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

Study Location:

India

Topic:

HIVHIV PreventionMaternal-Child Health and HIVTuberculosis and HIV

Clinicaltrials.gov Link:

https://clinicaltrials.gov/ct2/show/NCT01253538?term=PROMISE&rank=1

IRB#:

NA_00049859

Coordinator:

Nishi Suryavanshi

Enrollment:

Closed

Trial Period:

Completed

P1078 is a Phase IV, randomized, double-blind, placebo-controlled study of HIV-infected pregnant women and the infants born to the 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.


P1078 Multi-Country Study Team 2016 (Washington DC)

Mother/infant pairs: HIV-infected pregnant women ≥ 14 weeks through ≤ 34 weeks (34 weeks, 6 days) gestation.

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