NCT05630755

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)

A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 514 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to evaluate the antiretroviral activity of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) at Week 48; and to evaluate the safety and tolerability of a switch to DOR/ISL compared with continued BIC/FTC/TAF, through Week 48. The primary hypotheses are that (1) DOR/ISL is non-inferior to continued BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority; and (2) DOR/ISL is superior to BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	DOR/ISL	DOR/ISL 100 mg/0.25 mg oral tablets once daily
DRUG	BIC/FTC/TAF	BIC/FTC/TAF 50 mg/200 mg/25 mg oral tablets once daily
DRUG	Placebo to BIC/FTC/TAF	0 mg oral tablets once daily
DRUG	Placebo to DOR/ISL	0 mg oral tablets once daily

Timeline

• Start date: 2023-02-17
• Primary completion: 2024-10-25
• Completion: 2028-08-04
• First posted: 2022-11-30
• Last updated: 2025-11-18
• Results posted: 2025-11-18

Locations

49 sites across 6 countries: United States, Australia, Chile, Israel, Japan, United Kingdom

Regulatory

• FDA-regulated drug study