Immediate Versus Deferred Start of Anti-HIV Therapy in HIV-Infected Adults Being Treated for Tuberculosis
Completed · Phase 4
Conditions studied: HIV Infection, Tuberculosis
In brief
The purpose of this study is to determine the best time to begin anti-HIV treatment in individuals who have HIV and tuberculosis (TB). Study hypothesis: Immediate antiretroviral therapy (ART), initiated after approximately 2 weeks of TB treatment, will reduce the frequency of other AIDS-defining illnesses and death in HIV-infected participants being treated for TB by at least 40% at week 48 when compared to deferred ART, initiated at after 8-12 weeks of TB treatment.
Key facts
- Study ID
- NCT00108862
- Run by
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- People needed
- 809
- Starts
- 2006-08-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2018-10-11
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- HIV-infected.
- Confirmed or probable TB (more information on the criterion can be found in the protocol).
- Chest x-ray within 30 days prior to study entry.
- Receipt of 1-14 cumulative days of rifampin- or other rifamycin-based TB treatment that was initiated within 28 days prior to study entry.
- CD4 count less than 250 cells/mm\^3 within 30 days prior to study entry.
- Willing to use acceptable methods of contraception while on study drugs and for 6 weeks after stopping these drugs.
- Able to swallow oral medications.
- Parent of guardian willing to provide informed consent, if applicable.
- Karnofsky performance score =>20 at time of study entry.
You may not qualify if…
- ART for longer than 7 cumulative days prior to study entry or treatment for any period of time with one or more antiretrovirals. Participants who have taken ART during pregnancy or for occupational exposure are not excluded.
- Allergy or sensitivity to any of the study drugs or their formulations.
- History of multidrug-resistant TB.
- Receipt of any investigational therapy or chemotherapy within 30 days prior to study entry.
- Certain medications.
- Breastfeeding.
Where it is running
- University of Southern California (1201) — Los Angeles, California, United States
- University of California, San Diego, AVRC CRS (701) — San Diego, California, United States
- University of California, San Francisco AIDS CRS (801) — San Francisco, California, United States
- NY Univ. HIV/AIDS CRS (401) — New York, New York, United States
- Gaborone Prevention/Treatment Trials CRS (12701) — Gaborone, Botswana
- Molepolole Prevention/Treatment Trials CRS (12702) — Molepolole, Botswana
- Hospital Nossa Senhora da Conceicao CRS (12201) — Porto Alegre, Rio Grande do Sul, Brazil
- Instituto de Pesquisa Clinica Evandro Chagas (12101) — Rio de Janeiro, Brazil
- Projecto Praca Onze/Hesfa CRS (30333) — Rio de Janeiro, Brazil
- Les Centres GHESKIO CRS (30022) — Bicentenaire, Port-au-Prince, Haiti
- National AIDS Research Institute Pune CRS (11601) — Pune, Maharashtra, India
- Y.R.G Ctr, for AIDS Research and Education (11701) — Chennai, India
- AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS (12601) — Eldoret, Kenya
- Walter Reed Project - Kenya Med. Research Institute Kericho CRS (12501) — Kericho, Kenya
- College of Med. JHU CRS (30301) — Blantyre, Malawi
- University of North Carolina Lilongwe CRS (12001) — Lilongwe, Malawi
- Investigaciones Medicas en Salud (INMENSA) (11302) — San Isidro, Lima region, Peru
- Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301) — Lima, Peru
- CAPRISA eThekwini CRS (31422) — Durban, KwaZulu-Natal, South Africa
- Durban Adult HIV CRS (11201) — Durban, South Africa
- Soweto ACTG CRS (12301) — Johannesburg, South Africa
- Univ. of Witwatersrand CRS (11101) — Johannesburg, South Africa
- Chiang Mai University ACTG CRS (11501) — Chiang Mai, Thailand
- Joint Clinical Research Centre (JCRC) (12401) — Kampala, Uganda
- Kalingalinga Clinic CRS (12801) — Lusaka, Zambia
Full record on ClinicalTrials.gov
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