NCT01772940

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 425 (actual)
• Sponsor: Centre Hospitalier Universitaire Saint Pierre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-10-01
• Completion: 2011-12-01
• First posted: 2013-01-21
• Last updated: 2013-08-26

Locations

1 site across 1 country: Republic of the Congo