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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)

NCT ID: NCT05630755

Last Updated: 2025-11-18

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

514 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-17

Study Completion Date

2028-08-04

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV-1 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DOR/ISL and Placebo to BIC/FTC/TAF

Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).

Group Type EXPERIMENTAL

DOR/ISL

Intervention Type DRUG

DOR/ISL 100 mg/0.25 mg oral tablets once daily

Placebo to BIC/FTC/TAF

Intervention Type DRUG

0 mg oral tablets once daily

BIC/FTC/TAF and Placebo to DOR/ISL

Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).

Group Type ACTIVE_COMPARATOR

BIC/FTC/TAF

Intervention Type DRUG

BIC/FTC/TAF 50 mg/200 mg/25 mg oral tablets once daily

Placebo to DOR/ISL

Intervention Type DRUG

0 mg oral tablets once daily

Interventions

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DOR/ISL

DOR/ISL 100 mg/0.25 mg oral tablets once daily

Intervention Type DRUG

BIC/FTC/TAF

BIC/FTC/TAF 50 mg/200 mg/25 mg oral tablets once daily

Intervention Type DRUG

Placebo to BIC/FTC/TAF

0 mg oral tablets once daily

Intervention Type DRUG

Placebo to DOR/ISL

0 mg oral tablets once daily

Intervention Type DRUG

Other Intervention Names

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MK-8591A Doravirine/Islatravir Bictegravir/Emtricitabine/Tenofovir Alafenamide

Eligibility Criteria

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Inclusion Criteria

* Is HIV-1 positive with plasma HIV-1 RNA \<50 copies/mL
* Has been receiving BIC/FTC/TAF therapy with documented viral suppression (HIV-1 RNA \<50 copies/mL) for ≥3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen
* Female is not a participant of childbearing potential (POCBP); or if a participant of childbearing potential, not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration

Exclusion Criteria

* Has HIV-2 infection
* Has a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening
* Has active hepatitis B virus (HBV) infection
* Has chronic hepatitis C virus (HCV) infection with laboratory values consistent with cirrhosis
* Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A) inducers
* Has a documented or known virologic resistance to DOR
* Has taken long-acting HIV therapy at any time (e.g., cabotegravir, lenacapavir)
* Is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to Day 1 through the study treatment period except those currently enrolled in the comparator arm of an ongoing DOR/ISL study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Pueblo Family Physicians ( Site 1425)

Phoenix, Arizona, United States

Site Status

Pacific Oaks Medical Group ( Site 1400)

Beverly Hills, California, United States

Site Status

Ruane Clinical Research Group, Inc ( Site 1414)

Los Angeles, California, United States

Site Status

Mills Clinical Research ( Site 1433)

Los Angeles, California, United States

Site Status

Whitman-Walker Institute ( Site 1431)

Washington D.C., District of Columbia, United States

Site Status

Therafirst Medical Center ( Site 1402)

Fort Lauderdale, Florida, United States

Site Status

Midway Immunology and Research Center ( Site 1401)

Ft. Pierce, Florida, United States

Site Status

AHF The Kinder Medical Group ( Site 1426)

Miami, Florida, United States

Site Status

Orlando Immunology Center ( Site 1407)

Orlando, Florida, United States

Site Status

Triple O Research Institute, P.A ( Site 1417)

West Palm Beach, Florida, United States

Site Status

Infectious Disease Specialists of Atlanta ( Site 1403)

Decatur, Georgia, United States

Site Status

Mercer University, Department of Internal Medicine ( Site 1411)

Macon, Georgia, United States

Site Status

AccessHealth MA ( Site 1419)

Boston, Massachusetts, United States

Site Status

Be Well Medical Center ( Site 1408)

Berkley, Michigan, United States

Site Status

KC CARE Health Center-Clinical Trials ( Site 1422)

Kansas City, Missouri, United States

Site Status

Las Vegas Research Center ( Site 1436)

