Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)
NCT ID: NCT05115838
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2024-01-04
2025-10-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Islatravir 47 mg
Participants receive an ISL 47 mg implant for approximately 52 weeks. A subset of participants will receive a second implant for 12 weeks after removal of the first implant.
Islatravir
ISL 47, 52, or 57 mg implantable rod placed subdermally on the upper arm.
Islatravir 52 mg
Participants receive an ISL 52 mg implant for approximately 52 weeks. A subset of participants will receive a second implant for 12 weeks after removal of the first implant.
Islatravir
ISL 47, 52, or 57 mg implantable rod placed subdermally on the upper arm.
Islatravir 57 mg
Participants receive an ISL 57 mg implant for approximately 52 weeks. A subset of participants will receive a second implant for 12 weeks after removal of the first implant.
Islatravir
ISL 47, 52, or 57 mg implantable rod placed subdermally on the upper arm.
Placebo
Participants receive a placebo implant for approximately 52 weeks. A subset of participants will receive a second implant for 12 weeks after removal of the first implant.
Placebo
Placebo implantable rod placed subdermally on the upper arm.
Interventions
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Islatravir
ISL 47, 52, or 57 mg implantable rod placed subdermally on the upper arm.
Placebo
Placebo implantable rod placed subdermally on the upper arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is confirmed human immunodeficiency virus (HIV)-uninfected
* Is at low risk of HIV infection
* For males, uses contraception in accordance with local regulations regarding contraception use for those participating in clinical trials
* For females, is not pregnant or breastfeeding and one of the following applies:
* Is not a participant of childbearing potential (POCBP)
* Is a POCBP and uses an acceptable contraception method or is abstinent
Exclusion Criteria
* Has a history of malignancy ≤5 years before signing informed consent
* Has a history or current evidence of any condition that might confound study results or interfere with study participation
* Has a history of keloid in upper arm or presence of tattoo, scar, or other physical finding that could interfere with implant placement (the contralateral arm may be used if the findings are limited to 1 arm)
* Is taking or is expected to take immunosuppressants during the study
18 Years
55 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-8591-043
Identifier Type: OTHER
Identifier Source: secondary_id
2021-003414-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
8591-043
Identifier Type: -
Identifier Source: org_study_id