Clinical trialNCT00084136CompletedPhase 4Interventional

Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings

SponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsEnrollment1,571HIV Infections

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study compared 3 different three-drug combinations in HIV infected individuals starting their first HIV treatment regimens. Participants were recruited from resource-limited areas in Africa, Asia, South America, Haiti, and also from the United States. The study hypothesis was each of the once daily combinations (PI based, or NNRTI based) would not have inferior efficacy compared to the twice daily NNRTI based combination.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

James Hakim, MscClinEpi, FRCP
Department of Medicine, University of Zimbabwe
Study Chair
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Nagalingeswaran Kumarasamy, MD
Centre for AIDS Research and Education
Study Chair
clinicaltrials.gov ↗
Thomas B. Campbell, MD
University of Colorado, Denver
Study Chair
clinicaltrials.gov ↗
Timothy Flanigan, MD
The Miriam Hospital
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

42 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Brazil

Hospital Nossa Senhora Da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Pesquisa Clinica Evandro Chagas (ipec) Crs
Manguinhos, Rio de Janeiro, Brazil

Haiti

Les Centres Gheskio Crs
Bicentenaire, Port-au-Prince, Haiti

India

Yrg Care Medical Ctr., Vhs Chennai Crs
Rajiv Gandhi Salai Taramani, Chennai, India
Nari Pune Crs
Pune, Maharashtra, India
Nari Clinic at Niv Crs
Maharashtra State, Pune, India
Dr. Kotnis Dispensary
Pune, India

Malawi

College of Med. Jhu Crs
P.O. Box 1131, Blantyre, Malawi
University of North Carolina Lilongwe Crs
Mzimba Road, Lilongwe, Malawi

Peru

Asociacion Civil Impacta Salud Y Educacion - Miraf Crs
Barranco, Lima region, Peru
San Miguel Crs
San Miguel, Lima region, Peru

South Africa

Wits Hiv Crs
Johannesburg, Gauteng, South Africa
Durban Adult Hiv Crs
Durban, KwaZulu-Natal, South Africa

Thailand

Chiang Mai Univ. Actg Crs
P.O. Box 80, Chiang Mai, Thailand

United States

Ucla Care Center Crs
Los Angeles, California, United States
University of Southern California
Los Angeles, California, United States
Harbor General/ucla
Torrance, California, United States
Univ. of Colorado Health Sciences Center, Denver
Denver, Colorado, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States
Cook County Hospital Core Center
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Rush-Presbyterian/st. Lukes (chicago)
Chicago, Illinois, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University (st. Louis)
St Louis, Missouri, United States
Hiv Prevention & Treatment Crs
HVTN 722 West 168th Street MSPH Bldg., New York, United States
Beth Israel Medical Center
New York, New York, United States
Cornell Crs
New York, New York, United States
Ny Univ. Hiv/aids Crs
New York, New York, United States
Community Health Network, Inc.
Rochester, New York, United States
Univ. of Rochester Actg Crs
Rochester, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Wake County Health and Human Services Clinical Research Site
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
the Ohio State Univ. Aids Crs
Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania Crs
Philadelphia, Pennsylvania, United States
Stanley Street Treatment and Resource
Providence, Rhode Island, United States
the Miriam Hosp. Actg Crs
Providence, Rhode Island, United States
Vanderbilt Therapeutics Crs
Nashville, Tennessee, United States
University of Texas, Southwestern Medical Center
Dallas, Texas, United States

2 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Atazanavir →DidanosineEfavirenz →Emtricitabine →Lamivudine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 May 2005
Primary completion: 31 May 2010
Completion: 31 May 2010
Last update posted: 10 Oct 2018
Registered enrollment: 1,571
Registry id: NCT00084136

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.