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Completed

NCT Number: NCT01772940

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

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.

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Key information

Conditions

HIV-1 Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cliniques Universitaires de Lubumbashi

Lubumbashi, Katanga, Republic of the Congo

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nevirapine

Drug

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

Other names: Viramune

Ritonavir-boosted lopinavir

Drug

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

Other names: Aluvia

Tenofovir/Emtricitabine

Drug

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

Other names: Truvada

Zidovudine/Lamivudine

Drug

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

Other names: Zidolam,combivir

Primary outcomes

  1. 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

  1. HIV-1 RNA viral load less than 50 copies/ml

    Time frame: Through week 96

    The percentage of patients with HIV-1 RNA < 50 copies/ml

  2. Immunologic response

    Time frame: Through week 96

    Cluster of differentiation 4 (CD4) cell count change from baseline

  3. HIV-1 resistance mutations

    Time frame: At baseline and at the time of virologic failure

  4. Safety and tolerability

    Time frame: Through week 96

    Incidence of adverse events and laboratory abnormalities

  5. Changes in laboratory parameters

    Time frame: Through week 96

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Collaborators

  • Abbott
  • Gilead Sciences
  • Ministry of Public Health, Democratic Republic of the Congo
  • Pierre and Marie Curie University
  • University Paris 7 - Denis Diderot
  • University of Liege

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jan 21, 2013
Registry last updated
Aug 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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