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HIV Infections clinical trials

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NCT ID: NCT00056641 Completed - HIV Infections Clinical Trials

Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients

Start date: February 18, 2003
Phase: Phase 2
Study type: Interventional

This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients. The primary objective is to determine the safety and pharmacokinetics of: TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).

NCT ID: NCT00055341 Completed - HIV Infections Clinical Trials

Treatment of Hepatitis C in Hemophilic Patients With HIV

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

Pegylated interferon (PEG-interferon) and ribavirin are accepted treatments for hepatitis C virus (HCV) infection. However, HCV infection progresses differently in patients who are coinfected with HIV and in hemophiliacs. This study will evaluate the effectiveness of PEG-interferon and ribavirin for treating HCV in HIV infected hemophiliacs.

NCT ID: NCT00055237 Completed - HIV Infections Clinical Trials

Bevacizumab to Treat Kaposi's Sarcoma in HIV-Positive and HIV-Negative Patients

Start date: February 2003
Phase: Phase 2
Study type: Interventional

This study will examine the safety and effectiveness of the experimental drug bevacizumab for treating both non-acquired immune deficiency syndrome (AIDS) and AIDS-associated Kaposi's sarcoma (KS). KS tumors depend on the formation of new blood vessels for their growth. Bevacizumab is an antibody to a protein called vascular endothelial growth factor (VEGF) that is produced by the body and is involved in blood vessel growth. Bevacizumab may block the action of VEGF, and thus help shrink KS lesions. Patients 18 years of age and older with Kaposi's sarcoma that is restricted to the skin and is not life threatening may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), chest x-ray, and, if needed, imaging studies to evaluate internal tumors. Participants will receive bevacizumab intravenously (by vein) once a week for 2 weeks and then every 3 weeks at the National Institutes of Health (NIH) Clinical Center. The first infusion takes about 90 minutes, the second takes about 60 minutes, and subsequent infusions take about 30 minutes. Infusions may take longer, however, if the drug is better tolerated at a slower infusion rate. Patients will be evaluated with the following tests and procedures: - Physical examination, assessment of drug side effects, measurement of KS lesions, and photographs of lesions once a week for the first 6 weeks of therapy, and then every 3 weeks. - cluster of differentiation 4 (CD4) cell counts and human immunodeficiency virus (HIV) viral load in HIV-positive patients every 12 weeks. - Biopsies of lesions: upon entering the study, at week 12, and at the time of a response of the tumor to therapy or at the end of treatment, if treatment ends at week 18 or later. - Additional biopsies, if requested. (Additional biopsies are not required.) - Other procedures, such as computed tomography (CT) or magnetic resonance imaging (MRI) scans, if medically indicated. Patients may continue bevacizumab therapy indefinitely if they are benefiting from it, as long as they have no substantial toxicity or other conditions that would cause them to stop receiving it and the protocol remains open.

NCT ID: NCT00055185 Completed - HIV Infections Clinical Trials

Safety and Efficacy of PRO 542 in the Treatment of HIV-Infected Patients

Start date: April 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine any adverse effects of PRO 542 after administration and to determine the anti-HIV effects of PRO 542 in the patient.

NCT ID: NCT00055120 Completed - HIV Infections Clinical Trials

When to Start Anti-HIV Drugs in Patients With Opportunistic Infections

Start date: March 2003
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV infected patients who are being treated for opportunistic infections (OIs). This study will follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from the OI.

NCT ID: NCT00055107 Completed - HIV Infections Clinical Trials

Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

Cryptosporidium parvum (C. parvum) is a parasite that can cause chronic diarrhea and is a significant problem for HIV infected children in developing countries. C. parvum infection can be treated with the drug nitazoxanide (NTZ). However, NTZ has not been tested in HIV infected children. The purpose of this study is to test the safety of NTZ in HIV infected children who have chronic diarrhea caused by C. parvum. Study hypothesis: Twice-daily NTZ is safe and well tolerated in HIV infected infants, children, and adolescents with chronic diarrhea caused by C. parvum infection.

NCT ID: NCT00055094 Completed - HIV Infections Clinical Trials

Treatment of Acute HIV Infection to Preserve Immune Function

Start date: July 1999
Phase: N/A
Study type: Observational

While most people with HIV experience significant destruction of their immune systems, some people appear to have preserved immune function and can control the virus without drugs. Early treatment with anti-HIV drugs may help preserve the immune system, allowing it to control the virus once the drugs are stopped. This study will evaluate the immune system response of HIV infected people who are treated with anti-HIV drugs soon after being infected.

NCT ID: NCT00054860 Completed - HIV Infections Clinical Trials

Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Uninfected Adults

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety of an HIV DNA vaccine (EP HIV-1090) and to test whether or not the vaccine can stimulate immune system responses in HIV uninfected people. This vaccine uses only parts of the virus's DNA and cannot cause HIV infection.

NCT ID: NCT00054769 Completed - HIV Infections Clinical Trials

Diagnosing Tuberculosis in HIV Infected Children in Peru

Start date: March 2002
Phase: N/A
Study type: Observational

Tuberculosis is a major cause of mortality among AIDS patients in the developing world. The diagnosis of tuberculosis in HIV infected children is complicated by inefficient and expensive tuberculosis tests and vague diagnostic criteria. This study will evaluate the accuracy and efficiency of several different tuberculosis tests that could be used in developing countries.

NCT ID: NCT00054743 Completed - HIV Infection Clinical Trials

Differences in Blood Levels of Nevirapine in HIV-infected Patients in Uganda and the United States

Start date: February 6, 2003
Phase: Phase 4
Study type: Interventional

This study will determine whether blood levels of the anti-HIV medicine nevirapine are different in HIV-infected patients in the United States from patients in Uganda. People from all over the world take medications to treat HIV infection. These medicines work well in some people but not in others, and they cause harmful side effects in some people and not in others. These differences may be related to variations in how much of the drug reaches the blood. Differences in drug blood levels among people in various areas of the world may be attributed to differences in diet, state of health, ability to absorb the medicines from the stomach, ability to eliminate the drugs from the body, and the brand of medicine taken. This study will help scientists learn whether differences in blood levels of HIV medicines are important in determining how well the drugs work in different patient populations. HIV-infected patients 18 years of age and older in the United States and in Kampala, Uganda who have been on an antiretroviral treatment regimen that includes at least 28 consecutive days of nevirapine may be eligible for this study. Candidates will be screened with a medical history, physical examination, and blood tests. Participants will have a total of approximately about 5 ounces of blood drawn during this 6- to 8-hour study. They will come to the NIH clinic in the morning, and a catheter (plastic tube) will be inserted into an arm vein for collecting blood. (Alternatively, blood can be collected by a needle inserted into an arm vein.) Blood will be withdrawn according to the following schedule: - About 5 tablespoons will be collected upon arrival at the clinic after an overnight fast. Within 30 minutes of this blood draw, the patient will have breakfast and take his or her morning dose of nevirapine, along with any other medications that need to be taken at that time. - 1 tablespoon of blood will be drawn 2 hours after the nevirapine dose. - 1 tablespoon of blood will be drawn 4 hours later (6 hours after the nevirapine dose). The blood will be analyzed for levels of nevirapine and possibly other HIV medicines. Some of the blood will be stored for later analysis of genes (cytochrome P450 and MDR1) that are involved in eliminating medicines from the body.