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Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)

NCT ID: NCT04644029

Last Updated: 2026-02-04

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

730 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-24

Study Completion Date

2024-06-11

Brief Summary

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This study will evaluate whether oral islatravir (ISL) is effective in preventing Human Immunodeficiency Virus Type 1 (HIV-1) infection in women at high-risk for HIV-1 infection. The study will compare oral ISL taken once a month with standard-of-care medication for prevention of HIV-1 infection, emtricitabine/tenofovir disoproxil (FTC/TDF), taken once per day. The primary hypothesis is that oral ISL is more effective than FTC/TDF at reducing the incidence rate per year of confirmed HIV-1 infections.

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Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)

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Detailed Description

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Based on laboratory findings of decreased lymphocyte and CD4+ T-cell counts across the islatravir program, dosing of blinded study intervention was halted on 13-Dec-2021 and screening and randomization of new participants was ended. Blinded assessments conducted prior to this date are designated as Study Part 1. During Study Part 2, participants from Part 1 have the option to receive daily open-label FTC/TDF while continuing in the study for safety monitoring. Study Part 3 was added to unblind each participant's Part 1 study intervention assignment, continue participants on FTC/TDF, and monitor safety.

Conditions

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HIV-I Human Immunodeficiency Virus Type 1 Prophylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
In Study Part 1, a double-blinding technique with in-house blinding will be used. ISL and FTC/TDF will be packaged identically relative to their matching placebos so that blind is maintained. The participant, the investigator, and Sponsor personnel or delegate(s) who are involved in the study intervention administration or clinical evaluation of the participants are unaware of the intervention assignments.

In Study Part 2, sponsor personnel not directly involved with blinded safety monitoring will be unblinded to participants' randomized study intervention in Part 1.

In Study Part 3, participants, investigators, and all Sponsor personnel will be unblinded to the participants' original randomized study intervention group.

Study Groups

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ISL QM

ISL (islatravir) once monthly AND placebo to FTC/TDF (emtricitabine/tenofovir disoproxil) once daily. Following study-wide cessation of ISL administration, participants had the option to receive open-label FTC/TDF administered once daily.

Group Type EXPERIMENTAL

Islatravir

Intervention Type DRUG

Oral 60 mg tablet administered once monthly during Part 1.

Placebo to FTC/TDF

Intervention Type DRUG

0 mg tablet administered once daily during Part 1.

FTC/TDF QD

FTC/TDF (TRUVADA™ or generic product emtricitabine/tenofovir disoproxil) administered once daily. Placebo to ISL (islatravir) administered once monthly. Following study-wide cessation of ISL administration, participants had the option to continue on open-label FTC/TDF. Placebo was no longer administered once open label treatment began.

Group Type ACTIVE_COMPARATOR

FTC/TDF

Intervention Type DRUG

Each tablet contains 200 mg emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg tenofovir disoproxil fumarate or 201.22 mg tenofovir disproxil phosphate), administered orally once daily in Parts 1, 2, and 3.

Placebo to ISL

Intervention Type DRUG

0 mg tablet administered orally once monthly in Part 1.

Interventions

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Islatravir

Oral 60 mg tablet administered once monthly during Part 1.

Intervention Type DRUG

Placebo to FTC/TDF

0 mg tablet administered once daily during Part 1.

Intervention Type DRUG

FTC/TDF

Each tablet contains 200 mg emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg tenofovir disoproxil fumarate or 201.22 mg tenofovir disproxil phosphate), administered orally once daily in Parts 1, 2, and 3.

Intervention Type DRUG

Placebo to ISL

0 mg tablet administered orally once monthly in Part 1.

Intervention Type DRUG

Other Intervention Names

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MK-8591 TRUVADA™ Emtricitabine/Tenofovir disoproxil Emtricitabine/Tenofovir disoproxil fumarate

Eligibility Criteria

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Inclusion Criteria

* Confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results before randomization.
* Sexually active (vaginal and/or anal sex) with a male sexual partner in the 30 days prior to screening.
* High risk for HIV-1 infection.
* Not pregnant or breastfeeding, and one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or is a WOCBP and is using an acceptable contraceptive method during the intervention period and for at least 42 days after the last dose.
* A WOCBP must have a negative pregnancy test within 24 hours prior to the first dose of study intervention.

