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Open-Label, Dose-Escalating, Phase I Study to Determine Safety and Pharmacokinetic Parameters of Subcutaneous (SC) VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants

Trial Profile

Open-Label, Dose-Escalating, Phase I Study to Determine Safety and Pharmacokinetic Parameters of Subcutaneous (SC) VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 31 Oct 2023

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At a glance

  • Drugs TMB-380 (Primary) ; VRC 01 (Primary) ; VRC 01LS (Primary)
  • Indications HIV-1 infections
  • Focus Adverse reactions; Pharmacokinetics

Most Recent Events

  • 12 Sep 2023 Results developing a population pharmacokinetic (popPK) model from infants from this study for adults from another study, to understand factors affecting VRC07-523LSdisposition and predict infants exposures associated with potential use during breastfeeding, presented at the 2023 American College of Clinical Pharmacology Annual Meeting
  • 16 Feb 2022 Results presented at the 29th Conference on Retroviruses and Opportunistic Infections
  • 12 Jan 2022 Status changed from active, no longer recruiting to completed.

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