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HIV Infections clinical trials

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NCT ID: NCT00050180 Completed - Healthy Clinical Trials

Influence of the MDR1 Genotype on Blood Levels of Indinavir and Saquinavir in Healthy Volunteers

Start date: November 22, 2002
Phase: Phase 4
Study type: Interventional

This study will examine whether a particular type of gene (MDR1) in the body can affect blood levels of two protease inhibitors, indinavir and saquinavir, which are used to treat people with HIV. If blood levels of these drugs are too low or too high, they may not work well or may cause side effects in patients. This study will determine how MDR1 genes might affect absorption of these medicines. Healthy normal volunteers between 18 and 50 years of age may be eligible for this study. Candidates will be screened with a medical history and blood and urine tests. The blood will be tested for: - Routine laboratory values for assessing general health - HIV - MDR1 gene type - Amount of P-glycoprotein (a protein made by the MDR1 gene) on T cells. Participants will have blood drawn three more times, as follows: - After one dose of the sedative midazolam (Versed(Registered Trademark)): Participants will take an 8-milligram dose of midazolam syrup by mouth. Four hours later, a single blood sample will be drawn through a needle in an arm vein. This part of the study will assess the efficiency of a certain enzyme involved in metabolizing (breaking down) indinavir and saquinavir. - After four doses of indinavir: About a week after taking the midazolam, participants will take 800 mg of indinavir (two capsules) 3 times a day (every 8 hours) for 1 day. The following morning they will come to the clinic, where a catheter (flexible plastic tube) will be placed in an arm vein for repeated blood draws. A blood sample will be drawn, and a fourth and final dose of indinavir will be given. Seven blood samples of about a teaspoon each will then be collected through the catheter over an 8-hour period to measure blood levels of the drug. - After 10 doses of saquinavir: About a week after the last dose of indinavir, participants will start taking 1,200 mg (6 capsules) of saquinavir soft-gelatin capsules 3 times a day for 3 days. On the fourth day, participants will come to the clinic. A catheter will be inserted into an arm vein and about 4 teaspoons of blood will be collected for routine laboratory tests and to measure saquinavir levels. A urine sample will also be collected for routine tests. Participants will then receive the tenth and final dose of saquinavir, and eight blood samples of about a teaspoon each will be collected through the catheter over an 8-hour period.

NCT ID: NCT00050089 Completed - HIV Infections Clinical Trials

CSP #512 - Options in Management With Anti-Retrovirals

OPTIMA
Start date: January 2001
Phase: N/A
Study type: Interventional

This 'pragmatic' trial is a 2X2 open randomized study of patients in advanced HIV disease who have failed on conventional Highly Active Antiretroviral Therapy (HAART) regimens including all three classes of anti-HIV drugs. The first randomization will allocate patients to an intended 3-month antiretroviral drug-free period (ARDFP) or No ARDFP. The second randomization will allocate patients to Mega-ART (5+ drugs) or to Standard-ART (up to 4 drugs). The total study duration is 6.5 years with 5 years of intake and 1.5 year (minimum) of follow-up; median duration of patient follow-up is about 4 years. The target sample size is 390 patients and will provide 75% power to detect a 30% reduction in the hazard rate for the primary endpoint with mega-ART. Sixty-four sites will be participating in the trial--24 VA, 19 UK and 21 Canada.

NCT ID: NCT00050063 Completed - HIV Infections Clinical Trials

Effects of Therapeutic HIV Vaccination on Control of HIV After Discontinuation of Anti-HIV Drugs

Start date: n/a
Phase:
Study type: Observational

The purpose of this study is to determine whether therapeutic HIV vaccines can help the immune system control HIV viral load after anti-HIV drugs are discontinued.

NCT ID: NCT00048282 Completed - HIV Infections Clinical Trials

HIV Prevention Preparedness Study

Start date: n/a
Phase: N/A
Study type: Observational

The purpose of this study is to provide researchers with information that will help them prepare for a future study to test the efficacy of two anti-HIV vaginal gels. This study will also estimate how likely people living in certain areas are to become infected with HIV and other infections passed during sex.

NCT ID: NCT00048217 Active, not recruiting - HIV Infections Clinical Trials

A Rollover Study to Provide Chronic T-1249 to Patients Who Completed Study T1249-102

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

Patients who complete study T1249-102 (must be currently failing a T-20 containing regimen to participate in this study) will receive T-1249 at a dose of 200mg daily in combination with a background antiretroviral regimen for 96 weeks. Only patients that participated in study T1249-102 can participate in study T1249-105.

NCT ID: NCT00046722 Completed - HIV Infections Clinical Trials

Marijuana for HIV-Related Peripheral Neuropathy

Start date: January 2003
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate whether smoked marijuana reduces pain in people with HIV-related peripheral neuropathy.

NCT ID: NCT00046436 Terminated - HIV Infections Clinical Trials

Rapid HIV Tests for Women Late in Pregnancy and During Labor

Start date: n/a
Phase: N/A
Study type: Observational

This study will look at how well the OraQuick HIV 1/2 Antibody rapid test works and how women accept being tested for HIV late in pregnancy and during labor. For women with positive test results, the study will look at whether or not these women accept anti-HIV drugs and which drugs they receive.

NCT ID: NCT00046345 No longer available - HIV Infections Clinical Trials

Atazanavir for HIV Infected Individuals: An Early Access Program

Start date: May 2002
Phase: N/A
Study type: Expanded Access

The purpose of this clinical research study is to provide atazanavir to patients infected with human immunodeficiency virus (HIV) whose antiviral medications are no longer working to control HIV activity within the body and who are unable to create a new treatment regimen using other available anti-HIV drugs, because of either side effects or treatment failure previously taken. The safety of this treatment will also be studied.

NCT ID: NCT00046332 Completed - HIV Infections Clinical Trials

A Study Comparing 4 Doses Of GW810781 Versus Placebo In HIV-Infected Patients

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

This study will evaluate the drop in viral load over 10 days of treatment with S-1360 versus placebo in HIV-infected patients who have not previously taken anti-HIV medications.

NCT ID: NCT00046280 Active, not recruiting - HIV Infections Clinical Trials

Multicenter AIDS Cohort Study (MACS)

Start date: April 1984
Phase:
Study type: Observational

This is a comprehensive observational study of HIV infection in homosexual and bisexual men.