Study name : A Strategy Study of Immediate Versus Deferred Initiation of Antiretroviral Therapy for AIDS Disease-Free Survival in HIV-Infected Persons Treated for Tuberculosis with CD4 < 250 cells/mm3
Research network (Code) : A5221
Principle investigator : Professor Khuanchai Supparatpinyo, MD
Funding agency : The National Institute of Allergy and Infectious Diseases
Study sites: There are 9 U.S. sites and 22 Non-U.S. Site
U.S.:
New York University Bellevue
University of California Los Angeles, Harbor
University of California San Diego
University of California San Francisco
University of Southern California
Bronx-Lebanon
Houston AIDS Research Team
New Jersey Medical School
Terry Beirn Community Programs for Clinical Research
Non-U.S.:
University of Witswatersrand, Johannesburg, SOUTH AFRICA
Durban Adult HIV CRS, Durban, SOUTH AFRICA
Asociacion Civil Impacta Salud y Educacion, Miraflores, Lima, PERU
INMENSA, Lince, Lima, PERU
Les Centres GHESKIO, Port-au-Prince, HAITI
Chiang Mai University, Chiang Mai, THAILAND
NARI, Pune, INDIA
YRG Care, Chennai, INDIA
University of North Carolina, Lilongwe, MALAWI
Evandro Chagas, FioCruz, Rio de Janeiro, BRAZIL
Hospital Nossa Senhora de Canceicao, Porto Alegre, BRAZIL
Chris Hani Baragwanath Hospital, Soweto, SOUTH AFRICA
JCRC, Kampala, UGANDA
Walter Reed Project, Kericho, KENYA
AMPATH (MOI University), Eldoret, KENYA
Gaborone Prevention/Treatment Trials, Gaborone, BOTSWANA
Molepolole Prevention/Treatment Trials, Molepolole, BOTSWANA
Kalingalinga Clinic, Lusaka, ZAMBIA
Johns Hopkins University Research Project, Blantyre, MALAWI
University of Zimbabwe Parirentyatwa, Harare, ZIMBABWE
Projeto PRACA ONZE/HEFSA, Rio de Janeiro, BRAZIL
CAPRISA eThekwini, Durban, SOUTH AFRICA
Study start :
RIHES-CMU started enrollment in October 2008
Study design: An open-lable randomized controlled trial to compare outcome between immediate ART and deferred ART among HIV positive TB patients.
Study objectives
To compare the proportion of participants in the immediate ART arm versus the deferred ART arm surviving without AIDS progression (defined as a new AIDS-defining illness) at week 48.
Significance : The results of this study will help determine the ART treatment strategy in HIV positive TB patients.
Progression
The study was closed on 25 September 2009, as the target number of participants has been achieved. The follow up is expected to end at the end of July 2010.
