drugset / Trial / NCT02104700

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

NCT02104700

Phase 2/3 Completed 150 enrolled Philip Grant Gilead Sciences · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2014-04
Primary completion
2016-05
Completion
2016-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rilpivirine Small molecule 25 mg
Comparator Tenofovir Small molecule 300 mg
Comparator emtricitabine Other / unclassified 200 mg