Exclusion Criteria

* Hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator.
* Findings of chronic hepatitis B virus (HBV) infection or past HBV.
* Current or chronic history of liver disease.
* History of malignancy within 5 years of screening except for adequately-treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
* Past or current use of cabotegravir, lenacapavir, or any other long-acting HIV prevention product.
* Currently participating in or has participated in an interventional clinical study with an investigational compound or device, within 30 days prior to Day 1.
* Expecting to conceive or donate eggs at any time during the study.
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

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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University of Alabama at Birmingham-UAB Sexual Health Research Clinic (SHRC) ( Site 0064)

Birmingham, Alabama, United States

Site Status

MedStar Health Research Institute (MedStar Physician Based R-MedStar Washington Hospital Center ( Si

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

Site Status

University of Miami Miller School of Medicine-Infectious Disease ( Site 0076)

Miami, Florida, United States

Site Status

Orlando Immunology Center ( Site 0068)

Orlando, Florida, United States

Site Status

Ponce De Leon Center Grady Health ( Site 0066)

Atlanta, Georgia, United States

Site Status

The University of Mississippi Medical Center ( Site 0065)

Jackson, Mississippi, United States

Site Status

KC CARE Health Center-Clinical Trials ( Site 0059)

Kansas City, Missouri, United States

Site Status

Rutgers New Jersey Medical School-Clinical Research Center ( Site 0071)

Newark, New Jersey, United States

Site Status

Bronx Prevention Center ICAP ( Site 0062)

The Bronx, New York, United States

Site Status

The University of North Carolina at Chapel Hill-Medicine ( Site 0056)

Chapel Hill, North Carolina, United States

Site Status

Prisma Health Richland Hospital-Clinical Research Unit ( Site 0069)

Columbia, South Carolina, United States

Site Status

Prism Health North Texas, Oak Cliff Health Center ( Site 0070)

Dallas, Texas, United States

Site Status

West Virginia University-Department of Medicine ( Site 0061)

Morgantown, West Virginia, United States

Site Status

Perinatal HIV Research Unit (PHRU)-HIV Prevention CRS ( Site 0023)

Johannesburg, Gauteng, South Africa

Site Status

Wits Reproductive Health and HIV Institute (WRHI)-Wits RHI Ward 21 Clinical Research site ( Site 002

Johannesburg, Gauteng, South Africa

Site Status

Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0020)

Johannesburg, Gauteng, South Africa

Site Status

Setshaba Research Centre ( Site 0016)

Pretoria, Gauteng, South Africa

Site Status

SA Medical Research Council - Chatsworth Clinical Research Site ( Site 0030)

Chatsworth, KwaZulu-Natal, South Africa

Site Status

Maternal Adolescent and Child Health Research (MatCH) ( Site 0025)

Durban, KwaZulu-Natal, South Africa

Site Status

Qhakaza Mbokodo Research Clinic ( Site 0017)

Ladysmith, KwaZulu-Natal, South Africa

Site Status

Madibeng Centre for Research ( Site 0019)

Brits, North West, South Africa

Site Status

Aurum Institute Klerksdorp CRS ( Site 0029)

Klerksdorp, North West, South Africa

Site Status

Aurum Institute - Rustenburg ( Site 0022)

Rustenburg, North West, South Africa

Site Status

MU-JHU Care Limited-Clinic ( Site 0041)

Kampala, , Uganda

Site Status

Countries

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United States South Africa Uganda

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

https://www.trialsummaries.com/Study/StudyDetails?id=26659&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

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MK-8591-022

Identifier Type: OTHER

Identifier Source: secondary_id

2021-001289-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

8591-022

Identifier Type: -

Identifier Source: org_study_id

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