P1078

A Phase IV Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety (Hepatotoxicity) of Immediate (Antepartum-Initiated) vs. Deferred (Postpartum-Initiated) Isoniazid Preventive Therapy Among HIV-Infected Women in High TB incidence Settings

Sponsors: 
US National Institute of Allergy and Infectious Diseases (NIAID)
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Scientific Collaboration with the Tuberculosis Trials Consortium (TBTC) of the CDC

Protocol Summary:
P1078 is a study of HIV-infected pregnant women and infants born to HIV-infected mothers. The study is designed to compare overall safety and toxicity of immediate versus deferred INH preventive therapy in HIV-infected pregnant women enrolled at ≥14 through ≤ 34 weeks gestation and by HAART strata.

Years: 2014 – present

Investigators: 
Tsungai Chipato, MBChB, FRCOG, MCE
Lynda Stranix-Chibanda, MBChB, MMED
Mutsawashe Bwakura-Dangarembizi, MBChB, MMED, MSc Cli.Epi

Locations: Parirenyatwa, Seke North, and St. Mary’s CRSs

IMPAACT

Current Study

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