The most frequently reported adverse events were mild-to-moderate implant-site reactions (induration, hematoma, pain). Based on preclinical data, two doses were assessed: 54 mg ( n = 8, two placebo) and 62 mg ( n = 8, two placebo). Secondary end points included additional pharmacokinetic parameters for islatravir triphosphate in PBMCs and the plasma pharmacokinetic profile of islatravir. The co-primary end points were safety and tolerability of the islatravir implant and pharmacokinetics, including concentration at day 85, of islatravir triphosphate in peripheral blood mononuclear cells (PBMCs). Participants received islatravir or placebo subdermal implants for 12 weeks and were monitored throughout this period and after implant removal. We conducted a randomized, double-blind, placebo-controlled, phase 1 trial in adults without HIV-1 infection. Islatravir (MK-8591) is a highly potent type 1 human immunodeficiency virus (HIV-1) nucleoside reverse transcriptase translocation inhibitor with a long intracellular half-life that is in development for the prevention and treatment of HIV-1.
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