be willing and able to come in for all scheduled visits, and adhere to vaccination plan, lab tests and lifestyle considerations\u003c/li\u003e\n\u003cli\u003eMust complete e-diary for one week following vaccination\u003c/li\u003e\n\u003cli\u003eMust consent to being observed for 30 min after the vaccination\u003c/li\u003e\n\u003cli\u003eMust provide medical records and medical history at initial visit\u003c/li\u003e\n\u003cli\u003eMust consent to a urine pregnancy test for both visits\u003c/li\u003e\n\u003cli\u003eMust consent to a nasal swab for both visits\u003c/li\u003e\n\u003cli\u003eMust use an acceptable form of contraception for the duration of the study\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eTime Commitment\u003c/strong\u003e The first vaccination will take place at the first visit. The second booster vaccination will take plays 19-23 days later, or 56-70 days later depending on the dose of the vaccine that you receive. After receiving both injections, you will be seen 2 weeks, 1 month, 6 months, 12 months, and 24 months after your second vaccine dose.\u003c/p\u003e”},{“_id”:”cf-xaOoA3N4RTOAf_mwOQmnA”,”_type”:”_”,”category”:[“healthy-volunteer”],”big_title”:””,”tag”:””,”title”:”SAB-185″,”subtitle”:””,”text”:”\u003cp\u003e\u003cstrong\u003eTitle \u003c/strong\u003eA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of SAB-185\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePurpose \u003c/strong\u003eTo assess the safety of a new antibody intended to be used for COVID-19. \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBackground \u003c/strong\u003eCurrently, there is an outbreak of respiratory disease caused by a novel coronavirus that was first detected in Wuhan City, Hubei Province, China, and that has now been detected in many locations internationally, including cases in the United States. The virus has been named “SARS‑CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID‑19) as noted in FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID‑19 Pandemic March 2020.There are currently no FDA-licensed treatment or prophylaxis options for COVID-19 and the related pneumonia caused by SARS-CoV-2. SAB-185 (Human polyclonal anti-SARS-CoV-2 antibody) is an option for treatment of COVID-19. SAB Biopharmaceuticals is conducting this study in collaboration with CSL Behring to study SAB‑185 to assess the safety of the treatment. The study will enroll a total of 28 healthy subjects (male and female) between 18-60 years of age.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQualifications \u003c/strong\u003eTo be eligible for this study you must not have:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eKnown autoimmune condition requiring therapy more intensive than intermittent non-steroidal anti-inflammatories in the prior 6 months (for example: rheumatoid arthritis, lupus, inflammatory bowel disease)\u003c/li\u003e\n\u003cli\u003eChronic respiratory disease COPD, emphysema, cystic fibrosis, pulmonary hypertension, or other chronic condition that requires the routine use of supplemental oxygen\u003c/li\u003e\n\u003cli\u003eChronic asthma requiring the use of oral steroids or hospitalization in the last six months\u003c/li\u003e\n\u003cli\u003eRenal failure or renal insufficiency requiring dialysis\u003c/li\u003e\n\u003cli\u003eCongestive heart failure or significant atherosclerotic disease (coronary artery disease or peripheral vascular disease)\u003c/li\u003e\n\u003cli\u003eHypertension\u003c/li\u003e\n\u003cli\u003eDiabetes\u003c/li\u003e\n\u003cli\u003eCurrently vaping or smoking or history of chronic smoking\u003c/li\u003e\n\u003cli\u003eBMI \u0026gt;35\u003c/li\u003e\n\u003cli\u003eAny other underlying medical (cardiac, liver, renal, neurological, respiratory) or psychiatric condition that in the view of the investigator would preclude use of SAB-185\u003c/li\u003e\n\u003cli\u003eKnown IgA deficiency or previous allergic reaction to intravenous immunoglobin (IVIG)/subcutaneous immunoglobin (SCIG)\u003c/li\u003e\n\u003cli\u003ePositive for hepatitis B virus, hepatitis C, or HIV\u003c/li\u003e\n\u003cli\u003eEver screen positive for rheumatoid factor\u003c/li\u003e\n\u003cli\u003eHistory of COVID-19 or positive antibody or PCR (nasal test)\u003c/li\u003e\n\u003cli\u003eHistory of allergy, anaphylaxis, or severe reaction to beef products (including milk and gelatin)\u003c/li\u003e\n\u003c/ul\u003e”},{“_id”:”cf-aTHSU3M6BCIBfS4EpDyOp”,”_type”:”_”,”category”:[“hiv”,”treatment”],”big_title”:””,”tag”:””,”title”:”HIV-1 Treatment for Virologically Suppressed Adults”,”subtitle”:””,”text”:”\u003cp\u003e\u003cstrong\u003eTitle \u003c/strong\u003eA Phase III, randomized, multicenter, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus lamivudine in HIV-1 infected adults who are virologically suppressed\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePurpose \u003c/strong\u003eThe purpose of this study is to determine the efficacy, safety and tolerability of two approved medicines, dolutegravir (DTG) plus lamivudine (3TC) taken together, compared with subjects taking their current tenofovir alafenamide (TAF)-based regimen (TBR) for the treatment of HIV-1 infected adults in whom the HIV-1 virus is currently suppressed. \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBackground \u003c/strong\u003eRecent data have shown that taking DTG + 3TC in combination is as effective over 1 year as a 3-drug regimen in participants newly initiating therapy. Since HIV medicines have to be taken life-long, it is very important to understand the long-term safety and tolerability of DTG + 3TC compared to TBR. The two-drug regimen of DTG and 3TC is considered experimental and is not yet approved for doctors to treat patients with HIV.  About 750 men and women in 10 countries will take part in this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQualifications \u003c/strong\u003eTo be eligible for inclusion in this study, you must meet all of the following criteria:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eAged 18 years or older at the time of signing the informed consent\u003c/li\u003e\n\u003cli\u003eProof of HIV-1 infection\u003c/li\u003e\n\u003cli\u003eDocumented evidence of at least two plasma HIV-1 RNA measurements \u0026lt;50 c/mL in the 12 months prior to screening, one within 6-12 months and one 6 months prior to screening\u003c/li\u003e\n\u003cli\u003ePlasma HIV-1 RNA \u0026lt;50 c/mL at time of screening\u003c/li\u003e\n\u003cli\u003eMust be on uninterrupted ART for at least 6 months prior to screening\u003c/li\u003e\n\u003cli\u003eMale or female\u003c/li\u003e\n\u003cli\u003eCapable of giving signed informed consent\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eA subject will not be eligible for inclusion in this study if any of the following criteria apply:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eWomen who are breastfeeding or plan to become pregnant or breastfeed during the study\u003c/li\u003e\n\u003cli\u003eAny evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease\u003c/li\u003e\n\u003cli\u003eSevere hepatic impairment\u003c/li\u003e\n\u003cli\u003eUnstable liver disease\u003c/li\u003e\n\u003cli\u003eHepatitis B virus\u003c/li\u003e\n\u003cli\u003eAnticipated need for any hepatitis C virus therapy during the first 48 weeks of the study\u003c/li\u003e\n\u003cli\u003eUntreated syphilis infection\u003c/li\u003e\n\u003cli\u003eHistory or presence of allergy or intolerance to the study drugs, their components or drugs of their class\u003c/li\u003e\n\u003cli\u003eOngoing malignancy\u003c/li\u003e\n\u003cli\u003eSubjects who, in the investigator’s judgment, poses a significant suicidality risk\u003c/li\u003e\n\u003cli\u003eTreatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening\u003c/li\u003e\n\u003cli\u003eTreatment with any of the following agents within 28 days of screening: radiation therapy, cytotoxic chemotherapeutic agents, systemic immune suppressants\u003c/li\u003e\n\u003cli\u003eExposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP\u003c/li\u003e\n\u003cli\u003eUse of any regimen consisting of single or dual ART\u003c/li\u003e\n\u003cli\u003eAny evidence of major NRTI mutation or presence of any major INSTI resistance-associated mutation\u003c/li\u003e\n\u003cli\u003eAny verified Grade 4 laboratory abnormality\u003c/li\u003e\n\u003cli\u003eAny drug holiday during the 6 months prior to Screening\u003c/li\u003e\n\u003cli\u003eAny history of switch to another regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy\u003c/li\u003e\n\u003c/ul\u003e”},{“_id”:”cf-7fIHbPj8bR3QVxAcrXwHp”,”_type”:”_”,”category”:[“hiv”,”healthy-volunteer”],”big_title”:””,”tag”:””,”title”:”Effects of cART Long Term Exposure in HIV Infected Adults”,”subtitle”:””,”text”:”\u003cp\u003e\u003cstrong\u003eTitle \u003c/strong\u003eEffects of cART Long-Term Exposure on Neuronal Function and Brain Microstructure in HIV Infected Individuals ART Naïve starting cART.