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A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection in women in sub-Saharan Africa. DAIDS DOCUMENT ID 12045

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Trial Profile

A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection in women in sub-Saharan Africa. DAIDS DOCUMENT ID 12045

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 09 Feb 2022

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At a glance

  • Drugs VRC 01 (Primary)
  • Indications HIV-1 infections
  • Focus Adverse reactions; Proof of concept; Therapeutic Use

Most Recent Events

  • 20 Dec 2021 Results assessing assess HIV prevention efficacy and safety of intravenous infusion of anti-gp120 broadly neutralizing antibody VRC01 published in the JAIDS
  • 18 Mar 2021 Primary endpoint (Documented HIV-1 infection by the Week 80 study visit) has not been met as per results published in the New England Journal of Medicine
  • 18 Mar 2021 Results published in the New England Journal of Medicine

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