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AIDS and HIV Related Research

March/April 2002

Volunteer Recruitment

NIH houses the nation's most renowned biomedical research institutions. These studies are conducted by the NIAID and the NIH Clinical Center, located in Bethesda, Maryland. For additional information on the specific studies listed here, contact the appropriate coordinator listed below.


HIV

Studies of Lymphocyte Kinetics Using Stable Isotopes (Deuterium -- 97-I-0191)

Contact: William Sachau, RN 1-800-772-5464 ext. 5-7940

The purpose of this study is to learn more about how quickly blood cells, especially CD4 lymphocytes, replicate and how long they live. Understanding what happens to CD4 lymphocytes in HIV-infected patients should provide a better understanding of how certain therapies, such as antiretroviral treatments and/or IL-2, affect the immune system. Study requirements include admission to the inpatient unit for a 5-day glucose infusion and apheresis procedures during study visits. Participants will be reimbursed for their time and inconvenience.

Interrupted vs. Continuous Anti-Viral Thearpy (HAART) in HIV-Infected Individuals (M77-02-1-0013)

Contact: Diane Rock-Kress, RN 1-800-772-5464 ext. 5-8003

This 72 week study will have 2 groups: one group will continue receiving their current therapy and one group will stop their therapy every other week (7 days). You may be eligible if you are: (1) 18 years or older (2) receiving effective anti-HIV medications with an undetectable viral load for > 1 month (3) have a CD4 T-cell count of > 175 cells/mm³ and (4) NOT receiving nevirapine or abacavir containing regimen. Study related medications and clinical care will be provided during the study. Many studies of HIV and the immune response to HIV will also be done.

Study of Lymphocyte Kinetics Using Bromodeoxyuridine (BrDu)

Contact: Betsey Herpin, RN, MSN 1-800-772-5464 ext. 5-7630

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This study is designed to measure the rate of lymphocyte replication and destruction in persons with HIV infection who have virologic but not immunologic response to HAART. Patients must have a viral load less than 500 copies/ml for greater than one year and less than 50 copies/ml at the NIH, and, (group 1), a CD4 count of less than 300 cells/mm³, or, for comparison, (group 2), a CD4 count of greater than 350 cells/mm³, with a pre-HAART CD4 count of less than 300 cells/mm³. Participants will receive one to two 30-minute infusions of BrDu and will be followed with frequent serial laboratory studies. Additional laboratory studies and a CT scan of the thymus will also be performed. HIV-infected patients with viral loads greater than 20,000 copies/ml will also be evaluated for study participation. Compensation for study participation will be provided.

A Phase III Multicenter Randomized Study of the Biological and Clinical Efficacy of Subcutaneous Recombinant, Human Interleukin-2 in HIV-infected Patients With Low CD4+ Counts Under Active Antiretroviral Therapy (SILCAAT-01-I-0126)

Contact: Linda Coe, RN, MSN 1-800-772-5464 ext. 2-1420

This is an open-label, phase III, multicenter international trial to evaluate and compare the effectiveness of IL-2 combined with antiretroviral therapy, versus antiretroviral therapy alone, on disease progression of people with HIV infection. Patients with CD4 cell counts between 50-299 cells/mm³ will be randomized to receive either subcutaneous IL-2 plus antiretroviral therapy, or antiretroviral therapy alone.

Lymphapheresis (81-I-0164)

Contact: Linda Ehler, RN, MN 1-800-772-5464 ext. 5-7687

This study is seeking HIV-infected volunteers with CD4 counts > 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, Virginia metropolitan area. Financial compensation is provided for participating in this study.

Pregnancy Pharmacokinetics (00-I-0213)

Contact: Barbara Hahn, RN 1-800-772-5464 ext. 5-8007

This study is seeking pregnant HIV-infected women on HAART therapy. The purpose of this study is to see if the amount of antiretroviral drugs in the blood of pregnant women changes during the different stages of pregnancy. Blood samples will be collected intermittently for 12 hours at two to four different time points, every 6-12 weeks. Financial compensation is provided.

ESPRIT Interleukin-2 (00-I-0071)

Contact: Doreen Chaitt, RN, MPH 1-800-772-5464 ext. 5-8008

This is an open label, phase III, international trial to determine if IL-2, combined with antiretroviral therapy, prolongs the health of people with HIV infection. Patients with CD4 cell counts > 300 cells/mm³ will be randomized to receive either subcutaneous IL-2 plus antiretroviral therapy or antiretroviral therapy alone.

Analysis of HIV Genetic Variation (00-CC-0110)

Contact: Diane M. Rock-Kress, RN 1-800-772-5464 ext. 5-8003

This study will attempt to derive a comprehensive description of HIV population genetics. This study seeks men and women who are HIV positive with CD4+ cell counts in all ranges and viral load of at least 1000 copies/ml at time of screening. Participants must be antiretroviral naïve. All participants will have viral load and CD4 testing of blood as well as genotyping/phenotyping of HIV. Two leukophereses (removal of white cells from the blood) are required. Optional are lumbar puncture and lymph node biopsy procedures and semen donation or genital secretion collection for which participants will be compensated.

Use of Combination Antiretroviral Therapy to Delineate the Persistence of HIV Infection (97-I-0082)

Contact: Betsey Herpin, RN, MSN 1-800-772-5464 ext. 5-7630

This study will attempt to identify and define potential reservoirs (sites in the body) of HIV-1 that permit the maintenance of persistent HIV-1 infection and whether antiviral therapy can reverse the effects of HIV-1 infection. The study is seeking men and women who are HIV positive with CD4+ cell counts less than 500. Participants will receive AZT, 3TC, indinavir, and nevirapine therapy for at least 12 months. All participants will have viral load testing of the blood, up to 4 leukophereses (removal of white cells from the blood), and up to 3 lymph node biopsies.


Vaccine

Evaluation of an HIV-1 DNA Vaccine Encoding a Modified Gag-Pol in Uninfected Adult Volunteers (01-I-0079)

Contact: Grace Kelly, RN 1-800-772-5464 ext. 5-7744

The vaccine in this trial, VRC 4302, is classified as a genetic vaccine. Genetic vaccines contain the genes (hereditary material) which direct the production of the proteins of the HIV virus. VRC 4302 contains the gene for the gag and pol proteins of HIV. It is important to know that you cannot catch HIV or AIDS from this vaccine. Volunteers will be randomized in a blinded manner to receive either active vaccine (at one of 3 doses, 0.5 mg, 1.5 mg or 4.0 mg) or vehicle ("control") alone. Participants will receive VRC 4302 by intramuscular injection once a month for 3 months. The injection is given using a needleless injection device. A total of approximately 21 individuals will be evaluated. Volunteers will be evaluated over the course of one year (approximately 15 visits).


Hepatitis

Study of the Safety and Efficacy of the Addition of Adefovir Dipivoxil to Lamivudine for the Treatment of Chronic Hepatitis B in HIV-Infected and HIV-Uninfected Patients (01-I-0239)

This is a randomized placebo-controlled study of the safety and efficacy of the addition of ADV to lamivudine for the treatment of hepatitis B in both HIV positive and negative persons who have persistent HBV viremia and active HBV despite at least a year of lamivudine therapy. Subjects will be randomly allocated to receive either adefovir 10 mg daily or matching placebo. The study duration is 48 weeks with possible open-label ADV extension. Some travel costs will be reimbursed.

Adefovir for Hepatitis B in Patients With HIV Infection (01-I-0134)

This is a single-arm, open-label study of the addition of adefovir at 10 mg/day to lamivudine for the treatment of hepatitis B in people who have HIV infection, HBV viremia of at least 1,000,000 copies/mL, and decompensated HBV-associated liver disease. Participants must have been taking lamivudine (Epivir) for at least the past year and may not have hepatitis C or D or other active serious systemic infections.

Visit the web site: www.niaid.nih.gov/hivclinic.


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This article was provided by Positively Aware. It is a part of the publication Positively Aware. Visit Positively Aware's website to find out more about the publication.
 

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