A Phase I/II, Open-Label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Etravirine (ETR) in Antiretroviral (ARV) Treatment-Experienced HIV-1 Infected Infants and Children, Aged ≥ 2 Months to < 6 Years

Trial Profile

A Phase I/II, Open-Label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Etravirine (ETR) in Antiretroviral (ARV) Treatment-Experienced HIV-1 Infected Infants and Children, Aged ≥ 2 Months to < 6 Years

Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 10 Aug 2018

At a glance

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

    • 24 May 2018 Planned End Date changed from 31 Jul 2023 to 31 Oct 2021.
    • 24 May 2018 Planned primary completion date changed from 30 Jun 2018 to 30 Jul 2018.
    • 07 Mar 2018 Results (n=21; Cohort 1 and 2) assessing Etravirine pharmacokinetics in children ages 1 to less than 6 years, presented at the 25th Conference on Retroviruses and Opportunistic Infections.
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