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePurpose \u003c/strong\u003eThe purpose of this study is to determine what effects combination antiretroviral therapy (cART) has on brain function.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBackground \u003c/strong\u003eThere are concerns that long-term exposure to combination antiretroviral therapy may predispose the brain to injury, especially in the older HIV infected subjects. The results from this study may provide further knowledge on how to best minimize the risks of brain injury due to HIV infection itself and those caused by the HIV drugs. This study will last for 2 years and have 5 visits to our office. Approximately 190 subjects will take part in this study. Subjects will be placed into one of three groups; HIV positive subjects starting antiretroviral treatment, HIV positive elite controllers, and HIV negative control subjects. Twenty subjects are expected to participate at Upstate Medical University.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQualifications \u003c/strong\u003ePotential study subjects need to fulfill the entry criteria below, according to group assignment:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e18 years of age or older\u003c/li\u003e\n\u003cli\u003eAble to provide informed consent\u003c/li\u003e\n\u003cli\u003eAble/willing to undergo neuropsychological and imaging testing\u003c/li\u003e\n\u003cli\u003eThe following laboratory values within 60 days prior to baseline: Hemoglobin \u0026gt;9 gm/dL, Serum creatinine \u0026lt; 2 x ULN, AST, ALT, and alkaline phosphatase ≤2x ULN.\u003c/li\u003e\n\u003cli\u003eNegative serum or urine pregnancy test within 3 days prior to baseline if female of reproductive potential\u003c/li\u003e\n\u003cli\u003eSmoking and use of caffeinated drinks will be monitored and time from last use recorded. Subjects will be instructed to avoid smoking and use of caffeinated drinks for at least 2 hours prior to the scheduled imaging section.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eGroup 1 HIV+:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eHIV-1 infection as documented by HIV test or 2 HIV-1RNA values\u0026gt; 2000 copies/mL at a CLIA certified lab.\u003c/li\u003e\n\u003cli\u003eARV drug naive and willingness to begin antiretroviral therapy or have started ARV by no more than 2 weeks from study entry\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eGroup 2 HIV-:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eHIV negative test within 6 months of enrollment\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eGroup 3 Elite Controllers:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eHIV-1 infection as documented by HIV test at a CLIA certified lab., HIV-1RNA values \u0026lt;1000 copies/mL x ≥2 years; CD4 ≥ 400 at screening; no AIDS defining conditions.\u003c/li\u003e\n\u003cli\u003eNo ARV treatment within the last year prior to screening\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eVolunteers will be excluded from participating if they are/have:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eUnable to provide informed consent\u003c/li\u003e\n\u003cli\u003eSevere premorbid or comorbid psychiatric disorders.\u003c/li\u003e\n\u003cli\u003eDementia (subjects that meet HIV-1-associated mild neurocognitive disorder or HIV-associated asymptomatic neurocognitive impairment will not be excluded)\u003c/li\u003e\n\u003cli\u003eChronic seizures, stroke, head trauma resulting in loss of consciousness\u0026gt; 30 min, and multiple sclerosis\u003c/li\u003e\n\u003cli\u003eBrain infection, brain neoplasm, space-occupying brain lesions requiring acute or chronic therapy\u003c/li\u003e\n\u003cli\u003eSubjects with any fungal meningitis, toxoplasmosis, progressive multifocal leukoencephalopathy or CNS lymphoma are excluded from participation\u003c/li\u003e\n\u003cli\u003eActive alcohol and drug abuse or related medical complications within 6 months of study entry including but not limited to seizures, hallucinations, delirium tremens, or being in a detoxification program\u003c/li\u003e\n\u003cli\u003eAny significant systemic condition that that can alter brain function\u003c/li\u003e\n\u003cli\u003eMetallic implant, e.g., in skull, cardiac devices\u003c/li\u003e\n\u003cli\u003eClaustrophobia\u003c/li\u003e\n\u003c/ul\u003e”},{“_id”:”cf-joc4qEqsNg5JZ1INzQ7tb”,”_type”:”_”,”category”:[“healthy-volunteer”,”infection-model”],”big_title”:””,”tag”:””,”title”:”Dengue Human Infection Model Expansion”,”subtitle”:””,”text”:”\u003cp\u003e\u003cstrong\u003eTitle \u003c/strong\u003ePhase One, Open Label Expansion of a Dengue-1-Virus-Live Virus Human Challenge – (DENV-1-LVHC) Virus Strain\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePurpose \u003c/strong\u003eThe purpose of this research study is to increase our understanding of how people respond to a low dose dengue virus injection. A weakened dengue virus is important so that, in the future, we can use it to test whether or not new vaccines or drugs for dengue actually work.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBackground \u003c/strong\u003eDengue is a disease caused by a virus, transmitted by a certain mosquito. When a mosquito carrying the dengue virus bites someone, he or she can get sick with a dengue infection. These infections can be very mild, with little or no symptoms, but may cause fevers, severe headache, nausea, vomiting, muscle and joint pains, pain behind the eyes, and skin rash. This is referred to as an uncomplicated dengue infection. Occasionally the dengue infection can be severe and cause bleeding (hemorrhagic fever) and/or a sudden decrease of the blood pressure (shock). Severe reactions to natural dengue infections are uncommon and occur in less than 1% of all first infection cases. A severe infection from a natural dengue infection can cause death in some cases, mainly in children.\u003c/p\u003e\n\u003cp\u003eThere are 4 types of dengue virus (1, 2, 3, and 4). Each one can make you sick. You usually cannot get sick from the same type twice. You can, however, get sick again if your second infection is with a different type of dengue. Second infections with a different type of dengue may have a more severe illness.\u003c/p\u003e\n\u003cp\u003eThe types of mosquitoes that carry and transmit dengue virus are most frequently found in the tropical areas of the world (for example the Caribbean, South America, Asia, Puerto Rico, and Hawaii). They are present in some southeastern states in the United States (for example, Florida, Texas, Louisiana, Mississippi, Georgia). Except in rare instances, the mosquitoes present in the United States do not have the dengue virus. Therefore, there is a very low risk of contracting the disease in the continental United States compared to areas of the tropics where the disease is commonly present. While an outbreak of dengue occurred in Key West, Florida in 2009-2010, most dengue cases in US citizens are reported from people living in Puerto Rico, the US Virgin Islands, Samoa, and Guam or from travelers coming back from tropical areas. Dengue is now the leading cause of fever-causing illness in US travelers returning from the Caribbean, South America, and Asia.\u003c/p\u003e\n\u003cp\u003eThis study involves injection with a weakened form of dengue virus type 1, using the lowest dosage used in DHIM-1. There are no specific treatments (antibiotic or antiviral medications) available for dengue infection, but other supportive care will be provided, if required. Supportive care may include: medication for management of pain, fever reducing drugs (acetaminophen), the management of fluid loss through oral or intravenous hydration, close monitoring and clinical assessment by a physician, and fluid replacement if required. This supportive care follows the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) guidelines.