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Nevirapine vs Ritonavir-boosted Lopinavir in ART Naive HIV-infected Adults in a Resource Limited Setting

NCT01772940 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 425

Last updated 2013-08-26

No results posted yet for this study

Summary

In resource-limited setting, concerns remain regarding the emergence of virologic failure and high-level drug resistance mutations (DRM) during WHO recommended first-line antiretroviral therapy (ART) with non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens for Human immunodeficiency virus 1 (HIV1) infected patients. The study hypothesis is that a boosted-protease inhibitor regimen has a better outcome than a NNRTI-based regimen with a low genetic barrier to resistance.

The study is a randomized, multicenter, factorial trial (conducted in Congo), in treatment- naïve adults receiving for 96 weeks ritonavir- boosted lopinavir(LPV/r) or nevirapine (NVP) each in combination with tenofovir (TDF) /emtricitabine (FTC) or zidovudine (ZDV)/lamivudine (3TC). The primary end point is the incidence of therapeutic (clinical and/or virologic)failure by study week 24.

Conditions

  • HIV-1 Infection

Interventions

DRUG

nevirapine

Nevirapine 200 mg twice daily or 400 mg once daily per os during 96 weeks

DRUG

ritonavir-boosted Lopinavir

ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily per os during 96 weeks

DRUG

Tenofovir/emtricitabine

tenofovir 300 mg/emtricitabine 200 mg fixed-dose combination once daily, per os for 96 weeks

DRUG

Zidovudine/lamivudine

zidovudine 300 mg/lamivudine 150 mg twice daily fixed-dose generic combination, per os for 96 weeks

Sponsors & Collaborators

  • University of Liege

    collaborator OTHER

  • Ministry of Public Health, Democratic Republic of the Congo

    collaborator OTHER_GOV

  • Pierre and Marie Curie University

    collaborator OTHER

  • University Paris 7 - Denis Diderot

    collaborator OTHER

  • Gilead Sciences

    collaborator INDUSTRY

  • Abbott

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire Saint Pierre

    lead OTHER

Principal Investigators

  • Nathan Clumeck, MD, PhD · Centre Hospitalier Universitaire Saint Pierre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-10-31
Completion
2011-12-31

Countries

  • Republic of the Congo

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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 NCT01772940 on ClinicalTrials.gov