Immediate Versus Deferred Start of Anti-HIV Therapy in HIV-Infected Adults Being Treated for Tuberculosis

PHASE4CompletedINTERVENTIONAL
Enrollment

809

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
HIV InfectionTuberculosis
Interventions
OTHER

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.

OTHER

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.

Trial Locations (26)

4011

CAPRISA eThekwini CRS (31422), Durban

10016

NY Univ. HIV/AIDS CRS (401), New York

20200

Walter Reed Project - Kenya Med. Research Institute Kericho CRS (12501), Kericho

21045

Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro

30100

AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS (12601), Eldoret

50202

Chiang Mai University ACTG CRS (11501), Chiang Mai

92103

University of California, San Diego, AVRC CRS (701), San Diego

94110

University of California, San Francisco AIDS CRS (801), San Francisco

411026

National AIDS Research Institute Pune CRS (11601), Pune

9043010

Hospital Nossa Senhora da Conceicao CRS (12201), Porto Alegre

90033-1079

University of Southern California (1201), Los Angeles

Unknown

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

HT-6110

Les Centres GHESKIO CRS (30022), Bicentenaire

18 PE

Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301), Lima

4013 SF

Durban Adult HIV CRS (11201), Durban

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK

NCT00108862 - Immediate Versus Deferred Start of Anti-HIV Therapy in HIV-Infected Adults Being Treated for Tuberculosis | Biotech Hunter | Biotech Hunter