IMPAACT

P2010: Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants “VESTED”

Post Date: 
2019-02-06
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Full Title: P2010: Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants “VESTED”: V irologic E fficacy and S afety of ART Combinations with T AF/TDF, E FV, and D...

P2005: A Phase I/II Open-Label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination with OBR for MDR-TB in HIV-Infected and Uninfected Children with MDR-TB

Post Date: 
2018-06-07
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New study will characterize the pharmacokinetics of delamanid using a model-based approach, and evaluate safety and tolerability of over 24 weeks of study treatment in HIV infected and uninfected children.

A5300/IMPAACT2003: Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design

Post Date: 
2015-09-01
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This clinical trial was terminated July 18, 2017. It was a study conducted under both the AIDS Clinical Trial Group (ACTG) and the the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network, and funded by the U.S. National Institutes of Health. Dr. Amita Gupta was...

P1078: A Phase IV Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety of Immediate (Antepartum-Initiated) Versus Deferred (Postpartum-Initiated) Isoniazid Preventive Therapy Among HIV-Infected Women in High TB Incidence Settings

Post Date: 
2014-04-01
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This is a clinical trial conducted under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S. National Institutes of Health. Dr. Amita Gupta is Protocol Chair for this multinational clinical trial being conducted in Botswana, Haiti, South...

P1073: Study of Immune Reconstitution Inflammatory Syndrome (IRIS) for International Sites Initiating Highly Active Antiretroviral Therapy (HAART) in Infants and Children < 72 Months of Age

Post Date: 
2010-11-15
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This study was terminated April 23, 2015. This was a multi-national study conducted in India, South Africa, and Tanzania under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S. National Institutes of Health. P1073 is a case controlled...

P1077BF: Breastfeeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)

Post Date: 
2010-02-02
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This multi-country trial is being conducted in India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe, conducted under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S. National Institutes of Health.. 1077BF is a randomized...

P1077FF: Formula Feeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)

Post Date: 
2010-02-02
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This multi-country trial is being conducted in India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe, under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S. National Institutes of Health. 1077FF is a randomized strategy...

P1070: Dose-Finding and Pharmacogenetic Study of Efavirenz in HIV-Infected and HIV/TB Co-Infected Infants and Children ≥ 3 Months to < 36 Months of Age

Post Date: 
2008-12-05
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This study ended March 10, 2015. This multi-country trial was conducted in India, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe, under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S. National Institutes of Health. Efavirenz (EFV)...

P1060: Phase II, parallel, randomized, clinical trials comparing the responses to initiation of NNRTI-based antiretroviral therapy in HIV-infected infants who have not previously received Single dose Nevirapine for prevention of Mother-to-child HIV...

Post Date: 
2006-03-27
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This study ended June 28, 2015. This multi-country trial was conducted in India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S. National Institutes of Health. Full Title...

Inclusion of key populations in clinical trials of new antituberculosis treatments: Current barriers and recommendations for pregnant and lactating women, children, and HIV-infected persons

Post Date: 
2019-08-15
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PLOS Medicine
PLOS Medicine: Dr. Amita Gupta and colleagues discuss the scientific and ethical basis for including pregnant and lactation women, children, and HIV+ patients in tuberculosis therapeutic clinical trials.

Willingness to take multidrug-resistant tuberculosis (MDR-TB) preventive therapy among Adult and adolescent household contacts of MDR-TB index cases: an international multi-site cross-sectional study

Post Date: 
2019-03-28
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Clinical Infectious Diseases
Abstract BACKGROUND: Household contacts (HHCs) of individuals with multidrug-resistant tuberculosis (MDR-TB) are at high risk of infection and subsequent disease. There is limited evidence on the willingness of MDR-TB HHCs to take MDR-TB preventive therapy (TPT) to decrease their risk of TB disease...

Maternal health outcomes among HIV-infected breastfeeding women with high CD4 counts: results of a treatment strategy trial

Post Date: 
2019-03-20
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HIV Clinical Trials
BACKGROUND: IMPAACT PROMISE 1077BF/FF was a randomized study of antiretroviral therapy (ART) strategies for pregnant and postpartum women with high CD4+ T-cell counts. We describe postpartum outcomes for women in the study who were randomized to continue or discontinue ART after delivery. METHODS:...

Pregnancy is associated with decreased serum isoniazid levels in women living with HIV

Post Date: 
2019-03-07
Gausi K , Denti P, Weisner L, Wallis C, Onyango-Makumbi C, Chipato T, Theron G, Bradford S, Costello D, Browning R, Chakhtoura N, Weinberg A, Montepiedra G, Gupta A and the IMPAACT P1078 (TB APPRISE) Study Group Team. Pregnancy is associated with decreased serum isoniazid levels in women living...