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

This study has been completed.
Sponsor:
Collaborators:
University Hospital of Liege
Ministry of Public Health, Democratic Republic of the Congo
Pierre and Marie Curie University
University Paris 7 - Denis Diderot
Gilead Sciences
Abbott
Information provided by (Responsible Party):
Clumeck Nathan, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier:
NCT01772940
First received: January 14, 2013
Last updated: August 22, 2013
Last verified: August 2013

January 14, 2013
August 22, 2013
December 2008
October 2011   (final data collection date for primary outcome measure)
Incidence of therapeutic failure [ Time Frame: At week 48 with follow-up until week 96 ] [ Designated as safety issue: Yes ]

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
incidence of therapeutical failure [ Time Frame: At week 96 ] [ Designated as safety issue: Yes ]

The primary end point is the proportion of patients with therapeutical 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
Complete list of historical versions of study NCT01772940 on ClinicalTrials.gov Archive Site
  • HIV-1 RNA viral load less than 50 copies/ml [ Time Frame: Through week 96 ] [ Designated as safety issue: No ]
    The percentage of patients with HIV-1 RNA < 50 copies/ml
  • Immunologic response [ Time Frame: Through week 96 ] [ Designated as safety issue: No ]
    Cluster of differentiation 4 (CD4) cell count change from baseline
  • HIV-1 resistance mutations [ Time Frame: At baseline and at the time of virologic failure ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Through week 96 ] [ Designated as safety issue: Yes ]
    Incidence of adverse events and laboratory abnormalities
  • Changes in laboratory parameters [ Time Frame: Through week 96 ] [ Designated as safety issue: No ]
HIV-1 RNA viral load less than 50 copies/ml [ Time Frame: at week 96 ] [ Designated as safety issue: No ]
The percentage of patients with HIV-1 RNA < 50 copies/ml
Not Provided
immunological response [ Time Frame: At week 96 ] [ Designated as safety issue: No ]
Cluster of differentiation 4 (CD4) cell count change from baseline
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1 Infection
  • Drug: nevirapine
    Nevirapine 200 mg twice daily or 400 mg once daily per os during 96 weeks
    Other Name: 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 Name: Aluvia
  • Drug: Tenofovir/emtricitabine
    tenofovir 300 mg/emtricitabine 200 mg fixed-dose combination once daily, per os for 96 weeks
    Other Name: Truvada
  • Drug: Zidovudine/lamivudine
    zidovudine 300 mg/lamivudine 150 mg twice daily fixed-dose generic combination, per os for 96 weeks
    Other Name: Zidolam,combivir
  • Active Comparator: nevirapine and tenofovir/emtricitabine
    nevirapine 200 mg twice daily combined with tenofovir 300 mg/emtricitabine 200 mg (fixed-dose combination) once daily, per os for 96 weeks
    Interventions:
    • Drug: nevirapine
    • Drug: Tenofovir/emtricitabine
  • Experimental: lopinavir/r and tenofovir/emtricitabine
    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
    Interventions:
    • Drug: ritonavir-boosted Lopinavir
    • Drug: Tenofovir/emtricitabine
  • Active Comparator: Nevirapine and zidovudine/lamivudine
    nevirapine 200 mg/zidovudine 300 mg/lamivudine 150 mg (fixed-dose combination) twice daily, per os for 96 weeks
    Interventions:
    • Drug: nevirapine
    • Drug: Zidovudine/lamivudine
  • Experimental: Lopinavir/r and zidovudine/lamivudine
    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
    Interventions:
    • Drug: ritonavir-boosted Lopinavir
    • Drug: Zidovudine/lamivudine
Clumeck N, Mwamba C, Kabeya K, Matanda S, Vaira D, Necsoi C, Kadiebwe D, Delforge M, Kasamba E, Milolo C, Ilunga J, Kapend L. First-line antiretroviral therapy with nevirapine versus lopinavir-ritonavir based regimens in a resource-limited setting. AIDS. 2014 May 15;28(8):1143-53. doi: 10.1097/QAD.0000000000000214.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
425
December 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Congo
 
NCT01772940
Lubumbashi trial
Yes
Clumeck Nathan, Centre Hospitalier Universitaire Saint Pierre
Centre Hospitalier Universitaire Saint Pierre
  • University Hospital of Liege
  • Ministry of Public Health, Democratic Republic of the Congo
  • Pierre and Marie Curie University
  • University Paris 7 - Denis Diderot
  • Gilead Sciences
  • Abbott
Principal Investigator: Nathan Clumeck, MD, PhD Centre Hospitalier Universitaire Saint Pierre
Centre Hospitalier Universitaire Saint Pierre
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP