The purpose of this study is to quantify the magnitude and extent of infant exposure to daily emtricitabine (FTC) /tenofovir disoproxil fumarate (TDF) via maternal breastmilk when taken pre-exposure prophylaxis (PrEP) by lactating HIV-uninfected women. The primary outcome is the steady state concentrations of emtricitabine and tenofovir in the infant plasma.
Age range
18 Years
Sex
FEMALE
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Steady state plasma concentrations of emtricitabine and tenofovir in the infants of breastfeeding women using PrEP: Quantity of PrEP medications in the infant plasma.
Timeframe: Time averaged: 10 days
Steady state plasma concentrations of emtricitabine and tenofovir in the infants of breastfeeding women using PrEP: Detectable and quantifiable concentrations of PrEP medications in the infant plasma.
Timeframe: Time averaged: 10 days
Steady state concentrations of emtricitabine and tenofovir in plasma of HIV-uninfected women using PrEP.
Timeframe: Time averaged: 10 days
Steady state concentrations of emtricitabine and tenofovir in breastmilk of HIV-uninfected women using PrEP.
Timeframe: Time averaged: 10 days
Infant plasma-to-maternal breast milk emtricitabine and tenofovir concentration ratios.
Timeframe: Time averaged: 10 days
Infant daily dose of tenofovir and emtricitabine received from breastmilk
Timeframe: Time averaged: 10 days
Infant dose fraction for tenofovir and emtricitabine.
Timeframe: Time averaged: 10 days
Maternal breastmilk emtricitabine and tenofovir to plasma concentration ratios.
Timeframe: Time averaged: 10 days
Serious adverse events in infants of breastfeeding HIV-uninfected women using PrEP.
Timeframe: Time averaged: 10 days
Serious adverse events in breastfeeding HIV-uninfected women using PrEP.
Timeframe: Time averaged: 10 days