IMPAACT

P2026: Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs during Pregnancy and Postpartum

Post Date: 
2021-05-18
   |   
Countries: 
Brazil
India
Malawi
South Africa
Thailand
Uganda
United States
Zimbabwe
   |   
Clinical Sites: 
BJGMC
IMPAACT P1026s, the predecessor of this study, was first approved in 2003. P1026s enrolled over 1000 pregnant/postpartum women, studied the PK of more than 25 HIV and TB drugs in these women and published 27 manuscripts presenting these data. P1026s data was cited in 32% of the 76 perinatal…

A5300B/I2003B: Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx)

Post Date: 
2019-08-19
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Dr. Amita Gupta is Protocol Co-chair for this multinational clinical trial. BACKGROUND The World Health Organization (WHO) estimates that there were 480,000 incident cases of MDR-TB globally in 2015. MDR-TB has been shown to be almost twice as common in TB patients living with HIV compared with TB…

A5300B/I2003B: Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx)

Post Date: 
2019-08-19
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Dr. Amita Gupta is Protocol Co-chair for this multinational clinical trial. BACKGROUND The World Health Organization (WHO) estimates that there were 480,000 incident cases of MDR-TB globally in 2015. MDR-TB has been shown to be almost twice as common in TB patients living with HIV compared with TB…

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
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
This study was terminated September 2, 2021 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…

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
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
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
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
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…

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
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
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…

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
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
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…

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

Post Date: 
2010-02-02
   |   
Countries: 
India
This trial was terminated November 6, 2019. 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…

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

Post Date: 
2010-02-02
   |   
Countries: 
India
This trial was terminated November 6, 2019. 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…

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
   |   
Countries: 
India
South Africa
Uganda
Zimbabwe
   |   
Clinical Sites: 
BJGMC
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…

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
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
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…

Trends and gender differences in access to HIV care with scale up of national HIV treatment guidelines in India

Post Date: 
2020-06-24
   |   
Countries: 
India
Publication: 
Journal of the International Association of Providers of AIDS Care
Test and treat is the current global standard, yet sex differences persist in access to HIV care. We assessed the differences in presentation and antiretroviral therapy (ART) uptake by sex and ART-eligibility period among ART-naive adults registered at a public ART center in India. Four ART…

Isoniazid preventive therapy in HIV-infected pregnant and postpartum women

Post Date: 
2019-10-03
   |   
Countries: 
Botswana
Haiti
India
South Africa
Tanzania
Thailand
Uganda
Zimbabwe
   |   
Clinical Sites: 
BJGMC
Publication: 
New England Journal of Medicine
New England Journal of Medicine: Dr. Amita Gupta and colleagues found that the current standard of care given to HIV+ pregnant women to prevent TB should wait until 12 weeks after delivery. The study underscores the need to include pregnant women in clinical trials.

Vitamin D status and risk of incident tuberculosis disease: A nested case-control study, systematic review, and individual-participant data meta-analysis

Post Date: 
2019-09-11
Publication: 
PLoS Medicine
Background: Few studies have evaluated the association between preexisting vitamin D deficiency and incident tuberculosis (TB). We assessed the impact of baseline vitamins D levels on TB disease risk. Methods and findings: We assessed the association between baseline vitamin D and incident TB in a…

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
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Publication: 
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
   |   
Countries: 
India
Publication: 
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
   |   
Countries: 
India
Publication: 
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:…

Risk Factors for Hepatotoxicity in HIV-infected Women Receiving Isoniazid preventive Therapy in Pregnancy and Postpartum

Post Date: 
2020-07-08
Gupta A, Aaron L, Theron G, McCarthy K, Bradford S, Chipato T,

Prevalence and Incidence of Tuberculosis Infection and Disease Among Household Contacts Exposed to Rifampin-resistant/Multidrug resistant Tuberculosis (RR/MDR-TB)

Post Date: 
2020-07-08
Gupta A, Wu X, Kim S, Naini L, Hughes M, Dawson R, Gaikwad S, Sanchez J, Mendoza A, Smith B, Shah S, Hesseling A, Churchyard G, Swindells S for the ACTG/IMPAACT PHOENIx feasibility study team. Prevalence and Incidence of Tuberculosis Infection and Disease Among Household Contacts Exposed to…

Adjusted analysis of effect of IPT on adverse pregnancy outcomes in women with HIV

Post Date: 
2020-03-09
   |   
Clinical Sites: 
BJGMC
Theron G , Chakhtoura N, Montepiedra G, Aaron L, Jean-Phillipe P, Weinberg A, McCarthy K, Nematadzira T, Masheto G, Chipato T, Onyango-Makumbi C, Gupta A, the IMPAACTP1078 Team. Adjusted analysis of effect of IPT on adverse pregnancy outcomes in women with HIV. Presented at: CROI 2020. Boston,…

Resistance to Mycobacterium tuberculosis infection among household contacts of MDR TB patients

Post Date: 
2019-10-31
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Baliashvili D , Gandhi NR, Kim S, Gupta A, Churchyard G, Swindells S, Hesseling A, Hughes M, Shah S for the ACTG 5300/IMPAACT I2003 PHOENIx Feasibility Study Team. Resistance to Mycobacterium tuberculosis infection among household contacts of MDR TB patients. Poster presentation. 50th Union World…

High prevalence of tuberculosis infection in children living in households of MDR-TB patients

Post Date: 
2019-10-31
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Kim S , Wu X, Hughes M, Mendoza-Ticona A, Churchyard G, Swindells S, Shah NS, Gupta A, Hesseling A for the A5300/I2003 PHOENIx Feasibility Study Team. High prevalence of tuberculosis infection in children living in households of MDR-TB patients. Short oral presentation. 50th Union World Conference…

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…