drugset / Trial / NCT02652260
Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028)
RandomizedParallel-groupDouble-blindTreatment
Summary
This study aims to evaluate a switch from fixed dose combination (FDC) treatment with ATRIPLA\^TM for 12 weeks prior to screening to FDC treatment with Doravirine, Tenofovir, Lamivudine (MK-1439A) in virologically-suppressed, human immunodeficiency virus type 1 (HIV-1)-infected participants. The primary hypothesis is that switching from ATRIPLA\^TM to Doravirine, Tenofovir, Lamivudine results in a lower proportion of participants with at least one CNS toxicity of at least Grade 2 intensity at Week 12 than continuation of ATRIPLA\^TM treatment.
Timeline
- Start
- 2016-03-04
- Primary completion
- 2018-08-14
- Completion
- 2024-02-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doravirine | Small molecule | 100 mg | Oral |
| Subject | Efavirenz | Other / unclassified | 600 mg | Oral |
| Subject | Lamivudine | Other / unclassified | 300 mg | Oral |
| Subject | Tenofovir | Small molecule | 300 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 200 mg | Oral |