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:
Participant gender:
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
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