\u003c/p\u003e\n\u003cp\u003eGiving a controlled infection to test vaccines or to look at the immune system is done for a number of diseases, including malaria. It has been done with dengue viruses in the past. The weakened version of the dengue virus we are using in this study is newly produced, so now we need to carefully study the ways in which this new weakened dengue virus causes illness. We also want to ensure that it can safely cause a mild form of dengue illness that can be used in future research.\u003c/p\u003e\n\u003cp\u003eDr. Stephen J. Thomas from SUNY Upstate Medical University is the principal investigator (PI), which means that he is responsible for conducting the study. This study will involve up to 9 adults.\u003cstrong\u003e \u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQualifications \u003c/strong\u003eTo be eligible for this study you must:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eBe at least 18 years old and no more than 45 years old at time of consent\u003c/li\u003e\n\u003cli\u003eAt least 75% correct on test of your understanding of the information in this informed consent form\u003c/li\u003e\n\u003cli\u003eFor females only, non-pregnant or non-lactating\u003c/li\u003e\n\u003cli\u003eNot be planning to become pregnant or father a child for the duration of the study (6 months) and using contraceptive methods to prevent pregnancy\u003c/li\u003e\n\u003cli\u003eNot be using an intrauterine device or intrauterine system, including Mirena®, due to risk of heavy menstrual bleeding with these devices\u003c/li\u003e\n\u003cli\u003eNot have had heavy menstrual bleeding within the last 6 months\u003c/li\u003e\n\u003cli\u003eHave no fibroids or uterine polyps, endometriosis, adenomyosis, or uterine scarring\u003c/li\u003e\n\u003cli\u003eBe in good health, as determined by medical history and physical examination\u003c/li\u003e\n\u003cli\u003eProvide consent for release of medical history records\u003c/li\u003e\n\u003cli\u003eNot have significant physical findings prior to inoculation\u003c/li\u003e\n\u003cli\u003eNot have active Diabetes or active peptic ulcer disease\u003c/li\u003e\n\u003cli\u003eNot have chronic obstructive pulmonary disease or coronary artery disease\u003c/li\u003e\n\u003cli\u003eNot have a history of, or current, auto-immune disease\u003c/li\u003e\n\u003cli\u003eNot have a history of Guillain-Barré syndrome\u003c/li\u003e\n\u003cli\u003eNot have been diagnosed with Bipolar Disorder or Schizophrenia, been hospitalized in the past year for a mental health disorder, or any other psychiatric condition, which in the opinion of the investigator prevents the subject from participating in the study\u003c/li\u003e\n\u003cli\u003eNot have previously received a licensed or experimental flavivirus vaccine or had dengue or infection with any flavivirus that is related to dengue virus.\u003c/li\u003e\n\u003cli\u003eHave negative blood tests for the presence of antibodies to dengue, West Nile, Yellow Fever, Japanese encephalitis and Zika virus\u003c/li\u003e\n\u003cli\u003eHave negative blood tests for HIV-1, Hepatitis B, and Hepatitis C\u003c/li\u003e\n\u003cli\u003eNot plan to be vaccinated for any flavivirus\u003c/li\u003e\n\u003cli\u003eNot have traveled within the past 4 weeks to an area where dengue infections occur naturally, and not have any planned travel during the study period (6 months)\u003c/li\u003e\n\u003cli\u003eNot plan to participate in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding inoculation, during the study period, or in the 6 months following inoculation\u003c/li\u003e\n\u003cli\u003eNot have had a recent vaccination (within the past 4 weeks) and not planning to receive a vaccination within 4 weeks following inoculation\u003c/li\u003e\n\u003cli\u003eNot have had medicines or therapies that suppress your immune system\u003c/li\u003e\n\u003cli\u003eNot currently be taking anti-coagulant medication, non-steroidal anti-inflammatory\u003c/li\u003e\n\u003cli\u003eNot currently taking Methadone or Suboxone\u003c/li\u003e\n\u003cli\u003eNot have had hives, shortness of breath, swelling of the lips or throat, or hospitalization related to a previous vaccination or have an allergy to specific medications/animals for which antigens may be in the virus preparations to include: Shellfish, Fetal Bovine Serum, L-Glutamine, Neomycin, and Streptomycin\u003c/li\u003e\n\u003cli\u003eNot have a history of chronic migraine headaches\u003c/li\u003e\n\u003cli\u003eNot have a recent blood donation (56 days) and not planning to donate blood for 1 year after receiving the dengue infection\u003c/li\u003e\n\u003cli\u003eNot planning to receive blood products or antibodies within 56 days of inoculation or during the study period\u003c/li\u003e\n\u003cli\u003eHave negative urine screen for cocaine, amphetamines, or opiates\u003c/li\u003e\n\u003cli\u003eNot have beliefs that prohibit the administration of blood products or transfusions\u003c/li\u003e\n\u003cli\u003eBe able to read, sign, and date this informed consent\u003c/li\u003e\n\u003c/ul\u003e”},{“_id”:”cf-4cN6r2SpNj_uwXfwKKMIL”,”_type”:”_”,”category”:[],”big_title”:””,”tag”:””,”title”:”HIV-1 Treatment using a Long Acting Single Agent”,”subtitle”:””,”text”:”\u003cp\u003e\u003cstrong\u003eTitle \u003c/strong\u003eA Multicenter Study to Assess the Clinical Safety and Treatment Strategy of Using PRO 140 SC as Long-Acting Single-Agent Maintenance Therapy for 48 Weeks in Virologically Suppressed Subjects with CCR5-tropic HIV-1 Infection \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePurpose \u003c/strong\u003eThis study will help us to find out how safe and how well the study product, PRO 140 monotherapy, works in comparison to the combination of oral antiretroviral drugs for the maintenance of viral suppression in HIV-1 patients. \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBackground \u003c/strong\u003eThe safety and effectiveness of PRO 140 has been previously evaluated in 174 people in previous studies. The product used in this study is an investigational drug. An investigational drug is one not approved by the U.S. Food and Drug Administration (FDA). The results of these studies will be used to design future studies to improve treatment of HIV-1 infection. About 500 subjects will enroll in the study across 60 centers within the USA. Approximately 10 subjects will enroll at SUNY Upstate Medical University.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQualifications:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePotential subjects are required to meet all of the following criteria for enrollment into the study.\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eReceiving combination antiretroviral therapy for last 24 weeks\u003c/li\u003e\n\u003cli\u003eNo change in antiretroviral regimen within last 4 weeks prior to Screening Visit and in-between Screening Visit and First Treatment Visit.\u003c/li\u003e\n\u003cli\u003eSubject has two or more potential alternative approved antiretroviral drug options to consider.\u003c/li\u003e\n\u003cli\u003eDocumented Exclusive CCR5-tropic virus at Screening Visit as determined by Trofile? DNA Assay\u003c/li\u003e\n\u003cli\u003ePlasma HIV-1 RNA \u0026lt; 50 copies/mL at Screening Visit as determined by Human Immunodeficiency Virus 1 Quantitative, RNA (Taqman? Real-Time PCR)\u003c/li\u003e\n\u003cli\u003eNo documented detectable viral loads within the last 24 weeks prior to Screening Visit\u003c/li\u003e\n\u003cli\u003eCD4 cell count of \u0026gt; 200 cells/mm3 since initiation of anti-retroviral therapy\u003c/li\u003e\n\u003cli\u003eCD4 cell count of \u0026gt; 350 cells/mm3 in preceding 24 weeks and at Screening Visit\u003c/li\u003e\n\u003cli\u003eLaboratory values at Screening that meet protocol criteria\u003c/li\u003e\n\u003cli\u003eClinically normal resting 12-lead ECG at Screening Visit\u003c/li\u003e\n\u003cli\u003eBoth male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception. Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug\u003c/li\u003e\n\u003cli\u003eWilling and able to participate in all aspects of the study\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003ePotential subjects meeting any of the following criteria will be excluded from enrollment.\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eCXCR4-tropic virus or dual/mixed tropic virus determined by the Trofile? DNA Assay at the Screening Visit\u003c/li\u003e\n\u003cli\u003eHepatitis B infection as manifest by the presence of Hepatitis B surface antigen\u003c/li\u003e\n\u003cli\u003eAny active infection or malignancy requiring acute therapy\u003c/li\u003e\n\u003cli\u003eLaboratory test values ? grade 4 DAIDS laboratory abnormality.\u003c/li\u003e\n\u003cli\u003eFemales who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study\u003c/li\u003e\n\u003cli\u003eUnexplained fever or clinically significant illness within 1 week prior to the first study dose\u003c/li\u003e\n\u003cli\u003eAny vaccination within 2 weeks prior to the first study dose.\u003c/li\u003e\n\u003cli\u003eSubjects who have failed on a maraviroc containing regimen.\u003c/li\u003e\n\u003cli\u003eSubjects weighing \u0026lt; 35kg\u003c/li\u003e\n\u003cli\u003eHistory of anaphylaxis to any oral or parenteral drugs\u003c/li\u003e\n\u003cli\u003eHistory of Bleeding Disorder or patients on anti-coagulant therapy (except aspirin)\u003c/li\u003e\n\u003cli\u003eParticipation in an experimental drug trial(s) within 30 days of the Screening Visit\u003c/li\u003e\n\u003cli\u003eAny known allergy or antibodies to the study drug or excipients\u003c/li\u003e\n\u003cli\u003eTreatment with any of the following:\u003c/li\u003e\n\u003cli\u003eRadiation or cytotoxic chemotherapy with 30 days prior to the screening visit\u003c/li\u003e\n\u003cli\u003eImmunosuppressants within 60 days prior to the screening visit\u003c/li\u003e\n\u003cli\u003eImmunomodulating agents, hydroxyurea, or foscarnet within 60 days prior to the screening visit\u003c/li\u003e\n\u003cli\u003eOral or parenteral corticosteroids within 30 days prior to the Screening Visit. Subjects on chronic steroid therapy \u0026gt; 5 mg/day will be excluded with the following exception, subjects on inhaled, nasal, or topical steroids will not be excluded\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eAny other clinical condition that, in the Investigator’s judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.\u003c/p\u003e”},{“_id”:”cf-5EtD6u9AgXZnLeAPAUVUu”,”_type”:”_”,”category”:[“healthy-volunteer”,”diagnostic”],”big_title”:”Recently Completed Trials”,”tag”:””,”title”:”Specimen Acquisition for Viral Hepatitis”,”subtitle”:””,”text”:”\u003cp\u003e\u003cstrong\u003eTitle \u003c/strong\u003eSpecimen Acquisition for Viral Hepatitis – Analytical Collection Study\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePurpose \u003c/strong\u003eThe purpose of this research study is to obtain blood samples that will be used to demonstrate the safety and effectiveness of several hepatitis and other infectious disease laboratory tests. \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBackground \u003c/strong\u003eThis specimen acquisition study is being conducted to obtain blood samples from adult, pregnant and pediatric subjects that will be used to demonstrate the safety and effectiveness of several Roche hepatitis and/or other infectious disease tests over a period of several years. Clinical performance must be demonstrated for new tests to be approved by FDA for use by doctors. Samples will be collected from subjects according to the study protocol. The blood sample will be kept frozen and used for testing in several new assays to create the data required for FDA test approval.\u003c/p\u003e\n\u003cp\u003eAbout 2300 adult, 200 pregnant and 200 pediatric subjects will take part in this study collected over approximately 6 months at several different study sites. Your study doctor will enroll a share of the total subjects listed.  This study site will only enroll subjects 18 years of age or older.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQualifications \u003c/strong\u003eYou might qualify if you meet any of the criteria below:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eRecipient of blood transfusions before July 1992\u003c/li\u003e\n\u003cli\u003eRecipient of solid organ transplant before July 1992\u003c/li\u003e\n\u003cli\u003eRecipients of clotting factors before 1987 (hemophiliacs)\u003c/li\u003e\n\u003cli\u003eRecipient of blood or organs from a donor that was HCV-positive\u003c/li\u003e\n\u003cli\u003eReceived long-term (chronic) hemodialysis treatments\u003c/li\u003e\n\u003cli\u003eHIV infected or immunocompromised\u003c/li\u003e\n\u003cli\u003ePersons born in countries with high rates of hepatitis (Africa, Asia and Pacific Islands)\u003c/li\u003e\n\u003cli\u003eFamily history of any hepatitis\u003c/li\u003e\n\u003cli\u003eChildren born to hepatitis-positive mothers\u003c/li\u003e\n\u003cli\u003eHave abnormal liver tests or liver disease\u003c/li\u003e\n\u003cli\u003eTattoo artists\u003c/li\u003e\n\u003cli\u003eHealth care worker after needle stick or exposure involving HCV-positive blood\u003c/li\u003e\n\u003cli\u003eMorticians\u003c/li\u003e\n\u003cli\u003eCommercial sex workers\u003c/li\u003e\n\u003cli\u003eIV drug users (current and past)\u003c/li\u003e\n\u003cli\u003eIndividuals sharing straw cocaine\u003c/li\u003e\n\u003cli\u003eIndividuals with tattoo or body piercing that was performed by non-licensed or nonprofessional facilities\u003c/li\u003e\n\u003cli\u003eIndividuals with history of incarceration\u003c/li\u003e\n\u003cli\u003eMultiple sex partners (two or more partners in the past 12 months)\u003c/li\u003e\n\u003cli\u003eEngaging in sex with partner(s) with history of hepatitis\u003c/li\u003e\n\u003cli\u003eEngaging in sex with HIV-infected partner(s)\u003c/li\u003e\n\u003cli\u003eDiagnosed with STD’s (chlamydia, gonorrhea, herpes, syphilis, etc.)\u003c/li\u003e\n\u003cli\u003eMale-on-male sex partner(s)\u003c/li\u003e\n\u003cli\u003eEngaging in sex with commercial sex workers\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003ca href=\u0022https://upstateglobalhealth.org/clinical-trials/volunteers/become-a-volunteer/\u0022\u003e\u003cstrong\u003eBecome a Volunteer \u0026gt;\u003c/strong\u003e\u003c/a\u003e\u003c/p\u003e”},{“_id”:”cf-6GspyST3Gi0aDYWI9EFU2″,”_type”:”_”,”category”:[“healthy-volunteer”,”infection-model”],”big_title”:””,”tag”:””,”title”:”Dengue Human Infection Model (DHIM-1)”,”subtitle”:””,”text”:”\u003cp\u003e\u003cstrong\u003eTitle \u003c/strong\u003ePhase One, Open Label, Assessment of a Dengue-1-Virus- Live Virus Human Challenge (DENV-1-LVHC) Virus Strain\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePurpose \u003c/strong\u003eThe purpose of this research study is to determine if we can develop this weakened dengue virus to safely produce mild dengue symptoms in a human. We want a weakened dengue virus so, in the future, we can use it to test whether or not new vaccines or drugs for dengue actually work. This study will last 6 months and have approximately 21 visits to our office.\u003c/p\u003e\n\u003cp\u003e\u003cb\u003eBackground \u003c/b\u003eDengue is a disease caused by a virus that is transmitted by a mosquito. When someone is bitten by a mosquito carrying dengue virus, they can become sick with a dengue infection. These infections can be very mild, with little or no symptoms, but may cause fevers, severe headache, nausea, vomiting, muscle and joint pains, pain behind the eyes, and skin rash. This is referred to as an uncomplicated dengue infection. Occasionally the dengue infection can sometimes be severe and cause bleeding (hemorrhagic fever) and/or a sudden decrease of the blood pressure (shock). Severe reactions to natural dengue infections are uncommon and occur in less than 1% of all first infection cases. A severe infection from a natural dengue infection can cause death in some cases, mainly in children.\u003c/p\u003e\n\u003cp\u003eThere are 4 types of dengue virus (1, 2, 3, and 4). Each one can make you sick. You usually cannot get sick from the same type twice. You can, however, get sick again if your second infection is with a different type of dengue. Second infections with a different type of dengue may have a more severe illness.