NIAID HIV and Emerging Infectious Diseases Program

HIV Studies

Volunteer Recruitment

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

For questions about participating in any of these clinical studies, contact: Patient Recruitment and Public Liaison Office Toll Free: 1-800-411-1222 TTY: 1-866-411-1010 Se habla español. Office hours: 8 am to 8 pm, Eastern Time

A Phase I/IIa Randomized Placebo Controlled, Single-Blind Multicenter Dose-Escalation Study of Subcutaneous Intermittent Interleukin-7 CYT107 in Chronically HIV-Infected Patients with CD4 T-Lymphocyte Counts Between 101-400 Cells/mm(3) and Plasma HIV RNA Less Than 50 Copies/ml After at Least 12 Months of HAART

(INSPIRE – Protocol #07-I-0155)

The NIH is conducting a research study to evaluate the safety and biologic activity of Interleukin-7 (IL-7), which is intended to increase the number and improve the function of T-lymphocytes in individuals with HIV infection. The study is placebo-controlled, and you will have a four times greater chance at getting actual IL-7 over the placebo. You will receive IL-7 (or placebo) by injection on three separate days, and have about 13 visits over 52 weeks. Volunteers will be compensated.

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 the NIH in Bethesda, MD. 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)

The 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 4 months of known HIV exposure) and Chronic stage (greater than 6 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.

Lymphapheresis

(RASFA – Protocol #81-I-0164)

This study is seeking HIV-infected volunteers with CD4 counts greater than 200. Volunteers will participate in a 45-minute apheresis procedure involving removal of some white blood cells from the circulating blood. Study is only recruiting patients residing in the Washington, DC, Maryland, and Virginia metropolitan area. Financial compensation is provided for participating in this study.

Correlation of the Precursor Frequency of CD4 + Effector Memory T Cells with Induration Measured in the Tuberculin Skin Test

(TST – Protocol #06-I-0030)

The NIH is conducting a research study to investigate the human immune response to tuberculosis infection. Volunteers over 18 years old who have not been treated for tuberculosis are eligible to participate. The study involves up to 6 visits for placement of a tuberculin skin test and follow-up blood tests. The study is recruiting patients residing in the Washington, DC, Maryland, and Virginia metropolitan area. Volunteers will be compensated.

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 human immunodeficiency virus (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.

An Open Label Non-Randomized Trial to Assess Safety and Tolerability of Alb-interferon Alfa 2b Every Two Weeks with Ribavirin Among HIV/HCV Coinfected Individuals

(ALBIN – Protocol #07-I-0001)

This research will examine the safety and toxicity profiles, as well as the pharmacokinetics and effect on HCV viral kinetics, of Alb-interferon (ALB-IFN) when given to patients who are co-infected with HCV and HIV. ALB-IFN has been genetically fused to human serum albumin in order to increase its half-life and subsequently decrease the frequency of injections required to achieve the same therapeutic effect as current Interferon therapy. The study will also assess the potential efficacy of ALB-IFN with ribavirin (RBV). RBV is a medication, in pill form, which is already approved by the FDA to treat chronic Hep C infection.

Pioglitazone for Hepatic Steatosis in HIV/HCV Co-infection

(PATCH – Protocol #08-I-0201)

This study will evaluate the potential benefits of 48 weeks of pioglitazone therapy on fatty liver (hepatic steatosis) in HIV/HCV co-infected men and women compared to placebo. The trial will be 96 weeks in duration with a 48-week open-label treatment extension following the 48-week randomized placebo-controlled treatment phase. Subjects will be required to have evidence of hepatic steatosis on biopsy for eligibility.

For questions about participating in any of these clinical studies, contact: Patient Recruitment and Public Liaison Office Toll Free: 1-800-411-1222 TTY: 1-866-411-1010 Se habla español. Office hours: 8 am to 8 pm, Eastern Time

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