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P1084s / Maternal Infant TDF Toxicity Safety
Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of PROMISE Protocol: Promoting Maternal and Infant Survival Everywhere
Study Status
Closed to Follow Up
DAIDS Number
10790
IND Number
107,547
Clinical Trials Link
Primary Protocol Team Members
Summary
P1084s is a nested, comparative substudy of HIV-1-infected women and their infants randomized in PROMISE to receive a maternal tenofovir-containing regimen or no maternal tenofovir-containing regimen during pregnancy or breastfeeding for prevention of mother-to-child transmission. This substudy is designed to examine bone, renal and growth outcomes of tenofovir exposure during pregnancy or during breastfeeding in 1077BF and 1077FF.
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