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A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8591 Monotherapy in Anti-Retroviral Therapy (ART)-Naive, HIV-1 Infected Patients

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Trial Profile

A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8591 Monotherapy in Anti-Retroviral Therapy (ART)-Naive, HIV-1 Infected Patients

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 12 May 2022

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At a glance

  • Drugs Islatravir (Primary)
  • Indications HIV-1 infections
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Sponsors Merck Sharp & Dohme

    • Most Recent Events

    • 10 Mar 2021 Data from phase 1 (NCT02217904) and phase 2 studies (NCT04003103) were used for exposure threshold for ISL for PrEP and the corresponding oral once monthly (QM) dose for the phase 3 clinical development program, presented at the 28th Conference on Retroviruses and Opportunistic Infections.
    • 01 Mar 2018 According to a Merck & Co media release, data from this study will be present at the Conference on Retroviruses and Opportunistic Infections (CROI 2018).
    • 26 Jul 2017 Results presented at the 9th International AIDS Society Conference on HIV Science.

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