Randomised controlled trial of isoniazid preventive therapy in South African adults with advanced HIV disease
METHODS: We conducted a randomised, double-blind, controlled trial comparing isoniazid (INH) with placebo among TST-negative adults with World Health Organization Stage 3 or 4 HIV disease. INH/placebo was administered for 12 months by patient-nominated supervisors. TST-positive participants were given open-label INH. Participants, who did not have access to antiretroviral therapy (ART), were followed up for 24 months with 6-monthly sputum culture and chest radiography.
RESULTS: A total of 118 participants were enrolled: TST was negative in 98. In the randomised arms, the incidence of TB was 18/100 person-years (py) in the INH arm and 11.6/100 py in the placebo arm (hazard ratio 1.59, 95%CI 0.57–4.49). There were no significant differences in mortality, hospitalisation rate or CD4+ lymphocyte decline. INH/placebo adherence was 85%, and was significantly higher among participants with work-based treatment supervisors.
CONCLUSIONS: We did not find any association between INH preventive therapy and reductions in incident TB among TST-negative adults with advanced HIV disease, but the study had limited statistical power. High levels of adherence were observed with patient-nominated supervisors.
Document Type: Regular Paper
Affiliations: 1: HIV/AIDS Unit, Cape Peninsula University of Technology, Cape Town, South Africa; School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa 2: School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa 3: Desmond Tutu HIV Centre, Institute of Infectious Diseases & Molecular Medicine, University of Cape Town, Cape Town, South Africa 4: Department of Physiology, University of Stellenbosch, Cape Town, South Africa 5: Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa
Publication date: 2007-10-01
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