Overview

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

Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Hospitalier Universitaire Saint Pierre
Collaborators:
Abbott
Gilead Sciences
Ministry of Public Health, Democratic Republic of the Congo
Pierre and Marie Curie University
University Hospital of Liege
University of Liege
University Paris 7 - Denis Diderot
Treatments:
Emtricitabine
Lamivudine
Lopinavir
Nevirapine
Ritonavir
Tenofovir
Zidovudine
Criteria
Inclusion Criteria:

- Antiretroviral-therapy naïve HIV-1 infected Adults

- WHO clinical stage 3 and CD4 <350/mm3 or

- WHO clinical stage 4 or

- CD4 cell count < 200/mm3

- Negative pregnancy test

Exclusion Criteria:

- Hemoglobin < 8.5 g/dL (female) or 9.0 g/dL (male)

- Estimated Glomerular Filtration Rate < 50 ml/ minute (Cockcroft-Gault equation)

- Hepatic transaminases (AST and ALT)> 3 x upper limit of normal

- Active tuberculosis

- Pregnancy

- Females who are breastfeeding