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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
ISL 47, 52, or 57 mg implantable rod placed subdermally on the upper arm.
Placebo implantable rod placed subdermally on the upper arm.
Percentage of participants with ≥1 adverse events (AEs)
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.
Time frame: Up to 60 weeks
Percentage of participants withdrawing from study treatment due to adverse event (AE)
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.
Time frame: Up to 52 weeks
Plasma concentration of islatravir (ISL) 12 weeks after placement of an ISL-eluting implant (ISL C12weeks)
Plasma ISL C12weeks will be determined.
Time frame: Week 12
Plasma concentration of islatravir (ISL) 52 weeks after placement of an ISL-eluting implant (ISL C52weeks)
Plasma ISL C52weeks will be determined.
Time frame: Week 52
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