IMPAACT

Studies/Projects
Publications

Biomarkers of Hepatotoxicity in Pregnant and Postpartum Women Living With HIV and Latent TB

Post Date:

2021-06-21

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Primary objectives: 1. Quantify INH metabolite PK in pregnant and postpartum WLWH receiving IPT, and compare INH metabolites exposures between cases and controls. 1. Identify biomarkers of hepatotoxicity in pregnant and postpartum WLWH receiving IPT. 2. Model relationships between drug metabolite...

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

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2021-05-18

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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

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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...

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

Post Date:

2019-08-19

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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...

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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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 “...

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

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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

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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...

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...

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...

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

Post Date:

2010-02-02

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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)

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2010-02-02

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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

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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...

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...

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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...

Timing of maternal isoniazid preventive therapy on tuberculosis infection among infants exposed to HIV in low-income and middle-income settings: a secondary analysis of the TB APPRISE trial

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2023-09-13

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Lancet Child Adolescent Health

Deferral of maternal isoniazid preventive therapy to early postpartum had no effect on infant tuberculosis acquisition in our trial population, regardless of the diagnostic test used.

Factors associated with prevalent Mycobacterium tuberculosis infection and disease among adolescents and adults exposed to rifampin-resistant tuberculosis in the household

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2023-03-17

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PLOS ONE

Background: Understanding factors associated with prevalent Mycobacterium tuberculosis infection and prevalent TB disease in household contacts of patients with drug-resistant tuberculosis (TB) may be useful for TB program staff conducting contact investigations. Methods: Using data from a cross-...

Prevalence of neurotoxicity symptoms among postpartum women on Isoniazid Preventive Therapy and Efavirenz-based treatment for HIV—An exploratory objective of the IMPAACT P1078 randomized trial

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2022-06-21

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BMC Pregnancy and Childbirth

Background This exploratory analysis investigates the prevalence and risk factors of neurocognitive toxicity in postpartum women on HIV treatment in response to a concern of an Isoniazid Preventive Therapy (IPT)/Efavirenz interaction. Trial Design Pregnant women on HIV treatment from countries with...

High prevalence of TB infection and disease in child household contacts of adults with rifampin-resistant tuberculosis

Post Date:

2022-05-01

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Pediatric Infectious Disease Journal

Background: Household contact (HHC) investigation is an important strategy to identify individuals with tuberculosis (TB) exposure, infection and disease, including those who may benefit from tuberculosis preventive therapy (TPT). Data in children exposed to rifampin-resistant TB are limited...

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

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2020-06-24

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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

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2019-10-03

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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

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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

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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...