Nevirapine vs Ritonavir-boosted Lopinavir in ART Naive HIV-infected Adults in a Resource Limited Setting
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.
Timeline
- Start
- 2008-12
- Primary completion
- 2011-10
- Completion
- 2011-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lamivudine | Other / unclassified | 150 mg | Oral |
| Subject | Lopinavir | Other / unclassified | 400 mg | Oral |
| Subject | Lopinavir | Other / unclassified | 800 mg | Oral |
| Comparator | Nevirapine | Small molecule | 200 mg | Oral |
| Comparator | Nevirapine | Small molecule | 400 mg | Oral |
| Subject | Ritonavir | Other / unclassified | 100 mg | Oral |
| Subject | Ritonavir | Other / unclassified | 200 mg | Oral |
| Subject | Tenofovir | Small molecule | 300 mg | Oral |
| Subject | Zidovudine | Small molecule | 300 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 200 mg | Oral |