Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)
Human Immunodeficiency Virus, HIV
About this trial
This is an interventional prevention trial for Human Immunodeficiency Virus
Eligibility Criteria
Inclusion Criteria:
- Is in good health
- 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 an active diagnosis of hepatitis (B or C) due to any cause
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Islatravir 47 mg
Islatravir 52 mg
Islatravir 57 mg
Placebo
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.
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.
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.
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.