Isoniazid Preventive Therapy in HIV-Infected Pregnant and Postpartum Women.

ABSTRACT:

Background

The safety, efficacy, and appropriate timing of isoniazid therapy to prevent tuberculosis in pregnant women with human immunodeficiency virus (HIV) infection who are receiving antiretroviral therapy are unknown.

Methods

In this multicenter, double-blind, placebo-controlled, noninferiority trial, we randomly assigned pregnant women with HIV infection to receive isoniazid preventive therapy for 28 weeks, initiated either during pregnancy (immediate group) or at week 12 after delivery (deferred group). Mothers and infants were followed through week 48 after delivery. The primary outcome was a composite of treatment-related maternal adverse events of grade 3 or higher or permanent discontinuation of the trial regimen because of toxic effects. The noninferiority margin

SUBMITTER: Gupta A 

PROVIDER: S-EPMC7051859 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature