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Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of the IMPAACT 1077 PROMISE Protocol (Promoting Maternal and Infant Survival Everywhere)

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Trial Profile

Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of the IMPAACT 1077 PROMISE Protocol (Promoting Maternal and Infant Survival Everywhere)

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 22 May 2023

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At a glance

  • Drugs Tenofovir disoproxil fumarate (Primary)
  • Indications HIV infections
  • Focus Pharmacodynamics; Pharmacokinetics
  • Acronyms PROMISE

    • Most Recent Events

    • 15 May 2023 Results from P1084s substudy (n=400 ) assessing Bone and renal health in infants with or without breastmilk exposure to tenofovir-based maternal antiretroviral treatment , published in the JAIDS
    • 16 Feb 2022 Results assessing outcomes in a subset of mother-infant (MI) pairs randomized to either maternal TDF-based ART [TDF/ FTC+LPV/r] (mART) or infant nevirapine prophylaxis [no maternal ART] (iNVP) during breastfeeding as part of the IMPAACT PROMISE study, presented at the 29th Conference on Retroviruses and Opportunistic Infections.
    • 10 Mar 2021 Results estimating the association between hair TFV levels and viremia using subset of women randomized in this trial presented at the 28th Conference on Retroviruses and Opportunistic Infections
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