The primary objective of this study is to evaluate the safety and tolerability of Islatravir (ISL) in trans and gender diverse (TGD) participants who are receiving gender-affirming hormone therapy (GAHT) and are at low-risk for human immunodeficiency virus 1 (HIV-1) infection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
60 mg Islatravir taken orally in tablet form once monthly for up to 24 weeks
Participants with one or more adverse events (AEs)
Number of participants with one or more AEs will be reported.
Time frame: Up to 26 weeks
Participants with an AE leading to discontinuation of study intervention
Number of participants with an AE leading to discontinuation of study intervention will be reported.
Time frame: Up to 20 weeks
Area Under the Curve (AUC) of plasma islatravir (ISL)
Area Under the Curve from time 0 to 672 hours post-dose (AUC0-672hr) of plasma islatravir (ISL) will be reported.
Time frame: Pre-dose on Day 1; any time on Weeks 1, 2 and 3; pre-dose on Weeks 4, 8, 12, 16, 20; any time on Week 24
Maximum concentration (Cmax) of plasma ISL
Maximum concentration (Cmax) of plasma ISL will be reported.
Time frame: Pre-dose on Day 1; any time on Weeks 1, 2 and 3; pre-dose on Weeks 4, 8, 12, 16, 20; any time on Week 24
Trough concentration (Ctrough) of plasma ISL
Trough concentration (Ctrough) of plasma ISL will be reported.
Time frame: Pre-dose on Day 1; any time on Weeks 1, 2 and 3; pre-dose on Weeks 4, 8, 12, 16, 20; any time on Week 24
Apparent terminal half-life (t1/2) of plasma ISL
Apparent terminal half-life (t1/2) of plasma ISL will be reported.
Time frame: Pre-dose on Day 1; any time on Weeks 1, 2 and 3; pre-dose on Weeks 4, 8, 12, 16, 20; any time on Week 24
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