Trial reportAIDS (London, England)2026
Islatravir distribution in plasma, peripheral blood mononuclear cells, and mucosal tissues after monthly oral dosing.
Trial report in AIDS (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04003103 (A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral MK-8591 Once-Monthly in Participants at Low- Risk for HIV-1 Infection), which is not on this map. Not yet cited in PubMed.
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A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral MK-8591 Once-Monthly in Participants at Low- Risk for HIV-1 Infection
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20 authors.
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Abstract
objectiveIslatravir is a nucleoside reverse transcriptase translocation inhibitor (NRTTI) under development for HIV-1 treatment. We aimed to evaluate the pharmacokinetics (PK) of islatravir and its active form, islatravir-triphosphate, in blood and mucosal tissues.
designThis was an exploratory substudy of a randomized, double-blind, placebo-controlled, multicenter, Phase 2a study of once-monthly islatravir in adults at low likelihood of HIV-1 exposure (NCT04003103).
methodsParticipants were randomly assigned 2 : 2 : 1 to receive 6 once-monthly oral doses of islatravir 60 mg, islatravir 120 mg, or placebo. Plasma, peripheral blood mononuclear cell (PBMC), and cervical, vaginal, and rectal tissue samples were collected at Weeks 1, 4, 24, and 32. Samples were assayed by liquid chromatography with tandem mass spectrometry. Intercompartmental ratios and regression analyses were assessed.
resultsThe analyses included 44 participants who received islatravir 60 mg or 120 mg (73% assigned female at birth; median age 30 years). Following 6 once-monthly doses, islatravir-triphosphate trough concentrations were comparable across homogenized mucosal tissue samples and isolated rectal cells. Median venous whole blood islatravir (total of islatravir and key anabolites) to mucosal tissue islatravir-triphosphate concentration ratios ranged from 0.565 to 1.490 four weeks after the sixth islatravir dose. Adjusted R2 coefficients between islatravir concentrations in venous whole blood and islatravir-triphosphate concentrations in rectal, cervical, and vaginal tissues across sampling times were 0.67, 0.76, and 0.75, respectively.
conclusionsThe favorable tissue distribution of islatravir and islatravir-triphosphate following oral administration supports the evaluation of NRTTIs for HIV-1 preexposure prophylaxis.
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