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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
425
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
Cliniques Universitaires de Lubumbashi
Lubumbashi, Katanga, Republic of the Congo
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
Time frame: At week 48 with follow-up until week 96
HIV-1 RNA viral load less than 50 copies/ml
The percentage of patients with HIV-1 RNA \< 50 copies/ml
Time frame: Through week 96
Immunologic response
Cluster of differentiation 4 (CD4) cell count change from baseline
Time frame: Through week 96
HIV-1 resistance mutations
Time frame: At baseline and at the time of virologic failure
Safety and tolerability
Incidence of adverse events and laboratory abnormalities
Time frame: Through week 96
Changes in laboratory parameters
Time frame: Through week 96
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