Upstate Medical University

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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 18-50 who answers no to all of the following questions, you may be eligible to participate in this study.

  • Are you younger than 18 or older than 50 years old?
  • Are you currently taking any medications with the exception of Tylenol and/or hormone replacement therapy?
  • 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 received or plan to receive any vaccines 14 days prior to the start 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 30?

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.

Become a Volunteer

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.

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!

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

Active Trials: Not Enrolling

SARS-CoV-2 RNA Vaccine

Sponsored by Pfizer 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

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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.

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