drugset / Trial / NCT02529059
SSAT058: Atripla to Eviplera Switch in Patients Without Central Nervous System Symptoms
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rilpivirine | Small molecule | 25 mg | — |
| Background | Tenofovir | Small molecule | 245 mg | — |
| Background | emtricitabine | Other / unclassified | 200 mg | — |