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