Las Vegas, Nevada, United States

Site Status

Regional Center for Infectious Disease Research ( Site 1435)

Greensboro, North Carolina, United States

Site Status

Central Texas Clinical Research ( Site 1413)

Austin, Texas, United States

Site Status

St Hope Foundation ( Site 1410)

Bellaire, Texas, United States

Site Status

Prism Health North Texas, Oak Cliff Health Center ( Site 1409)

Dallas, Texas, United States

Site Status

North Texas Infectious Diseases Consultants, P.A ( Site 1404)

Dallas, Texas, United States

Site Status

Texas Centers for Infectious Disease Associates ( Site 1406)

Fort Worth, Texas, United States

Site Status

The Crofoot Research Center ( Site 1424)

Houston, Texas, United States

Site Status

DCOL Center for Clinical Research ( Site 1415)

Longview, Texas, United States

Site Status

Holdsworth House Medical Practice ( Site 6200)

Darlinghurst, New South Wales, Australia

Site Status

St Vincent's Hospital-IBAC ( Site 6203)

Sydney, New South Wales, Australia

Site Status

Holdsworth House Medical Practice - Brisbane ( Site 6201)

Brisbane, Queensland, Australia

Site Status

Royal Brisbane and Women's Hospital-Infectious Diseases Research ( Site 6204)

Brisbane, Queensland, Australia

Site Status

Prahran Market Clinic ( Site 6202)

Melbourne, Victoria, Australia

Site Status

Clinica Universidad Catolica del Maule ( Site 2204)

Talca, Maule Region, Chile

Site Status

Clínica Universidad de Los Andes ( Site 2206)

Santiago, Region M. de Santiago, Chile

Site Status

Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 2200)

Santiago, Region M. de Santiago, Chile

Site Status

Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 2205)

Temuco, Región de la Araucanía, Chile

Site Status

Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 4801)

Haifa, , Israel

Site Status

Hadassah Medical Center-Infecious Disease ( Site 4802)

Jerusalem, , Israel

Site Status

Sheba Medical Center-HIV unit ( Site 4803)

Ramat Gan, , Israel

Site Status

Sourasky Medical Center ( Site 4804)

Tel Aviv, , Israel

Site Status

National Hospital Organization Nagoya Medical Center ( Site 6603)

Nagoya, Aichi-ken, Japan

Site Status

Center Hospital of the National Center for Global Health and Medicine ( Site 6601)

Shinjyuku-ku, Tokyo, Japan

Site Status

National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 66

Osaka, , Japan

Site Status

Southmead Hospital ( Site 5805)

Bristol, Bristol, City of, United Kingdom

Site Status

Queen Elizabeth Hospital Birmingham ( Site 5809)

Birmingham, England, United Kingdom

Site Status

Royal Liverpool University Hospital ( Site 5812)

Liverpool, England, United Kingdom

Site Status

Royal London Hospital ( Site 5800)

London, England, United Kingdom

Site Status

Royal Free Hospital ( Site 5801)

London, England, United Kingdom

Site Status

Guy's & St Thomas' NHS Foundation Trust ( Site 5808)

London, London, City of, United Kingdom

Site Status

The Mortimer Market Centre for Sexual Health and HIV Research ( Site 5810)

London, London, City of, United Kingdom

Site Status

University Hospital of Wales ( Site 5803)

Cardiff, Wales, United Kingdom

Site Status

Royal Berkshire Hospital ( Site 5813)

Reading, , United Kingdom

Site Status

Countries

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United States Australia Chile Israel Japan United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://msd.trialsummaries.com/Study/StudyDetails?id=26114&tenant=MT_MSD_9011

Plain Language Summary

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

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MK-8591A-052

Identifier Type: OTHER

Identifier Source: secondary_id

2022-502079-49-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

jRCT2051230003

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1283-0949

Identifier Type: REGISTRY

Identifier Source: secondary_id

8591A-052

Identifier Type: -

Identifier Source: org_study_id

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