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NCT ID: NCT01209754 Completed - Pregnancy Related Clinical Trials

EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure)

EMBRACE
Start date: October 1, 2009
Phase:
Study type: Observational

The Prevention Agent Pregnancy Exposure Registry, also known as EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) is a prospective observational cohort investigation of exposures to study agents under investigation for HIV prevention. The study population will consist of female participants who are identified as becoming pregnant during their participation in a microbicide or PrEP trial, or who have had planned exposures in pregnancy safety studies as well as their babies resulting from these pregnancies. This study will only enroll babies who have not yet reached their 1 year birth date.

NCT ID: NCT01066858 Completed - HIV Infections Clinical Trials

Study of Effects of Tenofovir on Bone Health and Kidneys During Pregnancy and Breastfeeding

Start date: March 22, 2011
Phase:
Study type: Observational

The purpose of this study is to look at the effects of tenofovir disoproxil fumarate (an anti-HIV medication) on the bone health and kidneys of women with HIV during pregnancy and while breastfeeding. The study will also look at the changes in overall health, bone health and how the kidneys work in the infants of these women.

NCT ID: NCT01061151 Completed - HIV Infections Clinical Trials

Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries

PROMISE
Start date: March 1, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study was to examine, in an integrated and comprehensive fashion, three critical questions currently facing HIV-infected pregnant and postpartum women and their infants: 1. What is the optimal intervention for the prevention of antepartum and intrapartum transmission of HIV? 2. What is the optimal intervention for the prevention of postpartum transmission in breastfeeding (BF) infants? 3. What is the optimal intervention for the preservation of maternal health after the risk period for prevention of mother-to-child-transmission ends (either at delivery or cessation of BF)? The overall PROMISE protocol had three separate interventional components to address each of these three questions and was conducted at locations in Africa and other parts of the world. Due to variations in the standard of care for HIV-infected pregnant and postpartum women and their infants at different sites, not all of these questions were relevant. Therefore, two separate versions of the PROMISE protocol were developed, each containing only the relevant components. The 1077BF protocol was used at sites where the standard method of infant feeding was breastfeeding, whereas the 1077FF protocol was used at sites where the standard method of infant feeding was formula feeding. The analyses were collapsed across the two protocol versions, and therefore the summaries contain the results of the 1077BF and/or the 1077FF protocols.

NCT ID: NCT00988039 Completed - HIV Clinical Trials

Europe-Africa Research Network for Evaluation of Second-line Therapy

EARNEST
Start date: March 2010
Phase: Phase 3
Study type: Interventional

The trial aim is to ascertain what, if anything, needs to be combined with a boosted protease inhibitor (bPI) backbone in second-line therapy in order to maximize the chance of a good clinical outcome following WHO-defined failure on a first-line nucleoside reverse transcriptase inhibitor (NRTI) and NNRTI-containing regimen with probable extensive NRTI and NNRTI resistance mutations.

NCT ID: NCT00966849 Completed - Education Clinical Trials

Manicaland Cash Transfer Trial for Children in Zimbabwe

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

The purpose of this study is to determine whether cash transfers (conditional and unconditional) can improve health and social outcomes amongst children living in vulnerable households in Manicaland, eastern Zimbabwe. The study hypotheses are: 1. Cash transfers will increase the percentage of vulnerable children aged 0-4 years with a birth certificate. 2. Cash transfers will increase the percentage of vulnerable children aged 0-4 years with up-to-date vaccinations. 3. Cash transfers will increase the percentage of vulnerable children aged 6-12 years attending primary school at least 80% of days per month.

NCT ID: NCT00885703 Completed - HIV Infections Clinical Trials

High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals

Start date: April 16, 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Cryptococcal meningitis (CM) is an infection of the membranes covering the brain and spinal cord, caused by the fungus Cryptococcus neoformans. CM most often affects people with compromised immune systems, like those with advanced HIV infection. This study explored the safety, tolerability, and therapeutic effect of a new treatment regimen with high-dose fluconazole for management of CM in HIV-infected patients.

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: NCT00834457 Completed - Clinical trials for AIDS-related Kaposi's Sarcoma

A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe

Start date: June 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Open-label study of a regimen of antiretrovirals for the treatment of AIDS-KS. This study will be conducted at a single site, the Parirenyatwa Hospital KS Clinic. Step 1 was conducted to determine the extent of clinical resolution of AIDS-KS disease in response to treatment with antiretroviral therapy and to investigate whether clinical resolution of KS is associated with suppression of KSHV replication. Step 2 was developed to then evaluate the clinical, immunological, and virological effects of a switch from a twice-daily all-nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral regimen to a once-daily regimen of 2 NRTIs plus a ritonavir-boosted protease inhibitor in persons with AIDS-KS and good virologic suppression an all NRTI regimen. Step 3 was included to evaluate the clinical, immunological, and virological effects of intensification with a ritonavir-boosted protease inhibitor in persons with AIDS-KS who have virological failure on an all NRTI regimen.

NCT ID: NCT00830856 Completed - HIV Infections Clinical Trials

Early Versus Delayed Antiretroviral Therapy (ART) in the Treatment of Cryptococcal Meningitis in Africa

Start date: October 2006
Phase: N/A
Study type: Interventional

Cryptococcal Meningitis continues to be one of the most devastating AIDS defining illness in sub-Saharan Africa. Despite the availability of azoles such as fluconazole for treatment, mortality remains high with some studies showing 100% mortality. The investigators designed a study to determine if timing of the initiation of antiretroviral therapy (ART) in patients with cryptococcal meningitis and HIV would improve survival. The investigators hypothesis was that early initiation of ART result in improved mortality for patients with HIV and cryptococcal meningitis.