Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)
Summary
This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL \[also known as MK-8591A\]) in treatment-naïve participants living with human immunodeficiency virus type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity, safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that DOR/ISL is noninferior or superior to BIC/FTC/TAF treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.
Timeline
- Start
- 2020-02-28
- Primary completion
- 2022-11-17
- Completion
- 2025-01-29
Outcome
Met primary endpoint
registry analysis (non-inferiority test); Group 1: DOR/ISL vs Group 2: BIC/FTC/TAF; Treatment Difference 0.46 (95% CI -4.73 to 5.60) NCT04233879 ↗
paper Doravirine/islatravir was noninferior to bictegravir/emtricitabine/tenofovir alafenamide: PMID 40079835 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | BIC/FTC/TAF | Unknown | 25 mg | Oral |
| Comparator | BIC/FTC/TAF | Unknown | 50 mg | Oral |
| Comparator | BIC/FTC/TAF | Unknown | 200 mg | Oral |
| Subject | DOR/ISL | Unknown | 0.75 mg | Oral |
| Subject | DOR/ISL | Unknown | 100 mg | Oral |