Isoniazid Plus Antiretroviral Therapy to Prevent Tuberculosis in HIV-infected Persons

Completed 1368 enrolled University of Cape Town Imperial College London · collab Johns Hopkins University · collab London School of Hygiene and Tropical Medicine · collab Medecins Sans Frontieres, Netherlands · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to evaluate whether isoniazid can safely (and further) reduce the risk of tuberculosis in HIV infected people receiving HAART.

Timeline

Start: 2007-11
Primary completion: 2011-11
Completion: 2011-11

Outcome

Met primary endpoint

paper 58 in the placebo group (3·6 per 100 person-years, 2·8-4·7; hazard ratio [HR] 0·63, 95% CI 0·41-0·94). PMID 24835842 ↗

Publications

Rangaka MX, Wilkinson RJ, Boulle A, Glynn JR, Fielding K, van Cutsem G, Wilkinson KA, Goliath R, Mathee S, Goemaere E, Maartens G. Isoniazid plus antiretroviral therapy to prevent tuberculosis: a randomised double-blind, placebo-controlled trial. Lancet. 2014 Aug 23;384(9944):682-90. doi: 10.1016/S0140-6736(14)60162-8. Epub 2014 May 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Isoniazid	Small molecule	5 mg/kg	—