The study will be an open-label, pilot study in virologically suppressed patients comparing the efficacy, safety and tolerability of two Antiretroviral regimen strategies: Arm A: "Immediate switch" Rilpivirine/Emtricitabine/Tenofovir (single tablet formulation (STF))at randomization Arm B: "Delayed switch" Continue Nevirapine/Lamivudine/other Nucleoside reverse transcriptase inhibitor (NRTI)through 24 weeks then switch to STF of Rilpivirine/emtrictabine/tenofovir and followed through 48 weeks.
The current study is designed to be the first study to compare a continued nevirapine-based regimen to a switch to the FDC of rilpivirine/emtricitabine/tenofovir. Rwanda is a model country for implementation of newer approaches to more innovative ART strategies with an excellent National HIV Treatment program in place but has limited experience with clinical trials and as with most African countries has no clinical experience with Rilpivirine in treating HIV infected adults. Done in collaboration with Rwanda Biomedical center.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Rilpivirine 25mg/Emtricitiabine 200mg/Tenofovir 300mg FDC qday
Rwanda Military Hospital
Kinombe, Rwanda
Explore Efficacy
To compare proportion of subjects successfully maintaining a plasma viral load \<200 copies /mL at week 24 in subjects randomized to rilpivirine/emtricitabine/tenofovir vs. in those randomized to initially continue nevirapine-based ART in this pilot study.
Time frame: 24 weeks
HIV RNA levels
To compare between arms the probability of having an HIV RNA level \<50 and \<400 copies/mL at 24 weeks
Time frame: 24 weeks
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