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HIV Infections clinical trials

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NCT ID: NCT00080431 Completed - HIV Infections Clinical Trials

Daclizumab to Treat HIV-Infected Patients

Start date: March 26, 2004
Phase: Phase 1
Study type: Interventional

This study will examine the safety and effectiveness of daclizumab (also called Zenapax or anti-CD25) in reducing viral replication in patients with HIV infection. Although HAART, an intensive anti-HIV treatment regimen, can suppress HIV in blood below the limit of detection, it cannot completely eradicate the virus. This study will focus on the effectiveness of daclizumab in further reducing viral replication in patients with low viral counts. The Food and Drug Administration approved daclizumab in 1997 for preventing kidney transplant rejection, and it has also been studied in people with an eye infection called uveitis. The drug works by binding to a protein on T cells (white blood cells of the immune system) called CD25. This prevents another protein, called interleukin-2 (IL-2), from binding to this site, thus preventing a series of events that normally results in inflammation. Patients between 18 and 65 years of age with HIV infection who have stable HIV levels at less than 30,000 copies/mL of blood and CD4 T cell counts higher than 400 cells/cmm may be eligible for this study. Patients who have taken drugs that affect the immune system, such as IL-2 and interferon, in the past 5 years may not participate. Candidates are screened with a comprehensive medical examination, including physical examination and laboratory studies. X-rays, consultations, and biopsies are done only if medically indicated. Participants will undergo the following tests and procedures: - Daclizumab therapy: Patients receive daclizumab as a 25-minute infusion through an intravenous catheter (plastic tube placed in a vein) at the NIH Clinical Center outpatient clinic. A total of three doses of drug are given. The first dose is given on study day 1, the second dose is given 2 weeks later, and the third dose is given 4 weeks later. Patients are observed for at least 1 hour after each infusion before being discharged from the clinic. - Follow-up visits: Patients return to the outpatient clinic every 2 weeks while they are on medication and then every month until 3 months after the final dose to evaluate their infection status, response to therapy, and medication side effects. The visits include a physical examination, blood draws, and possibly x-rays, if medically indicated. - Apheresis: Patients undergo apheresis, a procedure for collecting large amounts of white blood cells, three times during the study - once before starting daclizumab therapy, 4 weeks after beginning therapy, and 12 weeks after beginning therapy. For apheresis, blood is removed through a needle in the vein of one arm and spun in a machine that separates it into its components. The white blood cells and plasma are removed, and the red cells and platelets are re-infused either through the same needle or through a needle in a vein in the other arm.

NCT ID: NCT00080106 Completed - HIV Infections Clinical Trials

Effectiveness of and Immune Response to HIV Vaccination Followed by Treatment Interruption in HIV Infected Patients

Start date: June 2004
Phase: Phase 2
Study type: Interventional

HIV vaccines may help the immune systems of HIV infected patients better control the virus. The goal of this study is to determine whether patients on anti-HIV medications can stop taking those medications if they receive an HIV vaccine. While taking anti-HIV medications, participants will receive either an HIV vaccine or a placebo. Participants will then stop taking their anti-HIV medications and the study will compare the viral loads of participants who received the vaccine with the viral loads of participants who received the placebo. Primary study hypotheses: 1)The Week 12 and Week 16 post-ART interruption geometric mean HIV-1 RNA levels will be lower among participants who had received MRK Ad5 vaccine prior to ART interruption than among participants who received placebo; 2) the time averaged area under the curve of the log10 HIV-1 RNA copies/ml versus day function in the 16 week post-ART interruption step will be lower among participants who received the MRK Ad5 vaccine prior to ART interruption than among participants who receive placebo.

NCT ID: NCT00079729 Completed - HIV Infections Clinical Trials

Directly Observed Therapy in HIV Infected Adolescent Focus Groups

Start date: April 2004
Phase: N/A
Study type: Observational

The purpose of this study is to help researchers use information from HIV infected adolescents to design a directly observed therapy (DOT) program that will help adolescents take their anti-HIV medications correctly.

NCT ID: NCT00079599 Completed - HIV Infections Clinical Trials

L-Carnitine to Treat Fatigue in AIDS Patients

Start date: November 2002
Phase: Phase 2
Study type: Interventional

Patients with AIDS may develop a deficiency of the micronutrient carnitine and such a deficiency may contribute to fatigue in these patients. This study will determine whether carnitine supplementation will improve fatigue and related symptoms in carnitine-deficient patients with AIDS.

NCT ID: NCT00079560 Completed - HIV Infections Clinical Trials

Comparing the Effects of Smoked and Oral Marijuana in Individuals With HIV/AIDS

Start date: December 2001
Phase: Phase 1/Phase 2
Study type: Interventional

Smoked marijuana (MJ) and dronabinol (also known as THC or by the trade name Marinol) are used to increase appetite, food intake, and weight in patients with HIV who experience unintended weight loss. This study will compare the effects of MJ and Marinol use in marijuana smokers who are HIV infected.

NCT ID: NCT00079534 Completed - HIV Infections Clinical Trials

Distant Healing for HIV/AIDS

Start date: December 2000
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether individuals praying at a distance (also known as "Distant Healing") can positively affect the health of people with HIV/AIDS.

NCT ID: NCT00078442 Completed - HIV Infections Clinical Trials

Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People

Start date: May 2006
Phase: Phase 2
Study type: Interventional

Recombinant interferon (IFN) may be useful in the treatment of HIV. However, the high doses of IFN necessary to keep HIV under control limit its use due to toxic side effects. The purpose of this study is to test the safety and tolerability of weekly recombinant pegylated interferon (PEG-IFN) alfa-2a in HIV infected people who are currently on antiretroviral therapy (ART) interruption or who have not started taking anti-HIV drugs.

NCT ID: NCT00078403 Completed - HIV Infections Clinical Trials

Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV)

Start date: July 2004
Phase: Phase 2
Study type: Interventional

Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and ribavirin treatment in slowing liver disease progression in people infected with both HIV and HCV.

NCT ID: NCT00078247 Completed - HIV Infections Clinical Trials

Anti-HIV Drugs for Ugandan Patients With HIV and Tuberculosis

Start date: October 2004
Phase: Phase 3
Study type: Interventional

This study is designed to determine whether 6 months of anti-HIV drugs given along with tuberculosis treatment will delay the onset of AIDS in HIV infected African patients.

NCT ID: NCT00076999 Completed - HIV Infections Clinical Trials

Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children

Start date: November 2003
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide information concerning the pharmacokinetic characteristics of tipranavir and ritonavir in this age group, and to determine the relative bioavailability of the TPV liquid formulation and TPV capsule formulation in adolescents switching from liquid to capsule. The secondary objective of this study is the determination of the dose of topranavir and ritonavir (TPV/r) in children and adolescents between 2 and 18 years of age required for an adult equivalent systemic exposure of TPV/r 500 mg / 200 mg.