drugset / Trial / NCT02529059

SSAT058: Atripla to Eviplera Switch in Patients Without Central Nervous System Symptoms

NCT02529059

Phase 4 Completed 40 enrolled St Stephens Aids Trust Gilead Sciences · collab
NaSingle-groupOpen-labelTreatment

Summary

This study aims to investigate whether substitution of Efavirenz (EFV) as the Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) fixed-dose combination (FDC) Atripla, with Rilpivirine as the tenofovir/emtricitabine/rilpivirine (TDF/FTC/RPV) fixed-dose combination (FDC) Eviplera, leads to resolution of covert Central Nervous System (CNS) toxicity associated with EFV, continued virological suppression and immunological reconstitution and whether this is associated with an improvement in quality of life, sleep, anxiety/depression and neurocognitive function; the impact of switch on adherence will also be investigated.

Timeline

Start
2015-11
Primary completion
2017-05
Completion
2017-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Rilpivirine Small molecule 25 mg
Background Tenofovir Small molecule 245 mg
Background emtricitabine Other / unclassified 200 mg