A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Neonates at Risk of Acquiring HIV-1 Infection

Trial Profile

A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Neonates at Risk of Acquiring HIV-1 Infection

Completed
Phase of Trial: Phase I

Latest Information Update: 29 Nov 2017

At a glance

  • Drugs Raltegravir (Primary)
  • Indications HIV-1 infections
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Most Recent Events

    • 29 Nov 2017 According to a Merck & Co. media release, status changed from recruiting to completed.
    • 29 Nov 2017 According to a Merck & Co. media release, the US FDA has approved ISENTRESS (raltegravir) for use in combination with other antiretroviral agents for the treatment of HIV-1 in neonates - newborn patients from birth to four weeks of age - weighing at least 2 kg. The approval was based on results from this trial.
    • 07 Mar 2017 Planned primary completion date changed from 1 Feb 2017 to 1 Jun 2018.
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