NCT02104700

Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir

Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir in Virologically-suppressed HIV-infected Rwandans (Near-Rwanda)"

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Philip Grant · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Rilpivirine/Emtricitabine/Tenofovir	Rilpivirine 25mg/Emtricitiabine 200mg/Tenofovir 300mg FDC qday

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-05-01
• Completion: 2016-07-01
• First posted: 2014-04-04
• Last updated: 2021-03-17

Locations

1 site across 1 country: Rwanda