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Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)

NCT04223791 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 643

Last updated 2026-03-27

Study results available
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Summary

This study will evaluate the safety and efficacy of a switch to Doravirine/Islatravir (DOR/ISL) (MK-8591A) (a fixed dose combination of doravirine 100 mg and islatravir 0.75 mg) in participants living with human immunodeficiency virus-1 (HIV-1) virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to DOR/ISL (MK-8591A) will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who benefit from their assigned intervention (as determined by investigator) will be able to continue treatment through a 24-week study extension.

Conditions

  • HIV Infection

Interventions

DRUG

DOR/ISL

100 mg DOR/ 0.75 ISL FDC single tablet taken orally once daily

DRUG

BIC/FTC/TAF

50 mg BIC, 200 mg FTC, and 25 mg TAF combined in a single tablet, taken orally once daily

DRUG

Placebo to BIC/FTC/TAF

Placebo to BIC/FTC/TAF in a single tablet taken orally, once daily

DRUG

Placebo to FDC DOR/ISL

Placebo to FDC DOR/ISL in a single tablet taken orally, once daily

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-18
Primary Completion
2021-08-26
Completion
2025-02-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Finland
  • France
  • Germany
  • Italy
  • Japan
  • Puerto Rico
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04223791 on ClinicalTrials.gov