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Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults

NCT00196599 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2005-09-20

No results posted yet for this study

Summary

In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Such therapy induces side effects and the number of pills may reduce therapy adherence. The aim of this study is to evaluate the efficacy and the safety of a once daily FTC, ddI, efavirenz combination, in HIV patients with CD4 cell count over 100/mm3, antiretroviral naive.

Conditions

  • HIV Infections
  • Antiretroviral Naive

Interventions

DRUG

emtricitabine, FTC (drug)

DRUG

didanosine, ddI (drug)

DRUG

efavirenz (drug)

Sponsors & Collaborators

  • Triangle Pharmaceuticals

    collaborator INDUSTRY

  • Gilead Sciences

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Dupont Applied Biosciences

    collaborator INDUSTRY

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • Jean-Michel Molina, MD, PhD · Service de Maladies Infectieuses, Hôpital Saint-Louis, Paris, 75475, France

  • Genevieve Chene, MD, PhD · INSERM unité 593, Bordeaux, France

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-02-28
Completion
2004-09-30

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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 NCT00196599 on ClinicalTrials.gov