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Raltegravir Pharmacokinetics and Safety in Neonates

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Trial Profile

Raltegravir Pharmacokinetics and Safety in Neonates

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Raltegravir (Primary)
  • Indications HIV-1 infections
  • Focus Adverse reactions; Pharmacokinetics
  • Acronyms IMPAACT-P1097

    • Most Recent Events

    • 02 Feb 2021 Data from 3 studies (TEmAA, IMPAACT P1026 & IMPAACT P1097) were used pharmacokinetic modeling framework to predict neonatal pharmacokinetics of transplacentally acquired emtricitabine, dolutegravir, and raltegravir, published in the Clinical Pharmacokinetics.
    • 09 Sep 2020 Results assessing safety and pharmacokinetics (raltegravir clearance) in low birth weight neonates born to pregnant women living with HIV and received raltegravir during pregnancy published in the JAIDS
    • 23 Jul 2018 Status changed from active, no longer recruiting to completed.

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