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HIV Infection clinical trials

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NCT ID: NCT00080119 Terminated - Tuberculosis Clinical Trials

Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV

Start date: February 2004
Phase: Phase 2/Phase 3
Study type: Interventional

Tuberculosis (TB) is highly endemic in sub-Saharan Africa. The increased burden of TB in settings with high prevalence of the Human Immunodeficiency Virus (HIV) is associated with high rates of transmission of Mycobacterium tuberculosis (M.tb) to both adults and children. Children infected with TB have a higher risk of developing severe disease than adults with TB. The purpose of this study was to determine if the antibiotic isoniazid (INH) prevented TB infection in infants born to HIV-infected mothers.

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.

NCT ID: NCT00053638 Completed - HIV Infection Clinical Trials

A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

Start date: February 2003
Phase: Phase 3
Study type: Interventional

This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.

NCT ID: NCT00051519 Completed - HIV Infection Clinical Trials

Screening HIV-Infected Patients for Vaccine Studies

Start date: January 9, 2003
Phase: N/A
Study type: Observational

This screening study will evaluate potential study volunteers with HIV infection to see if they are suitable candidates for trials of experimental vaccines against HIV (therapeutic), and against other infections (preventive). - Preventive vaccines against other infections. Preventive vaccines prevent a person from getting a disease. Preventive vaccines have been developed for many diseases, including, for example, whooping cough, measles, mumps, influenza, and hepatitis B. Some preventive vaccines may also prevent a disease from taking hold if given immediately after infection, such as vaccines for rabies, smallpox and hepatitis. - Therapeutic vaccines against HIV. Therapeutic vaccines are intended to treat someone who has already been infected, with the goal of controlling the disease or preventing it from causing severe illness. As yet, there are no therapeutic vaccines for any diseases. - Vaccines against other infections. Vaccines to prevent other infections besides HIV may need to be tested separately in people with HIV infection because the immune system works differently when HIV infection is present. HIV-infected patients 18 years of age or older may be eligible for this screening study. Women who are pregnant or breast feeding may not participate. Participants will be screened with the following: - A health history, including questions about sexual activity and drug use; - Physical examination, including blood and urine tests; - HIV testing to confirm HIV infection; - Pregnancy test for premenopausal women; - PPD test for tuberculosis for those who have not been tested in the previous 6 months. Candidates who meet the requirements for investigational vaccine studies will be invited to participate in a study. Those who do not begin a study within 1 month of the screening tests may need to repeat some tests for continued consideration. In addition, some studies require repeated measures of CD4 counts and viral load over a period of a few months.

NCT ID: NCT00046176 Completed - HIV Infection Clinical Trials

A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients

Start date: August 26, 2002
Phase: Phase 3
Study type: Interventional

This study is a 48-week study designed to evaluate the safety and efficacy of a fixed-dose combination tablet administered once-a-day versus the individual tablets administered twice-a-day within 3-drug combination regimens in ART (antiretroviral)-experienced HIV-1 infected patients.

NCT ID: NCT00044577 Completed - HIV Infection Clinical Trials

New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects

Start date: July 16, 2002
Phase: Phase 3
Study type: Interventional

A 48-week study to investigate the safety and effectiveness of a new compact formulation of two already FDA-approved anti-HIV drugs in subjects who have already been receiving treatment for their HIV infection.

NCT ID: NCT00040664 Completed - HIV Infection Clinical Trials

A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years

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

This is a 48-week study to collect additional information on the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen (course of therapy) including FDA approved HIV drugs in HIV-infected patients 2 - 18 years old.

NCT ID: NCT00038506 Completed - HIV Infection Clinical Trials

Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure

Start date: March 2002
Phase: Phase 4
Study type: Interventional

This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen.

NCT ID: NCT00035893 Completed - HIV Infection Clinical Trials

The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART

Start date: May 2001
Phase: Phase 2
Study type: Interventional

This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to a Strategic Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA < 50 copies/ml (PCR) and CD4 levels > 400.

NCT ID: NCT00035581 Terminated - HIV Infection Clinical Trials

Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART

Start date: May 2001
Phase: Phase 2
Study type: Interventional

This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to "HAART" in HIV infected patients with CD4 counts >300 and HIV-1 plasma RNA >500 and <30,000 copies/ml (PCR).