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HIV Infections clinical trials

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NCT ID: NCT00924898 Completed - HIV Infections Clinical Trials

Treatment of Acute HIV With Emtricitabine, Tenofovir and Efavirenz (CID 0805)

Start date: January 2005
Phase: Phase 4
Study type: Interventional

This is a pilot study of treatment of acute HIV infection with a once daily regimen of Emtricitabine, Tenofovir and Efavirenz. The primary objectives of this study are: 1. To determine the safety and tolerability, and the virologic and immunologic efficacy of FTC, TDF, and efavirenz given once daily to patients with acute HIV infection. 2. To assess the impact of once daily therapy combined with a standardized adherence program on treatment adherence, virologic suppression, and rate of viral load decline in blood and infectious fluids (semen, cervico-vaginal secretions). 3. To define the prevalence of genotypic and phenotypic resistance to antiretroviral agents among persons diagnosed with acute HIV infection in the Southeastern United States.

NCT ID: NCT00924365 Completed - HIV Infections Clinical Trials

Natural History Study of HIV Acquired in Infancy or Childhood

Start date: February 1, 2007
Phase:
Study type: Observational

Background: - About 10,000 children in the United States have been living with HIV infection since birth. Little is known about the long-term effects of HIV infection and its treatment on the growth and development of these children. - Because of their disease, many children with HIV face additional difficulties with their health, well-being and development, such as success in school and peer relationships. Objectives: - To better understand how HIV infection and the medicines used to treat it affect the growth and development of children, adolescents and young adults who have been infected since birth or when they were very young. - To develop ways to improve the quality of life for these individuals. Eligibility: -HIV-infected patients who were followed by the pediatric HIV program in NCI as of December 2004, or an HIV-infected sibling of a participant. Design: - Periodic evaluation of pubertal development; bone mineralization; body composition and fat distribution; liver, kidney and heart status; and behavioral, cognitive and academic or vocational outcome of the study group. Evaluations include the following: - Physical examinations, including height and weight measurements and skin-fold thickness testing to measure body fat. - Review of medical records and family history. - Blood and urine tests, including pregnancy test in females who can bear children. - DEXA scans (X-ray test to measure bone strength and how much fat, muscle and bone is in the body). - Neuropsychological testing, including evaluation of language, thinking and problem-solving abilities. - Magnetic resonance imaging (MRI): Test using a magnetic field and radio waves to examine brain structure and function. - Oral glucose tolerance test: Blood sampling before and one time after the subject drinks a sugary solution to measure the body's ability to use sugar

NCT ID: NCT00921557 Completed - HIV Infection Clinical Trials

Safety and Effectiveness of Alendronate for Bone Mineral Density in HIV-infected Children and Adolescents

Start date: November 2009
Phase: Phase 2
Study type: Interventional

HIV-infected children, youth, and adults have lower bone mineral density (BMD) than would be expected for HIV-uninfected people of similar age, weight and race. As the majority of perinatally HIV-infected U.S. children are entering or in adolescence, the potential for HIV-related impaired BMD during the adolescent peak of bone mass acquisition is of particular concern. The primary purpose of this study was to compare changes from pre-treatment levels of BMD of the lumbar spine after 24 and 48 weeks of alendronate treatment with placebo in HIV-infected children and adolescents.

NCT ID: NCT00920426 Completed - Clinical trials for Infection, Human Immunodeficiency Virus

Study to Compare the Safety and Anti-HIV Effect of GSK1265744 Versus Placebo in HIV-1 Infected Adults (ITZ112929)

Start date: June 9, 2009
Phase: Phase 2
Study type: Interventional

The purpose of this randomized, double-blinded study is to test the safety of GSK1265744 and how well it works on reducing the amount of HIV in the blood. It will also look at how people react to and how a human body uses GSK1265744. This study will compare the effects of GSK1265744 and placebo. The study will consist of 1 or 2 parts to look at doses of GSK1265744. About 8 people will take part in Part 1 of the study receiving dose A. If additional dosing information is needed after Part 1, about 6 people will take part in Part 2 of the study receiving dose B.

NCT ID: NCT00920296 Completed - Healthy Subjects Clinical Trials

DDI Study of Etravirine and GSK1265744

Start date: July 2009
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to compare steady-state plasma PK, safety and tolerability of GSK1265744 with and without etravirine

NCT ID: NCT00920088 Completed - Healthy Subjects Clinical Trials

Drug Interaction Study of Darunavir/Ritonavir and Lopinavir/Ritonavir on GSK2248761 PK and CYP450 Probe Drugs

Start date: June 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of GSK2448761 on CYP450 metabolic probes and to evaluate the 2-way interaction between GSK2448761 and two ritonavir-boosted protease inhibitors that are commonly used in HIV-infected subjects.

NCT ID: NCT00919854 Completed - Clinical trials for Human Immunodeficiency Virus 1

A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children

Start date: September 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication), safety and antiviral activity to support dose recommendations by body weight of darunavir with low-dose ritonavir (DRV/rtv), in combination with other antiretroviral drugs (ARVs), in treatment-experienced Human immunodeficiency virus 1 (HIV 1) infected children.

NCT ID: NCT00918307 Completed - HIV Infections Clinical Trials

Efficacy and Safety of Varenicline Among HIV-infected Patients

Inter-ACTIV
Start date: October 2009
Phase: Phase 3
Study type: Interventional

Cigarette smoking is a major cause of illness among HIV-infected patients (non-AIDS defining malignancies (especially lung cancer), non-AIDS bacterial infections and cardio-vascular diseases). Approximately 50% of HIV-infected patients are regular tobacco smokers. Tobacco smoking cessation has well known benefits on mortality and morbidity in the general population where tobacco cessation assistance programs are increasingly implemented. However, smoking cessation interventions have never been evaluated among HIV-infected patients. This trial aims at evaluating the efficacy and safety of varenicline for smoking cessation compared with placebo.

NCT ID: NCT00918073 Completed - HIV Infections Clinical Trials

Evaluation of Cardiovascular Effects of Smoking Cessation in HIV Patients

Start date: November 2007
Phase: N/A
Study type: Observational

We will conduct a sub-study of "An Innovative Telephone Intervention for HIV+ Smokers," (NCT00502827) conducted by Drs. Gritz, Vidrine, and others. This is a randomized, prospective trial that will evaluate a cellular phone delivered counseling intervention versus standard of care for smoking cessation. In our sub-study, we will evaluate rates of progression in atherosclerosis in HIV/AIDS patients who quit smoking versus those who continue smoking by measuring carotid intima-media thickness(CIMT) and biomarkers of atherosclerosis at time point baseline, 1 year, and 3 year. The biomarkers measured include high-sensitivity Creactive protein, homocysteine, and IL-6. We will also evaluate rates of progression of CIMT in those who quit smoking versus those who continue smoking, based on race, sex, state of HIV disease, comorbid diseases, and lipid profile.

NCT ID: NCT00917904 Completed - Healthy Clinical Trials

An Expanded Safety Study of Dapivirine Gel 4789 in Africa

Start date: July 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether dapivirine gel 4789 is safe for daily use by healthy women in South Africa.