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

NCT00084136 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1571

Last updated 2018-10-10

Study results available
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Summary

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.

Conditions

  • HIV Infections

Interventions

DRUG

Atazanavir

400 mg taken orally daily

DRUG

Didanosine (enteric-coated)

400 mg taken orally daily

DRUG

Efavirenz

600 mg taken orally daily

DRUG

Emtricitabine

200 mg taken orally daily

DRUG

Emtricitabine/Tenofovir disoproxil fumarate

200 mg/300 mg taken orally once daily

DRUG

Lamivudine/Zidovudine

150 mg/300 mg taken orally twice daily

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    lead NETWORK

Principal Investigators

  • Thomas B. Campbell, MD · University of Colorado, Denver

  • Timothy Flanigan, MD · The Miriam Hospital

  • James Hakim, MscClinEpi, FRCP · Department of Medicine, University of Zimbabwe

  • Nagalingeswaran Kumarasamy, MD · Centre for AIDS Research and Education

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States
  • Brazil
  • Haiti
  • India
  • Malawi
  • Peru
  • South Africa
  • Thailand
  • Zimbabwe

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00084136 on ClinicalTrials.gov