Trial | NCT01772940  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    425
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.
Study Started
Dec 31
2008
Primary Completion
Oct 31
2011
Study Completion
Dec 31
2011
Last Update
Aug 26
2013
Estimate

Drug nevirapine

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

  • Other names: Viramune

Drug ritonavir-boosted Lopinavir

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

  • Other names: Aluvia

Drug Tenofovir/emtricitabine

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

  • Other names: Truvada

Drug Zidovudine/lamivudine

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

  • Other names: Zidolam,combivir

nevirapine and tenofovir/emtricitabine Active Comparator

nevirapine 200 mg twice daily combined with tenofovir 300 mg/emtricitabine 200 mg (fixed-dose combination) once daily, per os for 96 weeks

lopinavir/r and tenofovir/emtricitabine Experimental

ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily combined with tenofovir 300 mg/emtricitabine 200 mg (fixed-dose combination) once daily, per os for 96 weeks

Nevirapine and zidovudine/lamivudine Active Comparator

nevirapine 200 mg/zidovudine 300 mg/lamivudine 150 mg (fixed-dose combination) twice daily, per os for 96 weeks

Lopinavir/r and zidovudine/lamivudine Experimental

ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg once daily combined with zidovudine 300 mg/lamivudine 150 mg once daily, per os for 96 weeks

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
No Results Posted