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

Nevirapine vs Ritonavir-boosted Lopinavir in ART HIV-infected Adults in a Resource-limited Setting; a Randomized, Multicenter, Parallel Group Study

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.

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