Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)
- Registration Number
- NCT05115838
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of an islatravir (ISL)-eluting implant. Participants will receive an implant placed in the upper arm for approximately 52 weeks with 8 weeks of follow-up in the Base Study. A subset of participants will also receive a second implant for an additional 12 weeks before 8 weeks of follow-up in the Substudy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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. Islatravir 57 mg Islatravir 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 47 mg Islatravir 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 52 mg Islatravir 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.
- Primary Outcome Measures
Name Time Method Percentage of participants withdrawing from study treatment due to adverse event (AE) Up to 52 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Percentage of participants with ≥1 adverse events (AEs) Up to 60 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
- Secondary Outcome Measures
Name Time Method Plasma concentration of islatravir (ISL) 12 weeks after placement of an ISL-eluting implant (ISL C12weeks) Week 12 Plasma ISL C12weeks will be determined.
Plasma concentration of islatravir (ISL) 52 weeks after placement of an ISL-eluting implant (ISL C52weeks) Week 52 Plasma ISL C52weeks will be determined.