Nevirapine vs Ritonavir-boosted Lopinavir in ART Naive HIV-infected Adults in a Resource Limited Setting
1 other identifier
interventional
425
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 14, 2013
CompletedFirst Posted
Study publicly available on registry
January 21, 2013
CompletedAugust 26, 2013
August 1, 2013
2.8 years
January 14, 2013
August 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of therapeutic failure
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 Outcomes (5)
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
Changes in laboratory parameters
Through week 96
Study Arms (4)
nevirapine and tenofovir/emtricitabine
ACTIVE COMPARATORnevirapine 200 mg twice daily combined with tenofovir 300 mg/emtricitabine 200 mg (fixed-dose combination) once daily, per os for 96 weeks
lopinavir/r and tenofovir/emtricitabine
EXPERIMENTALritonavir-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
Nevirapine and zidovudine/lamivudine
ACTIVE COMPARATORnevirapine 200 mg/zidovudine 300 mg/lamivudine 150 mg (fixed-dose combination) twice daily, per os for 96 weeks
Lopinavir/r and zidovudine/lamivudine
EXPERIMENTALritonavir-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
Nevirapine 200 mg twice daily or 400 mg once daily per os during 96 weeks
ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily per os during 96 weeks
tenofovir 300 mg/emtricitabine 200 mg fixed-dose combination once daily, per os for 96 weeks
zidovudine 300 mg/lamivudine 150 mg twice daily fixed-dose generic combination, per os for 96 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Universitaire Saint Pierrelead
- University of Liegecollaborator
- Ministry of Public Health, Democratic Republic of the Congocollaborator
- Pierre and Marie Curie Universitycollaborator
- University Paris 7 - Denis Diderotcollaborator
- Gilead Sciencescollaborator
- Abbottcollaborator
Study Sites (1)
Cliniques Universitaires de Lubumbashi
Lubumbashi, Katanga, Republic of the Congo
Related Publications (1)
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.
PMID: 25028911DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan Clumeck, MD, PhD
Centre Hospitalier Universitaire Saint Pierre
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief infectious diseases , Professor of Medicine
Study Record Dates
First Submitted
January 14, 2013
First Posted
January 21, 2013
Study Start
December 1, 2008
Primary Completion
October 1, 2011
Study Completion
December 1, 2011
Last Updated
August 26, 2013
Record last verified: 2013-08