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NCT ID: NCT00955968 Completed - HIV Infection Clinical Trials

IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women

Start date: January 1, 2010
Phase: Phase 4
Study type: Interventional

This study was a randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but did not otherwise meet criteria to initiate HAART for their own health. The study was designed to determine whether continuation of HAART after delivery or other pregnancy outcome reduced morbidity and mortality compared to discontinuation and re-initiation of HAART when protocol specified criteria were met.

NCT ID: NCT00905489 Completed - HIV Infections Clinical Trials

A Phase I Multiple Dose Pharmacokinetic Study of Nevirapine Extended Release (XR) in HIV-1 Infected Children.

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

The primary objective is to establish the pharmacokinetic (PK) profile at steady state of nevirapine XR in HIV infected children from >=3 to <18 years of age. This phase I trial is an open-label, multiple dose, non-randomized and cross-over study. Patients who have completed the last visit of the PK trial (visit 7) can enter into an Optional Extension Phase (OEP) until the Investigational New Drug (IND) is withdrawn; until nevirapine XR becomes approved and is available by prescription in a given country; or, the patient enrolls in a compassionate use program. During this OEP, nevirapine XR safety and efficacy information will be collected.

NCT ID: NCT00880698 Completed - HIV Infection Clinical Trials

Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers

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

Rotavirus is the leading cause of severe diarrhea in infants and young children, accounting for 45% of severe diarrhea disease in both developed and developing countries. Annually, rotavirus causes approximately 111 million episodes of gastroenteritis requiring home care, 25 million clinic visits, 2 million hospitalizations, and approximately 440,000 deaths in children less than 5 years of age, of which approximately 90% of hospitalizations and 99% of deaths occur in developing countries. Although rotavirus infection is not more common in HIV-infected children, it complicates their care and interferes with their nutrition. Chances of death by these infections can be greater in HIV-infected children when they also suffer from wasting, malnutrition, and/or opportunistic infections. The primary purpose of this study was to evaluate the safety and immunogenicity of the Rotavirus vaccine candidate, RotaTeq, in HIV-infected and uninfected children born to HIV-infected mothers.

NCT ID: NCT00865826 Completed - HIV Infections Clinical Trials

Observational Study of Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals

Start date: December 2009
Phase: N/A
Study type: Observational

An estimated 3 million HIV-infected individuals will enter programs for antiretroviral (ARV) treatment in the coming year, with projected rates of requirement for ARV therapy extending to more than 10 million in sub-Saharan Africa, southeastern Asia, and Latin America in the coming decade. In these settings, Tuberculosis (TB) is an endemic infection in the population, and an estimated 30-60% of adults have been infected with TB, the leading opportunistic infection associated with HIV infection. The purpose of this study is to construct a standardized diagnostic evaluation (SDE) for TB that provides an increase in identification of participants with active pulmonary TB, without sacrificing specificity.

NCT ID: NCT00840905 Completed - HIV Infections Clinical Trials

A Study to Examine the Human Papillomavirus Types Exposure in Women From Southern Africa and Brasil

Start date: February 2009
Phase: N/A
Study type: Observational

This is a study to determine what Human Papillomavirus HIV seropositive women in Botswana, South Africa and Brasil have been exposed to during their life. The Human Papillomavirus causes cervical cancer. Different types are more likely to lead to cancer than other types. A vaccine has been made to fight infection against HPV 16 and 18 which has been shown to cause cervical cancer in America and Europe. What HPV type cause cancer in other countries is not as well studied. Hypothesis HPV serology will demonstrate that exposure to each HPV type in Gardisil (6,11,16,18) will be <50% in HIV seropositive women in resource limited countries.

NCT ID: NCT00608569 Completed - HIV Infections Clinical Trials

Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults

Start date: March 2009
Phase: N/A
Study type: Interventional

Highly active antiretroviral therapy (HAART) has led to better health and survival rates among people with HIV/AIDS. The purpose of this study was to measure the effect of trained partner supervision when taking medication versus self-administered therapy in HIV infected participants. These participants have had their first virologic failure on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART regimen and were starting a protease inhibitor (PI)-based HAART regimen at study entry.

NCT ID: NCT00561925 Completed - HIV Infections Clinical Trials

VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients

Start date: November 2007
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients after 48 weeks of treatment. Secondary objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR.

NCT ID: NCT00485264 Completed - HIV Infections Clinical Trials

Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents

Start date: September 17, 2007
Phase: Phase 1/Phase 2
Study type: Interventional

Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral replication. Raltegravir is a drug that prevents integrase from working properly. This drug has been tested for safety and efficacy in adults, but this is the first study to examine raltegravir in children and adolescents. The purpose of this study was to determine the appropriate dose for raltegravir across the pediatric age range from 4 weeks to 18 years of age, by acquiring short and long term safety data, intensive and population pharmacokinetic (PK) data, and efficacy experience with raltegravir in HIV-infected children and adolescents.

NCT ID: NCT00448669 Completed - HIV Infections Clinical Trials

Botswana TDF/FTC Oral HIV Prophylaxis Trial

TDF2
Start date: March 2007
Phase: Phase 2/Phase 3
Study type: Interventional

This study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral medicines) was safe for sexually-active young adults in Botswana without HIV infection and whether it reduced their risk of getting an HIV infection.

NCT ID: NCT00385554 Withdrawn - HIV Infections Clinical Trials

Botswana Study of UC-781 Vaginal Microbicide

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

This study will test the safety, side effects, and acceptability of two strengths of UC-781 gel when used by women and men in Botswana for two weeks.