drugset / Trial / NCT03405194
Same-Day Treatment With Genvoya vs. EFV/TDF/3TC
Withdrawn
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Analysis Group, Inc. · collabBrigham and Women's Hospital · collabGilead Sciences · collabWeill Medical College of Cornell University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Randomized, open-label study comparing Elvitegravir-Cobicistat-Tenofovir Alafenamide-Emtricitabine (Genvoya) vs. Efavirenz-Tenofovir Disoproxil Fumarate-Lamivudine (EFV-TDF-3TC) in patients starting ART on the day of HIV diagnosis.
Timeline
- Start
- 2018-05-01
- Primary completion
- 2020-05-01
- Completion
- 2020-07-01
Outcome
Outcome not reported
Stopped (Enrollment): “Haiti gained access to dolutegravir as first-line ART, so we cancelled the study before any patient was enrolled (we didn't want SOC group to receive EFV)”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cobicistat | Small molecule | 150 mg | Oral |
| Comparator | Efavirenz | Other / unclassified | 600 mg | Oral |
| Subject | FTC | Unknown | 200 mg | — |
| Comparator | Lamivudine | Other / unclassified | 300 mg | — |
| Subject | TAF | Unknown | 10 mg | Oral |
| Comparator | TDF | Unknown | 300 mg | Oral |
| Subject | elvitegravir | Small molecule | 150 mg | Oral |