Clinical trial NCT01772940: Nevirapine vs Ritonavir-boosted Lopinavir in ART Naive HIV-infected Adults in a Resource Limited Setting
Official title: Nevirapine vs Ritonavir-boosted Lopinavir in ART HIV-infected Adults in a Resource-limited Setting; a Randomized, Multicenter, Parallel Group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV-1 Infection
Keywords: First-line therapy
Protease inhibitor
Non-Nucleoside Reverse transcriptase Inhibitor
Resource-limited setting
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
Collaborators: name: University of Liege
name: Ministry of Public Health, Democratic Republic of the Congo
name: Pierre and Marie Curie University
name: University Paris 7 - Denis Diderot
name: Gilead Sciences
name: Abbott
First posted: 2013-01-21
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of therapeutic failure
timeFrame: At week 48 with follow-up until week 96
Secondary outcomes:
measure: HIV-1 RNA viral load less than 50 copies/ml
timeFrame: Through week 96
measure: Immunologic response
timeFrame: Through week 96
measure: HIV-1 resistance mutations
timeFrame: At baseline and at the time of virologic failure
measure: Safety and tolerability
timeFrame: Through week 96
measure: Changes in laboratory parameters
timeFrame: Through week 96
Other outcomes:
Locations:
city: Lubumbashi
country: Congo
facility: Cliniques Universitaires de Lubumbashi
state: Katanga
Study officials:
affiliation: Centre Hospitalier Universitaire Saint Pierre
name: Nathan Clumeck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.