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HIV Infections clinical trials

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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NCT ID: NCT00078182 Withdrawn - HIV Infections Clinical Trials

Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia

Start date: n/a
Phase: Phase 2/Phase 3
Study type: Interventional

Tenofovir disoproxil fumarate (also known as tenofovir DF or Viread) is used with other anti-HIV drugs to treat HIV infection. Taking tenofovir DF every day may also prevent HIV infection. This study will determine if taking a tenofovir DF tablet every day is safe and effective in preventing HIV infection. Participants in the study will be sex workers in Phnom Penh, Cambodia.

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.

NCT ID: NCT00076947 Completed - HIV Infections Clinical Trials

Safety of the EnvPro HIV Vaccine in Healthy Volunteers

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

The purpose of this study is to determine the safety of a new HIV vaccine. The vaccine in this study is mixed with a chemical called alum to improve the body's response to the vaccine. Healthy adults who are not infected with HIV may participate in the study.

NCT ID: NCT00076817 Completed - HIV Infections Clinical Trials

Safety and Effectiveness of Administering an HIV Vaccine in the Groin Versus the Arm

Start date: June 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety of and immune system response to the ALVAC-HIV (vCP205) vaccine when it is injected either into the groin area or into the arm. The goal is to determine if injecting the vaccine into the groin area produces a better immune response in the lining of the rectum.

NCT ID: NCT00076804 Terminated - HIV Infections Clinical Trials

Helping HIV Infected Patients in South Africa Adhere to Drug Regimens

Start date: February 2005
Phase: Phase 2
Study type: Interventional

Three or more anti-HIV drugs are taken in combination as part of a treatment regimen. These drug regimens must be closely followed in order to be successful. Having a support person watch a patient take his or her anti-HIV drugs each day may help a patient follow his or her regimen. This study will see if patient-chosen treatment supporters help patients take HIV medicines correctly and improve their health. Study hypothesis: The mean change in CD4 count at 12 and 24 months will be significantly higher in the directly observed therapy-highly active antiretroviral therapy (DOT-HAART) arm as compared to the self-administered arm.

NCT ID: NCT00076791 Completed - HIV Infections Clinical Trials

Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants

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

Most infants infected with HIV through mother-to-child transmission (MTCT, or perinatal transmission) become infected during labor and delivery. The purpose of this study is to test the safety and tolerability of a single dose of tenofovir disoproxil fumarate (TDF) or emtricitabine/TDF (FTC/TDF) given at the time of labor to HIV infected pregnant women and to their newborn infants.

NCT ID: NCT00076518 Completed - HIV Infections Clinical Trials

The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART)

Start date: n/a
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effectiveness of fish oil supplements combined with the drug fenofibrate in treating elevated triglyceride levels in people taking anti-HIV drugs. The participants in this study will have shown no response to fish oil supplements or fenofibrate alone.

NCT ID: NCT00076427 Completed - HIV Infections Clinical Trials

Leukapheresis for Research on HCV-Coinfected Patients

Start date: January 14, 2004
Phase: N/A
Study type: Observational

This study will collect quantities of white blood cells from patients infected with the hepatitis C virus (HCV) for research on the interactions between HCV and the human immunodeficiency virus (HIV) in people infected with both of these agents. Several studies have shown that infection with HIV adversely affects liver disease due to HCV. Patients 18 years of age and older who are infected with both HCV and HIV or with HCV alone may be eligible for this study. Candidates must not have liver failure and must not be undergoing treatment for HCV at the time of enrollment. Participants will undergo leukapheresis to collect white blood cells. This procedure allows collection of larger numbers of cells than would be possible with simple blood drawing. For the procedure, blood is removed through a needle in the vein of one arm and spun in a machine that separates the blood into its components. The white cells are extracted and the rest of the blood is re-infused through the same needle or through a needle in the other arm. The procedure takes approximately 1-3 hours, depending on the amount of white cells being collected. A maximum of three leukapheresis procedures are done. If additional procedures are required, the patient will sign a new consent form. Procedures will be limited to no more than three times a year, or once every 4 months.

NCT ID: NCT00076284 Completed - HIV Infections Clinical Trials

GW873140 to Treat HIV-1 Infected Adults

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

This study will determine which of four doses of GW873140 can safely be given to adults to lower the amount of virus (HIV-1) in the body. GW873140 is a new type of anti-HIV drug called a CCR5 receptor antagonist. CCR5 is a receptor on T cells (a type of white blood cell) where HIV-1 enters and then infects the cell. GW873140 is intended to block the CCR5 receptor so that HIV-1 cannot enter the cell. HIV-1-infected patients 18 years of age and older may be eligible for this study. Candidates are screened with a medical history and physical examination, electrocardiogram, and blood and urine tests. Some of the blood drawn is used to test the patient's HIV-1 type to see if the study drug might lower the amount of HIV-1 in the blood. Women who can become pregnant have a pregnancy test. Participants are hospitalized for 12 days. They are randomly assigned to take one of the following four treatments for 10 days: 1) 200 mg of GW873140 once a day, or placebo (a look-alike pill with no active ingredient); 2) 200 mg of GW873140 twice a day, or placebo; 3) 400 mg of GW873140 once a day, or placebo; or 600 mg of GW873140 twice a day, or placebo. Participants record the meals they eat on a diary card. In addition, they undergo the following tests and procedures: During treatment - Assessment of HIV classification (day 1) - Review of meal diary cards (days 1,2,3,4,5,8, and 10) - Review of any HIV-associated conditions, other medications taken besides the study drug, and well-being (days 1,2,3,4,5,8,10, and 11) - Check of vital signs, including blood pressure, pulse, and temperature (days 1,2,3,4,5,6,7,8,10, and 11) - Weight assessment (days 1 and 10) - Electrocardiogram to measure the electrical activity of the heart (days 1,2,3,8, and 10) - Blood draws for routine laboratory tests, to measure T-cell counts, and to measure HIV levels (days 1,2,5,10, and 11) - Urine tests (days 1 and 10) Post-treatment - Blood tests to monitor the effect of GW873140 on lowering HIV counts (days 12, 15, 17, and 19) Follow-up visit (2 weeks after last drug dose--day 24) - Review of medications taken and general well-being - Check of vital signs - Physical examination - Blood and urine tests.