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: 14 Nov 2017

At a glance

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

    • 10 Jun 2017 Biomarkers information updated
    • 16 Feb 2017 Results (n=10) presented at the 24th Conference on Retroviruses and Opportunistic Infections.
    • 16 Dec 2016 According to a ViiV Healthcare media release, based on 24 week data from this study, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the Type II variation and extension applications to reduce the weight and age limit for the treatment of HIV in children and adolescents with Tivicay (dolutegravir) from at least 40kg to at least 15kg.
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