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Evaluation of a Lopinavir/Ritonavir Monotherapy vs a Triple Therapy as Maintenance Regimens in HIV-1 Infected Patients

NCT00946595 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2014-06-24

No results posted yet for this study

Summary

A 2-year multicenter, phase II/III, randomized active-controlled trial to evaluate the efficacy and tolerance of two maintenance strategies in HIV-1 infected patients with HIV RNA below 50 copies/mL : a monotherapy with lopinavir/ritonavir or a single-tablet triple therapy (EFV/FTC/TDF).

Conditions

  • HIV Infections

Interventions

DRUG

efavirenz/emtricitabin/tenofovir

1x600/200/245 mg per day (one tablet) between W0 et W98

DRUG

lopinavir/ritonavir

4 x 200/50 mg (4 tablets) once a day between W0 and W98

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Gilead Sciences

    collaborator INDUSTRY

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2013-07-31
Completion
2014-01-31

Countries

  • France

Study Locations

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Entities

Companies

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 NCT00946595 on ClinicalTrials.gov