809
Participants
Start Date
August 31, 2006
Primary Completion Date
July 31, 2010
Study Completion Date
July 31, 2010
Strategy: Immediate ART
The intervention is the strategy of initiating antiretroviral therapy (ART) after approximately 2 weeks of rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided ART is efavirenz (EFV) 600 mg (1 tablet orally), emtricitabine (FTC) 200 mg (1 capsule orally), and tenofovir disoproxil fumarate (TDF) 300 mg (1 tablet orally) daily. Substitutions with other locally available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals that are compatible with TB treatment may be used at the discretion of the site investigator. The TB treatment will be supplied and monitored by the host country TB control program.
Strategy: Deferred ART
The intervention is the strategy of initiating ART either after 8-12 weeks of RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided ART is EFV 600 mg (1 tablet orally), FTC 200 mg (1 capsule orally), and TDF 300 mg (1 tablet orally) daily. Initiation outside of these windows, on a case by case basis, is permitted at the discretion of the site investigator. Substitutions with other locally available U.S. FDA-approved or tentatively approved antiretrovirals that are compatible with TB treatment may be used at the discretion of the site investigator. The TB treatment will be supplied and monitored by the host country TB control program.
CAPRISA eThekwini CRS (31422), Durban
NY Univ. HIV/AIDS CRS (401), New York
Walter Reed Project - Kenya Med. Research Institute Kericho CRS (12501), Kericho
Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro
AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS (12601), Eldoret
Chiang Mai University ACTG CRS (11501), Chiang Mai
University of California, San Diego, AVRC CRS (701), San Diego
University of California, San Francisco AIDS CRS (801), San Francisco
National AIDS Research Institute Pune CRS (11601), Pune
Hospital Nossa Senhora da Conceicao CRS (12201), Porto Alegre
University of Southern California (1201), Los Angeles
Gaborone Prevention/Treatment Trials CRS (12701), Gaborone
Molepolole Prevention/Treatment Trials CRS (12702), Molepolole
Projecto Praca Onze/Hesfa CRS (30333), Rio de Janeiro
Y.R.G Ctr, for AIDS Research and Education (11701), Chennai
College of Med. JHU CRS (30301), Blantyre
University of North Carolina Lilongwe CRS (12001), Lilongwe
Investigaciones Medicas en Salud (INMENSA) (11302), San Isidro
Soweto ACTG CRS (12301), Johannesburg
Univ. of Witwatersrand CRS (11101), Johannesburg
Joint Clinical Research Centre (JCRC) (12401), Kampala
Kalingalinga Clinic CRS (12801), Lusaka
UZ-Parirenyatwa CRS (30313), Harare
Les Centres GHESKIO CRS (30022), Bicentenaire
Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301), Lima
Durban Adult HIV CRS (11201), Durban
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK