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

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.

Conditions

• Tuberculosis
• Latent Tuberculosis Infection
• HIV Infections

Interventions

DRUG

isoniazid

A self-administered daily dose of 5mg/kg of Isoniazid or placebo for 12months(300mg if weight is more than or equal to 50kg and 200mg if weight is less than 50kg)

DRUG

Placebo

A self-administered dose of 5mg/kg of placebo (300mg if weight is more than or equal to 50kg and 200mg if weight is less than 50kg)

Sponsors & Collaborators

• Medecins Sans Frontieres, Netherlands

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• University of Cape Town

  lead OTHER

Principal Investigators

• Gary Maartens (overall PI), FCP · University of Cape Town

• Eric Goemaere (co-investigator), MBBS · Medecins Sans Frontieres, Netherlands

• Molebogeng X Rangaka (Lead Investigator), MBChB · University of Cape Town

• Gilles van Cutsem co-investigator), MBBS · Medecins Sans Frontieres, Netherlands

• Andrew Boulle co-investigator), FCP · University of Cape Town

• Robert J Wilkinson (PI:Immunology Studies), FRCP · Wellcome Trust

• Shahied Mathee (Ubuntu PMO), MBChB · Provincial Government of Western Cape

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-11-30

Primary Completion

2011-11-30

Completion

2011-11-30

Countries

• South Africa

Study Locations