\u003c/p\u003e\n\u003cp\u003eThis study involves injection with a weakened form of dengue virus type 1 using 1 of 3 possible dosage strengths (low, medium, or high). There are no specific treatments (antibiotic or antiviral medications) available for dengue infection, but other supportive care will be provided, if required. Supportive care may include: medication for management of pain, fever reducing drugs (acetaminophen), the management of fluid loss through oral or intravenous hydration, close monitoring and clinical assessment by a physician, and fluid replacement if required. This supportive care follows the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) guidelines.\u003c/p\u003e\n\u003cp\u003eThe types of mosquitoes that carry and transmit dengue virus are most frequently found in the tropical areas of the world (for example the Caribbean, South America, Asia, Puerto Rico, and Hawaii). They are present in some southeastern states in the United States (for example, Florida, Texas, Louisiana, Mississippi, Georgia). But except in rare instances, the mosquitoes present in the United States do not have the dengue virus. Therefore, there is a very low risk of contracting the disease in the continental United States compared to areas of the tropics where the disease is commonly present. While an outbreak of dengue occurred in Key West, Florida in 2009-2010, most dengue cases in US citizens are reported from people living in Puerto Rico, the US Virgin Islands, Samoa, and Guam or from travelers coming back from tropical areas. Dengue is now the leading cause of fever-causing illness in US travelers returning from the Caribbean, South America, and Asia.\u003c/p\u003e\n\u003cp\u003eSimilar dengue studies have been done in humans before, using several different weakened dengue viruses. Some of these studies involve people who have been given investigational vaccinations against dengue fever prior to a weakened virus challenge, and some include people who were not vaccinated, but were just given the virus. Most subjects from these previous studies became ill with dengue fever, but some subjects did not become ill. The virus being used in this study is closely related to a version that has been used previously in 11 subjects. All of the previous subjects recovered within 30 days and showed no signs of long-term illness from participation in the study. We cannot guarantee this same recovery period or lack of long-term effects if you decide to participate in this study.\u003c/p\u003e\n\u003cp\u003eGiving a controlled infection to test vaccines or to look at the immune system is done for a number of diseases including malaria. It has been done with dengue viruses in the past. The weakened version of the dengue virus we are using in this study is newly produced, so now we need to carefully study the ways in which this new weakened dengue virus causes illness.\u003c/p\u003e\n\u003cp\u003eWhile there have been other dengue infection trials, including with this type of dengue, this is the first study to use this particular weakened dengue virus in humans. We expect that subjects in this study will get a dengue infection, and this infection may require hospitalization.\u003c/p\u003e\n\u003cp\u003eWe plan to enroll up to 27 subjects in the study. The subjects will be divided into 3 groups who will receive 1 of 3 different doses of the virus, beginning with the lowest dose. If safety issues are found with 1 of the doses, the higher doses will not be given.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQualifications \u003c/strong\u003eTo be eligible for this study you must:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eBe at least 18 years old and no more than 45 years old at time of consent\u003c/li\u003e\n\u003cli\u003eAt least 75% correct on test of your understanding of the information in this informed consent form\u003c/li\u003e\n\u003cli\u003eFor females only, non-pregnant or non-lactating\u003c/li\u003e\n\u003cli\u003eNot be planning to become pregnant or father a child for the duration of the study (6 months) and using contraceptive methods to prevent pregnancy\u003c/li\u003e\n\u003cli\u003eNot be using an intrauterine device or intrauterine system, including Mirena?, due to risk of heavy menstrual bleeding with these devices\u003c/li\u003e\n\u003cli\u003eNot have had heavy menstrual bleeding within the last 6 months\u003c/li\u003e\n\u003cli\u003eHave no fibroids or uterine polyps, endometriosis, adenomyosis, or uterine scarring\u003c/li\u003e\n\u003cli\u003eBe in good health, as determined by medical history and physical examination\u003c/li\u003e\n\u003cli\u003eProvide consent for release of medical history records\u003c/li\u003e\n\u003cli\u003eNot have abnormal lab results or significant physical findings prior to inoculation\u003c/li\u003e\n\u003cli\u003eNot have active Diabetes or active peptic ulcer disease\u003c/li\u003e\n\u003cli\u003eNot have chronic obstructive pulmonary disease or coronary artery disease\u003c/li\u003e\n\u003cli\u003eNot have a history of, or current, auto-immune disease\u003c/li\u003e\n\u003cli\u003eNot have a history of Guillain-Barr? syndrome\u003c/li\u003e\n\u003cli\u003eNot have been diagnosed with Bipolar Disorder or Schizophrenia, been hospitalized in the past year for a mental health disorder, or any other psychiatric condition, which in the opinion of the investigator prevents the subject from participating in the study\u003c/li\u003e\n\u003cli\u003eNot have previously received a licensed or experimental flavivirus vaccine or had dengue or infection with any flavivirus that is related to dengue virus.\u003c/li\u003e\n\u003cli\u003eHave negative blood tests for seroconversion to dengue, West Nile, Yellow Fever, Japanese encephalitis and Zika virus\u003c/li\u003e\n\u003cli\u003eHave negative blood tests for HIV-1, Hepatitis B, and Hepatitis C\u003c/li\u003e\n\u003cli\u003eNot plan to be vaccinated for any flavivirus\u003c/li\u003e\n\u003cli\u003eNot have traveled within the past 4 weeks to an area where dengue infections occur naturally, and not have any planned travel during the study period (6 months)\u003c/li\u003e\n\u003cli\u003eNot plan to participate in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding inoculation, during the study period, or in the 6 months following inoculation\u003c/li\u003e\n\u003cli\u003eNot have had a recent vaccination (within the past 4 weeks) and not planning to receive a vaccination within 4 weeks following inoculation\u003c/li\u003e\n\u003cli\u003eNot have had medicines or therapies that suppress your immune system\u003c/li\u003e\n\u003cli\u003eNot currently be taking anti-coagulant medication, non-steroidal anti-inflammatory drugs\u003c/li\u003e\n\u003cli\u003eNot currently taking Methadone or Suboxone\u003c/li\u003e\n\u003cli\u003eNot have had hives, shortness of breath, swelling of the lips or throat, or hospitalization related to a previous vaccination or have an allergy to specific medications/animals for which antigens may be in the virus preparations to include: Shellfish, Fetal Bovine Serum, L-Glutamine, Neomycin, and Streptomycin\u003c/li\u003e\n\u003cli\u003eNot have a history of chronic migraine headaches\u003c/li\u003e\n\u003cli\u003eNot have a recent blood donation (56 days) and not planning to donate blood for 1 year after receiving the dengue infection\u003c/li\u003e\n\u003cli\u003eNot planning to receive blood products or antibodies within 56 days of inoculation or during the study period (6 months)\u003c/li\u003e\n\u003cli\u003eHave negative urine screen for cocaine, amphetamines, or opiates\u003c/li\u003e\n\u003cli\u003eNot have beliefs that prohibit the administration of blood products or transfusions\u003c/li\u003e\n\u003cli\u003eBe able to read, sign, and date this informed consent\u003c/li\u003e\n\u003c/ul\u003e”},{“_id”:”cf-V6ZyzJLpcBK_wBNbrQF__”,”_type”:”_”,”category”:[],”big_title”:””,”tag”:””,”title”:””,”subtitle”:””,”text”:””}]}} /–>Purpose This study is being conducted to determine if the study product, PRO 140, is safe and if it works to suppress viral load in HIV-1 patients in combination with FDA approved antiretroviral regimens. 

