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Evaluation of the Efficacy and Safety Between Two Antiretroviral Regimens, in HIV-1-infected Treatment-naïve Subjects With Low CD4 Counts

NCT01928407 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-01-12

No results posted yet for this study

Summary

A phase IV, prospective, multicenter , randomized open label, 48 weeks study to evaluate the antiretroviral efficacy and safety of atazanavir/ritonavir or darunavir/ritonavir, each in combination with a fixed dose of tenofovir disoproxil fumarate- emtricitabine in HIV-1-infected treatment-naïve subjects with CD4 counts below 200 µL.

Conditions

  • HIV-1 Infection
  • Immunosuppression-related Infectious Disease

Interventions

DRUG

DARUNAVIR

The patient included will receive their first antiretroviral regimen included the darunavir treatment in combination with 2 others molecules

DRUG

ATAZANAVIR

The patient included will receive their first antiretroviral regimen included the atazanavir treatment in combination with 2 others molecules

Sponsors & Collaborators

  • Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

    lead OTHER

Principal Investigators

  • Laurence LS SLAMA, PhD · Hospital TENON

  • Roland RL LANDMAN, PhD · Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-23
Primary Completion
2011-03-29
Completion
2013-01-07

Countries

  • France

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 NCT01928407 on ClinicalTrials.gov