PrEP in Breastfeeding Study

Phase 2/3 Completed 50 enrolled University of Washington Bill and Melinda Gates Foundation · collab

NaSingle-groupOpen-labelPrevention

Summary

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.

Timeline

Start: 2015-01
Primary completion: 2015-05
Completion: 2015-12

Publications

Mugwanya KK, Hendrix CW, Mugo NR, Marzinke M, Katabira ET, Ngure K, Semiyaga NB, John-Stewart G, Muwonge TR, Muthuri G, Stergachis A, Celum CL, Baeten JM. Pre-exposure Prophylaxis Use by Breastfeeding HIV-Uninfected Women: A Prospective Short-Term Study of Antiretroviral Excretion in Breast Milk and Infant Absorption. PLoS Med. 2016 Sep 27;13(9):e1002132. doi: 10.1371/journal.pmed.1002132. eCollection 2016 Sep.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenofovir disoproxil fumarate	Small molecule	300 mg	Oral
Subject	emtricitabine	Other / unclassified	200 mg	Oral

Indications

No indication recorded.