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Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults

NCT00118898 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1864

Last updated 2018-10-12

Study results available
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Summary

Currently, the preferred anti-HIV regimens used in the United States consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and the nonnucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV). However, with new anti-HIV drugs being approved, alternative regimens need to be tested to determine if new drug combinations have increased effectiveness in treating HIV. The purpose of this study is to test the safety, tolerability, and effectiveness of four different regimens in HIV-infected adults who have never taken anti-HIV drugs.

Conditions

  • HIV Infections

Interventions

DRUG

Abacavir/Lamivudine

600 mg abacavir/300 mg lamivudine tablet taken orally daily

DRUG

Atazanavir

300 mg tablet taken orally daily

DRUG

Efavirenz

600 mg tablet taken orally daily

DRUG

Emtricitabine/Tenofovir disoproxil fumarate

200 mg emtricitabine/300 mg tenofovir disoproxil fumarate tablet taken orally daily

DRUG

Ritonavir

100 mg tablet taken orally daily

DRUG

Abacavir/Lamivudine placebo

Placebo tablet taken orally daily

DRUG

Emtricitabine/Tenofovir disoproxil fumarate placebo

Placebo tablet taken orally 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

  • Eric Daar, MD · Harbor-UCLA Medical Center, Los Angeles Biomedical Research Institute

  • Paul Sax, MD · Division of Infectious Diseases, Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States
  • Puerto Rico

Study Locations

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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 NCT00118898 on ClinicalTrials.gov