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HIV Infections clinical trials

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NCT ID: NCT00089518 Withdrawn - HIV Infections Clinical Trials

Optimal Treatment for Kidney Disease in HIV Infected Adults

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

The angiotensin receptor blocker (ARB) valsartan is a drug commonly used to treat high blood pressure. Valsartan may also help slow down the progression of kidney disease in HIV infected people. The purpose of this study is to compare valsartan and antiretroviral therapy (ART) to ART alone in slowing kidney disease progression in people with HIV.

NCT ID: NCT00089505 Completed - HIV Infections Clinical Trials

NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission

OCTANE
Start date: November 2006
Phase: Phase 3
Study type: Interventional

Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are commonly included in anti-HIV drug regimens. However, HIV infected women who have previously taken the single dose NNRTI nevirapine (SD NVP) for the prevention of mother-to-child transmission (MTCT) of HIV may not respond as well to NNRTIs as women who have never taken NVP. Another class of anti-HIV drugs, protease inhibitors (PIs), may be more effective for women who have previously taken NNRTIs. This study will compare the effectiveness of NNRTI- and PI-based regimens in women who have taken NVP for prevention of MTCT of HIV. This study will also compare regimens including an NNRTI with regimens including a PI in women who have never taken NVP.

NCT ID: NCT00089492 Completed - HIV Infections Clinical Trials

A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients

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

This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by the treating physician. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00089466 Completed - HIV Infections Clinical Trials

Safety and Activity of the Oral HIV Entry Inhibitor AMD11070 in HIV Infected Patients

Start date: November 2004
Phase: Phase 1/Phase 2
Study type: Interventional

New treatment options are critical for treatment-experienced HIV infected patients with drug resistance. HIV entry inhibitors have been shown effective in patients with resistance to other anti-HIV drugs. This study will test the safety and anti-HIV activity of eight different doses of the HIV entry inhibitor AMD11070 (also known as AMD070) in HIV infected patients.

NCT ID: NCT00088309 Completed - HIV Infections Clinical Trials

Effect of Tenofovir DF on Bone Metabolism in Children

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

This study will examine the long-term effects, particularly on bone metabolism, of the drug tenofovir DF in children with HIV infection. Tenofovir DF is approved for treating HIV-infected adults, but its use in children has not yet been approved. The drug may be helpful for children who have been treated with many other drugs and still have detectable HIV in their blood despite ongoing therapy. In a previous study, many children given tenofovir DF responded well, with increases in T-cell counts and decreases in viral load. However, many children also experienced bone thinning. This study will explore the problem of bone thinning in children taking tenofovir DF in combination with highly active antiretroviral therapy (HAART). HIV-infected patients from 4 to 20 years old who are taking tenofovir DF or for whom tenofovir DF treatment has been recommended may be eligible for this 3-year study. Participants take tenofovir DF every day in addition to their antiretroviral therapy. They have frequent follow-up visits for tests and procedures as follows: - Study days 0, 2, and 4: blood tests. - Screening and every study visit starting day 6: Physical exam, medical history, blood and urine tests. - Baseline and every 48 weeks: Dental and eye examinations, kidney ultrasound, tuberculin skin testing, chest x-ray, electrocardiogram and echocardiogram, computed tomography (CT) scan, neuropsychological testing and neurologic assessment. - The bone age hand x-rays are done every 24 weeks, unless the growth plates are fused (i.e. the child has stopped growing) - DEXAs are done at 0, 12, 24 weeks and every 24 weeks thereafter. Dual energy x-ray absorptionometry (DEXA) scan is used to assess bone density. The patient lies still on a table while the spine and hip are scanned using a small amount of radiation. Only the spine and hip are scanned in the DEXA scan test. - Baseline and week 24: Optional bone biopsy. Some patients are asked to undergo a bone biopsy to better understand the effect of Tenofovir DF on bone. For the procedure, the child is given a sedative. The skin over the hipbone is numbed with a small needle, a small incision is made and a larger needle is inserted into the bone. Some of the bone tissue is withdrawn through the needle and the incision is closed. - Possible lumbar puncture (spinal tap): This optional procedure analyzes cerebrospinal fluid (CSF), the fluid that bathes the brain and spinal cord. The patient is given a local anesthetic and a needle is inserted into the space between the bones in the lower back where the CSF circulates below the spinal cord. A small amount of fluid is collected through the needle. There is no specific schedule for this procedure if the patient opts for it. Patients who are benefiting from tenofovir DF therapy but show signs of bone effects are offered treatment with pamidronate (Aredia), a drug used to treat hypercalcemia (too much calcium in the blood). Patients who stop taking tenofovir DF because of bone toxicity continue to be followed on the regular study schedule. Those who stop the drug for toxicity other than bone toxicity or for toxicity not related to tenofovir DF are followed every 4 weeks until their laboratory test results improve.

NCT ID: NCT00087945 Completed - HIV Infections Clinical Trials

Blood Levels of Abacavir in HIV Infected Adolescents

Start date: July 2004
Phase: N/A
Study type: Interventional

The way abacavir (ABC) behaves in the body differs between children and adults, but little is known about ABC in adolescents. It is unclear if adult doses of ABC are appropriate for adolescents. The purpose of this study is to determine the blood levels of ABC in HIV infected adolescents who are on ABC-containing regimens.

NCT ID: NCT00087464 Withdrawn - HIV Infections Clinical Trials

Three Month Course of Anti-HIV Medications for People Recently Infected With HIV

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

Short-term therapy may reduce the amount of HIV in the blood of adults recently infected with HIV. The purpose of this study is to see whether it is better for people to take a short course of anti-HIV drugs when they are first infected or if it is better to wait until the HIV infection causes health problems before taking anti-HIV drugs.

NCT ID: NCT00086710 Completed - HIV Infections Clinical Trials

Study of Enfuvirtide in HIV-Positive Subjects

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

A total of 26 patients will be admitted to the clinic where they will be dosed with each injection device. There will be a 7-day washout between doses and a 7-10 day follow-up period.

NCT ID: NCT00086372 Completed - HIV Infections Clinical Trials

Long-term Follow-up of HIV Infected Patients Identified During Early Infection

Start date: July 2003
Phase: N/A
Study type: Observational

This is a long-term follow-up study of people who are identified during acute or recent HIV infection and are being followed at clinical research sites associated with the Acute HIV Infection and Early Disease Research Program (AIEDRP).

NCT ID: NCT00086359 Completed - HIV Infections Clinical Trials

Comparison of Anti-HIV Drug Combinations to Prevent Mother-to-Child Transmission of HIV

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

Pregnant women infected with HIV who take anti-HIV medications during pregnancy lower the risk of passing HIV to their infants. This study will compare how well two different combinations of anti-HIV medications control HIV in pregnancy, and whether these combinations of drugs are effective in preventing HIV from being transmitted from a pregnant woman to her baby. The two combinations are abacavir/lamivudine/zidovudine (ABC/3TC/ZDV) and zidovudine/lamivudine (ZDV/3TC) plus lopinavir/ritonavir (LPV/RTV).