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A Phase II, Open Label, Single Arm Trial to Evaluate the Pharmacokinetics,Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Antiretroviral Naive HIV-1 Infected Adolescents and Children Aged ≥ 6 to <18 Years

Trial Profile

A Phase II, Open Label, Single Arm Trial to Evaluate the Pharmacokinetics,Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Antiretroviral Naive HIV-1 Infected Adolescents and Children Aged ≥ 6 to <18 Years

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 12 Sep 2023

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At a glance

  • Drugs Rilpivirine (Primary) ; Abacavir; Emtricitabine/tenofovir disoproxil fumarate; Lamivudine/abacavir; Lamivudine/tenofovir-disoproxil-fumarate; Lamivudine/zidovudine
  • Indications HIV-1 infections
  • Focus Pharmacokinetics
  • Acronyms PAINT
  • Sponsors Janssen R&D Ireland; Janssen Sciences Ireland UC
  • Most Recent Events

    • 28 Jul 2023 According to Janssen media release, the company announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of EDURANT (rilpivirine) to include the treatment of HIV-1 infection in children weighing 10 kg or more. A parallel Marketing Authorization application has also been submitted to the European Medicines Agency (EMA) in support of a type II variation and line extension for expanded pediatric use in Europe.
    • 24 Nov 2022 Status changed from active, no longer recruiting to completed.
    • 09 Jun 2022 Planned End Date changed from 1 Sep 2022 to 8 Sep 2022.
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