drugset / Trial / NCT03251690

Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression

NCT03251690

Completed 246 enrolled Mahidol University
RandomizedParallel-groupOpen-labelTreatment

Summary

According to the Thai National Guidelines for Treatment of HIV/AIDS 2014, the recommended first line ART regimen was 2 NRTIs backbone, TDF and FTC; plus 1 NNRTI, EFV, with RPV as an alternative one. Most of the randomized-controlled studies, including ECHO and THRIVE, showed the non-inferiority of RPV compared with EFV in naive cases. But there were not much randomized-controlled trials for changing from other NRTI to RPV in patients who currently on another ART, especially in Thailand. Moreover, the concerned adverse effects of dyslipidemia and neurological symptoms were better in RPV-based than EFV-based regimen. Finally, the cost-effectiveness and universal coverage are also the benefit of RPV over EFV in term of economics.

Timeline

Start
2016-10-27
Primary completion
2018-04-30
Completion
2018-04-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Efavirenz Other / unclassified 600 mg Oral
Subject Rilpivirine Small molecule 25 mg Oral
Comparator Tenofovir Small molecule 300 mg
Comparator emtricitabine Other / unclassified 200 mg