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A Phase IV Randomized Trial to Evaluate the Virologic Response and Pharmacokinetics of Two Different Potent Regimens in HIV Infected Women Initiating Triple Antiretroviral Regimens Between 20 and 36 Weeks of Pregnancy for the Prevention of Mother-to-Child Transmission: NICHD P1081

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Trial Profile

A Phase IV Randomized Trial to Evaluate the Virologic Response and Pharmacokinetics of Two Different Potent Regimens in HIV Infected Women Initiating Triple Antiretroviral Regimens Between 20 and 36 Weeks of Pregnancy for the Prevention of Mother-to-Child Transmission: NICHD P1081

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 01 Apr 2022

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At a glance

  • Drugs Efavirenz (Primary) ; Raltegravir (Primary) ; Antiretrovirals; Lamivudine/zidovudine
  • Indications HIV-1 infections
  • Focus Adverse reactions; Therapeutic Use
  • Most Recent Events

    • 16 Feb 2022 Results (n=281) of these post hoc analyses assessing antepartum changes in wt and body mass index (BMI) between treatment arms, and examine associations between wt gain and adverse pregnancy outcomes presented at the 29th Conference on Retroviruses and Opportunistic Infections
    • 21 May 2019 Status changed from active, no longer recruiting to completed.
    • 07 Mar 2019 Results comparing the efficacy and safety of raltegravir (RAL) or efavirenz (EFV)-based antiretroviral therapy, presented at the 26th Conference on Retroviruses and Opportunistic Infections.
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