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

August 22, 2013 updated by: Clumeck Nathan, Centre Hospitalier Universitaire Saint Pierre

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

425

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Katanga
      • Lubumbashi, Katanga, Congo
        • Cliniques Universitaires de Lubumbashi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Nevirapine 200 mg twice daily or 400 mg once daily per os during 96 weeks
Other Names:
  • Viramune
tenofovir 300 mg/emtricitabine 200 mg fixed-dose combination once daily, per os for 96 weeks
Other Names:
  • Truvada
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
tenofovir 300 mg/emtricitabine 200 mg fixed-dose combination once daily, per os for 96 weeks
Other Names:
  • Truvada
ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily per os during 96 weeks
Other Names:
  • Aluvia
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
Nevirapine 200 mg twice daily or 400 mg once daily per os during 96 weeks
Other Names:
  • Viramune
zidovudine 300 mg/lamivudine 150 mg twice daily fixed-dose generic combination, per os for 96 weeks
Other Names:
  • Zidolam,combivir
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
ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily per os during 96 weeks
Other Names:
  • Aluvia
zidovudine 300 mg/lamivudine 150 mg twice daily fixed-dose generic combination, per os for 96 weeks
Other Names:
  • Zidolam,combivir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At week 48 with follow-up until week 96

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through week 96
Immunologic response
Time Frame: Through week 96
Cluster of differentiation 4 (CD4) cell count change from baseline
Through week 96
HIV-1 resistance mutations
Time Frame: At baseline and at the time of virologic failure
At baseline and at the time of virologic failure
Safety and tolerability
Time Frame: Through week 96
Incidence of adverse events and laboratory abnormalities
Through week 96
Changes in laboratory parameters
Time Frame: Through week 96
Through week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

January 14, 2013

First Submitted That Met QC Criteria

January 17, 2013

First Posted (ESTIMATE)

January 21, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 22, 2013

Last Verified

August 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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