Study This study is being conducted to determine if the study product, PRO 140, is safe and if it works to suppress viral load in HIV-1 patients in combination with FDA approved antiretroviral regimens.

Background The safety and effectiveness of PRO 140 has been previously evaluated in 174 people in previous studies. The product you will be using is an investigational drug. An investigational drug is one not approved by the U.S. Food and Drug Administration (FDA). The results of these studies will be used to design future studies to try to better understand how to design and implement treatment regimens that will be most successful in treating HIV-1 infection.

Qualifications Potential subjects are required to meet all of the following criteria for enrollment into the study.

  • Age 18 years or above
  • Exclusive CCR5-tropic virus at Screening Visit as determined by Monogram Biosciences Profile Assay
  • Have a history of at least 3 months on current antiretroviral regimen
  • Treatment-experienced HIV-infected patients with documented genotypic or phenotypic resistance to at least one ART drug within three drug classes OR treatment-experienced HIV-infected patients with documented genotypic or phenotypic resistance to at least one ART drug within two drug classes and have limited treatment option.
  • Be willing to remain on treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure
  • Plasma HIV-1 RNA ? 400 copies/mL at Screening Visit as determined by Human Immunodeficiency
  • Virus 1 (HIV-1) Quantitative, RNA (Roche Taqman? Real-Time PCR) and documented detectable viral load (HIV-1 RNA >50 copies/ml) within the last 3 months prior to Screening Visit.
  • Laboratory values at Screening that meet the protocol criteria.
  • Clinically normal resting 12-lead ECG at Screening Visit
  • Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception during the course of the study.
  • Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
  • Willing and able to participate in all aspects of the study

Potential subjects meeting any of the following criteria will be excluded from enrollment.

  • Documented CXCR4-tropic virus or Dual/Mixed tropic (R5X4) virus as determined by HIV-1 tropism assay
  • Patients with no viable treatment options
  • Any active infection or malignancy requiring acute therapy
  • Laboratory test values of ? grade 3 DAIDS laboratory abnormality with the exception of the absolute
  • CD4+ count criterion of < 200/mm3
  • Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
  • Unexplained fever or clinically significant illness within 1 week prior to the first study dose
  • Any vaccination within 2 weeks prior to the first study dose.
  • Subjects weighing < 35kg
  • History of anaphylaxis to oral or parenteral drugs
  • History of Bleeding Disorder or patients on anti-coagulant therapy
  • Participation in an experimental drug trial(s) within 30 days of the Screening Visit
  • Any known allergy or antibodies to the study drug or excipients
  • Treatment with any of the following:
    • Radiation or cytotoxic chemotherapy with 30 days prior to the Screening Visit
    • Immunosuppressants within 60 days prior to the Screening Visit
    • Immunomodulating agents (e.g., interleukins, interferons), hydroxyurea, or foscarnet within 60 days prior to the Screening Visit
  • Oral or parenteral corticosteroids within 30 days prior to the Screening Visit. Subjects on chronic steroid therapy > 5 mg/day will be excluded with the following exception, subjects on inhaled, nasal, or topical steroids will not be excluded.
  • Any other clinical condition that, in the Investigator’s judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy

Effect of Antimalarial Drugs to the Rabies Vaccine

Title Effect of Antimalarial Drugs on the Immune Response to Rabies Vaccine for Post-Exposure Prophylaxis. A Randomized, Open Label Trial in Healthy US Adults Age 18-60 Years

Purpose The purpose of this study is to look at the effect of taking medications that prevent malaria (antimalarials) on the ability of a person’s body to develop the natural immune response to a rabies vaccine. It is thought that taking antimalarials may interfere with this natural reaction and the person may not develop the response necessary to prevent rabies after they have been exposed to it. 

