Journal article
Integration of antiretroviral therapy with tuberculosis treatment
SS Abdool Karim, K Naidoo, A Grobler, N Padayatchi, C Baxter, AL Gray, T Gengiah, S Gengiah, A Naidoo, N Jithoo, G Nair, WM El-Sadr, G Friedland, Q Abdool Karim
New England Journal of Medicine | MASSACHUSETTS MEDICAL SOC | Published : 2011
Abstract
BACKGROUND: We previously reported that integrating antiretroviral therapy (ART) with tuberculosis treatment reduces mortality. However, the timing for the initiation of ART during tuberculosis treatment remains unresolved. METHODS: We conducted a three-group, open-label, randomized, controlled trial in South Africa involving 642 ambulatory patients, all with tuberculosis (confirmed by a positive sputum smear for acid-fast bacilli), human immunodeficiency virus infection, and a CD4+ T-cell count of less than 500 per cubic millimeter. Findings in the earlier-ART group (ART initiated within 4 weeks after the start of tuberculosis treatment, 214 patients) and later-ART group (ART initiated duri..
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Funding Acknowledgements
Supported by the U.S. President's Emergency Plan for AIDS Relief; the Centre for the AIDS Programme of Research in South Africa (CAPRISA); the Global Fund to Fight AIDS, Tuberculosis, and Malaria; and the National Institutes of Health Comprehensive International Program of Research on AIDS.We thank the patients for their participation in this study; Prof. Willem Sturm of the Nelson R. Mandela School of Medicine for confirmatory tuberculosis testing; the management and staff of the Prince Cyril Zulu Communicable Disease Clinic, eThekwini Municipality, for support of the study; Drs. Gray Handley, Ed Tramont, Rod Hoff, Sandi Lehrman, and Richard Hafner of the Division of AIDS at the National Institutes of Health for study support; Drs. Gavin Churchyard, Douglas Taylor, and Mark Weaver for serving on the data and safety monitoring committee; members of the Community Advisory Board for their advice regarding the conduct of the trial; Ms. Nomapando Barnabas of the CAPRISA Community Programme for overseeing community involvement in the trial; Ms. Natasha Samsunder and Mr. Keith Coetzee for laboratory analysis; Ms. Nonhlanhla Yende for statistical support; Ms. Irene van Middelkoop for data management; and all the other members of the SAPIT study team for their commitment to high-quality study conduct.