A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for HIV-1 Infection
Overview
- Phase
- Phase 2
- Intervention
- Islatravir
- Conditions
- Human Immunodeficiency Virus
- Sponsor
- Merck Sharp & Dohme LLC
- Primary Endpoint
- Percentage of participants withdrawing from study treatment due to adverse event (AE)
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Arms & Interventions
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.
Intervention: Islatravir
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.
Intervention: Islatravir
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.
Intervention: Islatravir
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of participants withdrawing from study treatment due to adverse event (AE)
Time Frame: 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)
Time Frame: 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 Outcomes
- Plasma concentration of islatravir (ISL) 12 weeks after placement of an ISL-eluting implant (ISL C12weeks)(Week 12)
- Plasma concentration of islatravir (ISL) 52 weeks after placement of an ISL-eluting implant (ISL C52weeks)(Week 52)