NIAID HIV and Emerging Infectious Diseases Program

HIV Studies

Volunteer Recruitment

The National Institutes of Health (NIH) houses the nation’s most renowned biomedical research institutions. These studies are conducted by NIAID and the NIH Clinical Center in Bethesda, Maryland. For specific information on these studies, contact a study coordinator listed below.

A Cohort Observational Study Evaluating the Incidence and Immunopathogenesis of Immune Reconstitution Syndrome (IRIS) in HIV-1 Infected Patients with CD4 Count less than or equal to 100 Cells/microL who are Initiating Antiretroviral Therapy

(IRIS – Protocol #06-I-0086)

We will evaluate patients who are initiating antiretroviral therapy (ART) for HIV to see if they develop conditions that may be related to immune reconstitution syndrome (IRIS). The purpose is to study what factors may lead to IRIS, what the outcome is after IRIS, and how to better define IRIS. The study is open to HIV+ participants 18 years of age and older who have a primary care physician. Participants must have a T-cell count less than or equal to 100. Participants must live within a 120-mile radius from NIH in Bethesda, Maryland. Volunteers will be compensated.

Leukapheresis Procedures to Study HIV-Specific Immunity

(LTNP – Protocol #02-I-0086)

We will evaluate patients who have been able to control the progression of HIV for long periods without the use of antiretroviral therapy. Some immune system-related genes have been identified in people who are often labeled “long-term non-progressors” (LTNP). These HLA genes include B27, B35, B44, B57, B58, and/or A02. We will conduct genetic testing, blood collection, and tissue sampling in the hope of better understanding how some rare individuals can suppress HIV without medications. Volunteers will be compensated.

A Pilot Study of Hepatic Fibrosis in HIV/AIDS Patients with Chronically Elevated Transaminases on Antiretroviral Therapy

(TRANSAM – Protocol #06-CC-0153)

NIH is conducting a research study to evaluate HIV-positive patients, aged 18 and older, (without HBV or HCV co-infection) with chronically elevated hepatic transaminases while on HAART for evidence of fibrosis or other liver pathology by examining liver biopsy specimens. The study will include a screening visit, physical exam, laboratory tests, abdominal CT, and a liver biopsy procedure. A specialized ultrasound to look at liver stiffness may also be performed. There will be up to four visits prior to liver biopsy and four follow-up visits after biopsy. Financial compensation will be provided for visits completed.

Effect of Early Antiretroviral Therapy on Maintenance of Immune Cell Function

(RPHI – Protocol #02-I-0202)

This study is recruiting volunteers either at the Acute (early signs and symptoms of HIV infection and/or less than four months of known HIV exposure) and Chronic stage (greater than six months or determinate positive result) of infection and who have elected to begin HAART (provided by participant's Primary Care Provider). The study will require that patients be apheresed once before antiretroviral therapy and several times after suppression of plasma viremia (less than 50). Travel assistance will be provided (for non-local volunteers). Participants will be reimbursed for their time and inconvenience.

Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research on HCV-Infected Patients

(HCVRES – Protocol #04-I-0086)

Determining how the immune system of some patients is able to control hepatitis C virus (HCV) is felt to be a very important step for designing vaccines and therapies for HCV. Several studies have shown that coinfection with HIV adversely affects liver disease due to HCV. Our laboratory is recruiting patients to further understand the mechanism(s) involved in the interactions between HCV and HIV and how such interactions affect the progression of one another. In addition, for purposes of comparison, patients who are infected with HCV alone are also being recruited.

Strategic Timing of Anti-Retroviral Treatment

(START – Protocol #09-I-0108)

NIH is conducting a research study to evaluate the timing of when it is best to start taking HIV medications. Most guidelines agree that if the number of your CD4+ cells (cells in your blood which help fight infection) drops below 350 cells/mm³, or if you have symptoms of AIDS, you should start taking HIV medicines. In contrast, if your CD4+ cell count is above 350 cells/mm³, most current guidelines do not recommend starting HIV medicines right away. However, there is an increasing amount of evidence to suggest that in some cases this delay could be harmful. In order to answer this question definitively, NIH will be conducting a study comparing immediate versus delayed therapy in patients early in the course of their HIV infection (CD4+ cell counts ≥ 500 cells/mm³).

This study will be randomized; some participants will start HIV medications immediately, and some will be selected at random to start HIV medications following the current guidelines outlined above. Participation in the study will be approximately three years, and HIV medications will be provided, as indicated.

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