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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: 26 Apr 2024

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At a glance

  • Drugs Tenofovir disoproxil fumarate (Primary)
  • Indications HIV infections
  • Focus Pharmacodynamics; Pharmacokinetics
  • Acronyms IMPAACT PROMISE 1077BF; PROMISE

    • Most Recent Events

    • 06 Mar 2024 Results of nested case-control postpartum substudy (n=93) assessing the association of vertical HIV-1 transmission with HIV VL in plasma and BM, and with tenofovir (TFV) drug levels concentrations, presented at the 31st Conference on Retroviruses and Opportunistic Infections 2024.
    • 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.

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