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Clinical Trials/NCT01772940
NCT01772940CompletedPhase 4

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

Centre Hospitalier Universitaire Saint Pierre1 site in 1 country425 target enrollmentStarted: December 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
425
Locations
1
Primary Endpoint
Incidence of therapeutic failure

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: nevirapine (Drug)

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

Intervention: Tenofovir/emtricitabine (Drug)

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

Intervention: ritonavir-boosted Lopinavir (Drug)

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

Intervention: Tenofovir/emtricitabine (Drug)

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

Intervention: nevirapine (Drug)

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

Intervention: Zidovudine/lamivudine (Drug)

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

Intervention: ritonavir-boosted Lopinavir (Drug)

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

Intervention: Zidovudine/lamivudine (Drug)

Outcomes

Primary Outcomes

Incidence of therapeutic failure

Time Frame: At week 48 with follow-up until week 96

The primary end point is the proportion of patients with therapeutic failure defined as: * the occurence or relapse by week 24 of a World Health Organization (WHO) stage 4 or 3 event, or * death by week 24, or * discontinuation of study drugs due to toxicity at any time, or * virological failure defined as HIV-1 RNA \> 1000 copies/ml by week 24

Secondary Outcomes

  • Changes in laboratory parameters(Through week 96)
  • HIV-1 RNA viral load less than 50 copies/ml(Through week 96)
  • Immunologic response(Through week 96)
  • HIV-1 resistance mutations(At baseline and at the time of virologic failure)
  • Safety and tolerability(Through week 96)

Investigators

Sponsor
Centre Hospitalier Universitaire Saint Pierre
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Clumeck Nathan

Chief infectious diseases , Professor of Medicine

Centre Hospitalier Universitaire Saint Pierre

Study Sites (1)

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