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HIV Infections clinical trials

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NCT ID: NCT00736502 Completed - HIV Infections Clinical Trials

PMS Assessing the Long-term Efficacy and Safety of Nevirapine Therapy (Combined With Other ARV Drugs) in HIV-1 Positive Patients in Daily Clinical Practice.

Start date: September 2008
Phase: N/A
Study type: Observational

The aim of this trial is to evaluate the safety and virological and immunological efficacy of Viramune® on a background of different antiretroviral drug combinations.

NCT ID: NCT00736242 Completed - HIV Infections Clinical Trials

Post-marketing Surveillance of HIV-infected Patients With Chronic Hepatitis C Treated With PegIntron Pen and Rebetol (Study P04584)

Start date: December 2005
Phase: N/A
Study type: Observational

The objective of the study was to assess the safety and efficacy of peginterferon alfa-2b (PEG-IFN alfa-2b) and ribavirin (RBV) administered to participants coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). Participants were treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study assessed the rates of eradication of the HCV and the rates of serious adverse events reported with PEG-IFN alfa-2b (1.5 ug/kg/week) and RBV (800-1200 mg/day) in common medical practice in Germany.

NCT ID: NCT00735072 Completed - HIV Infection Clinical Trials

Maraviroc as an Immunomodulatory Drug for Antiretroviral-treated HIV Infected Patients Exhibiting Immunologic Failure

Start date: September 2008
Phase: Phase 4
Study type: Interventional

Many people with HIV fail to regain normal CD4 counts despite effectively suppressing HIV replication with medications. Blocking the "co-receptor" for HIV might decrease inflammation of the immune system, potentially providing an immune benefit. The goal of the current trial is to determine whether adding maraviroc, a new CCR5 "co-receptor" blocker, decreases inflammation, providing an immune benefit for patients with low CD4 counts despite undetectable viral loads on HIV medications. In this study, HIV-infected patients who are receiving antiretroviral therapy for HIV will receive either maraviroc or a placebo (sugar pill) each day for 24 weeks. After 24 weeks, the study medication will be stopped and all subjects will be followed for 12 more weeks. Blood tests measuring the extent of inflammation, low-level viremia, and immune function will be measured throughout the trial and compared between treatment arms.

NCT ID: NCT00730223 Completed - HIV Infections Clinical Trials

Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors

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

To see if certain variations in the CYP2B6 gene contribute to differences in plasma drug levels and central nervous system side affects in people who take nevirapine or efavirenz.

NCT ID: NCT00729924 Completed - HIV Infections Clinical Trials

Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid

Start date: August 2008
Phase: Phase 2/Phase 3
Study type: Interventional

This study is being done to find out how much of the drug raltegravir (RGV) gets into cerebrospinal fluid (CSF), compared to how much get into the blood and to find out if normal changes in a certain gene in your body affects how much RGV gets into the CSF.

NCT ID: NCT00729573 Completed - HIV Infections Clinical Trials

Bone Mineral Density Substudy - An Ancillary Study to MTN-003

Start date: November 2009
Phase:
Study type: Observational

The MTN-003 HIV prevention study include the use of microbicides, substances that kill microbes, and tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) - oral, FDA-approved, anti-HIV drugs. The purpose of this study is to determine if taking daily TDF and FTC/TDF as a part of the study MTN-003 has an effect on bone mineral density (BMD).

NCT ID: NCT00727597 Completed - Clinical trials for Human Immunodeficiency Virus Infections

A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT

SUPPoRT
Start date: July 2008
Phase: Phase 3
Study type: Interventional

The hope of this study is to gather data and information about the tolerability and effectiveness of Lexiva versus Sustiva in patients who have have been generally underrepresented in clinical trials.

NCT ID: NCT00724178 Completed - HIV Infection Clinical Trials

The Effect of Vitamin D and Calcium on Bone in Pediatric HIV

Start date: July 2003
Phase: Phase 2/Phase 3
Study type: Interventional

We have observed that vitamin D deficiency, as evidenced by low serum 25(OH)D concentrations, is common in children and adolescents with HIV infection. To determine whether vitamin D and calcium supplementation improve bone mineral content (BMC) and bone mineral density (BMD) in HIV-infected children and adolescents, we propose a double-blind, randomized, placebo-controlled trial comparing supplementation with oral vitamin D and calcium to placebo. The specific aims of this project are to: 1. Determine the effect of vitamin D and calcium supplementation on bone mineral accrual in HIV-infected children. We hypothesize that BMC and BMD will increase to a greater extent in HIV-infected children who receive supplementation with vitamin D and calcium. This hypothesis will be tested by comparing changes in BMC and BMD, measured by dual energy x-ray absorptiometry (DXA), after one and two years of treatment in HIV-infected children and adolescents receiving vitamin D and calcium supplementation compared to those receiving placebo. 2. Determine the effect of HIV infection and vitamin D and calcium supplementation on indices of mineral metabolism and markers of bone turnover. We hypothesize that indices of mineral metabolism and markers of bone formation and resorption will return toward normal in HIV-infected children and adolescents who are randomized to receive vitamin D and calcium supplementation. We will test these hypotheses by comparing longitudinal changes in indices of mineral metabolism and bone turnover markers in HIV-infected children and adolescents receiving vitamin D and calcium supplement versus those receiving placebo 3. Evaluate if vitamin D stores are a determinant of bone mass in HIV infected children and adolescents receiving HAART. We hypothesize that vitamin D stores, as assessed by serum 25-hydroxyvitamin D levels, are an important determinant of bone mass in HIV-infected children and adolescents receiving HAART. We will test this hypothesis by evaluating whether measurements of bone mass are associated with vitamin D stores, as measured by serum 25-hydroxyvitamin D levels and other indices of mineral metabolism, in treated HAART-treated HIV-infected children and adolescents.

NCT ID: NCT00723775 Completed - Clinical trials for Infection, Human Immunodeficiency Virus

GSK706769/KALETRA Drug-drug Interaction Study

Start date: July 24, 2008
Phase: Phase 1
Study type: Interventional

To compare plasma GSK706769 PK following repeat administration of GSK706769 QD with and without KALETRA (LPV 400 mg/RTV 100mg) q12h

NCT ID: NCT00723476 Completed - HIV Infections Clinical Trials

Family Centered Advanced Care Planning for Adolescents With HIV/AIDS and Their Families

Start date: September 2005
Phase: N/A
Study type: Interventional

This study will examine the efficacy of Family Centered Advance Care Planning in enhancing quality of life, integrating effective end-of-life care, and preventing depression and anxiety among HIV infected adolescents and their family members.