Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents

Trial Profile

Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 31 Jul 2018

At a glance

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

    • 20 Jul 2018 Planned number of patients changed from 160 to 300.
    • 24 May 2018 Planned primary completion date changed from 1 May 2018 to 30 Jun 2020.
    • 10 Jun 2017 Biomarkers information updated
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