Background The use of antimalarials are important to the US Department of Defense, the current funders of this study, because they deploy soldiers to areas that require them to take antimalarials and they have a high chance of being exposed to rabies. The rabies vaccine used in this study is RabAvert, which is approved by the US Food and Drug Administration (FDA) and is used in this area for pre-exposure immunization in people at risk of contact with rabid animals and for post exposure prevention in people who have been bitten by a rabid or suspected rabid animal? The antimalarial drugs used in this study are Chloroquine, Malarone and Doxycycline. These drugs are all approved by the FDA for the prevention and treatment of malaria. We plan to enroll 100 subjects in the study, being conducted at Upstate Medical University.

Time Commitment This study will last 3 months and have 8-11 visits in our office.

Qualifications Subjects must meet all of the following criteria in order to be eligible for trial enrollment:

  • Provide signed and dated informed consent form
  • Willing to comply with all study procedures and be available for the duration of the study
  • Male or female, aged ? 18 to ? 60 years on day of inclusion
  • In good general health based on medical history and physical exam

A subject fulfilling any of the following criteria will be excluded from trial enrollment:

  • Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post- menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination.)
  • Participation in the 4 weeks preceding the first trial vaccination, or planned participation during the present trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
  • Previous history of receiving the rabies vaccine.
  • Previous history of receiving rabies immune globulin.
  • Any major psychiatric disorder, such as severe depression, severe anxiety disorder, psychosis, schizophrenia, other major psychiatric disorders, or seizures. History of mild depression or anxiety disorder that are well controlled are not exclusion criteria.
  • Use of any immunosuppressive drug at the time of the study or 30 days previously. Topical steroids will not be considered an immunosuppressive drug and their use will not be considered an exclusion criteria.
  • Any immunosuppressive disorder, such as HIV infection, common variable immunodeficiency, active cancers or chemotherapy.
  • History of renal insufficiency or requiring dialysis.
  • Have any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
  • Previous adverse reaction to any of the antimalarial drugs used in this study.

Sample Collection for Evaluation of a Hepatitis A Assay

Title Sample Acquisition/Collection for CIM RD002782 Performance Evaluation: Elecsys Anti-HAV II on the cobas e 601 Immunoassay Analyzer

Purpose The purpose of this study is to aid in the development of a new diagnostic test for the Hepatitis A Virus (HAV). Blood samples are needed to test the ability of the Elecsys Anti-HAV II Assay to reliably detect the presence of the hepatitis A virus. 

Background Hepatitis A is a liver disease caused by the hepatitis A virus. The virus is primarily spread when an uninfected (and unvaccinated) person ingests food or water that is contaminated with the feces of an infected person. The disease is closely associated with unsafe water or food, inadequate sanitation and poor personal hygiene.

Approximately 800 subjects will be recruited to participate in a clinical study. A blood sample is needed to test the ability of the Elecsys? Anti-HAV II Assay to reliably detect the presence of the hepatitis A virus. The test is intended as an aid in the laboratory diagnosis of individuals with acute or past hepatitis A virus infection, or as an aid to determine the presence of an antibody response to HAV in vaccine recipients. To this end the assay has to be tested in individuals that are apparently healthy with an unknown risk for hepatitis A infection.

The study will take place at a minimum of two sites located in geographically diverse sections of the US. No testing device is used in this study.

Time Commitment This study will have 1 visit to our office that will last approximately 1 hour. You will provide a blood sample together with specific medical information. The duration of participation in this study is expected to be approximately 20 minutes or less. 

Qualifications Potential subjects are required to meet all of the following criteria for enrollment into the study.

  • Subjects must be asymptomatic for hepatitis including jaundice, nausea, fatigue, abdominal pain in the last 6 months.
  • Subject age is ?22 years of age
  • Following data must be available: age, gender, race, ethnicity
  • Total serum specimen volume after processing is > 1.0 mL
  • Subject must be able to read/understand and sign the informed consent or have a legal guardian who is willing to give written consent
  • Subjects must successfully complete a general health questionnaire

Potential subjects meeting any of the following criteria will be excluded from enrollment.

  • Subject with increased risk for hepatitis infection according to CDC based on behavior, sexual risk, and/or occupation

The Role of Antibodies in Long-Term Non-Progressing HIV

Title The role of non-broadly neutralizing antibodies targeting gp41 structural epitopes in long term non-progression of HIV infection

Purpose This research is being done to determine if people with HIV who have certain antibody responses in their blood are more likely to maintain adequate CD4 counts off of therapy. We want to learn if the presence of certain antibodies in the blood are more common in individuals infected with HIV who do not show progression of their disease (indicated by maintenance of adequate CD4 levels off therapy). 

Time Commitment We expect a total of about 120 people in this research study from 5 locations within New York, with approximately 79 of those people coming from this site in Syracuse, NY. This study will have 1 visit that will take approximately 15 minutes.

Qualifications You must meet the following criteria in order to qualify for this study:

  • Known HIV infection falling into one of three groups:
    • LTNP CD4 count >350 for a minimum of 7 years off therapy
    • On therapy and maintaining adequate CD4 years off therapy
    • Progressors with CD4 counts <350
  • 18 years or older
  • Male or female
  • Ability to provide informed consen