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A Phase 1 Randomized Placebo-controlled Clinical Trial of the Safety, Pharmacokinetics and Antiviral Activity of PGT121 Monoclonal Antibody (mAb) in HIV-uninfected and HIV-infected Adults

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Trial Profile

A Phase 1 Randomized Placebo-controlled Clinical Trial of the Safety, Pharmacokinetics and Antiviral Activity of PGT121 Monoclonal Antibody (mAb) in HIV-uninfected and HIV-infected Adults

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 30 Nov 2021

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At a glance

  • Drugs PGT 121 (Primary) ; PGT 121 (Primary)
  • Indications HIV infections; HIV-1 infections
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use

    • Most Recent Events

    • 01 Oct 2021 The primary endpoints for safety, tolerability and PK were changed in protocol v.6.0, to include evaluation of both IV and SC routes, after the addition of subgroup 1D to the trial design.
    • 01 Oct 2021 Primary endpoints were changed in protocol v.8.0, to include evaluation of data from participants enrolled in the optional LTE phase that allowed additional follow-up of participants beyond day 168.
    • 01 Oct 2021 Results published in the Nature Medicine

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