2,059
Participants
Start Date
October 31, 2011
Primary Completion Date
August 31, 2014
Study Completion Date
August 31, 2014
Tenofovir gel
Tenofovir gel is a clear, transparent, viscous gel at concentrations of 1% formulated in purified water with edentate disodium, citric acid, glycerin, methylparaben, propylparaben, HEC, and pH adjusted to 4-5. Tenofovir gel will be supplies in a 4 ml single use applicator containing approximately 4 grams of gel, equivalent to approximately 40mg of tenofovir.
Universal placebo gel
The placebo gel is an inert gel containing HEC as the gelling agent, purified water, sodium chloride, sorbic acid and sodium hydroxide. Each applicator contains approximately 4ml of placebo gel
MatCH Edendale Research Center, Pietermaritzburg
Qhakaza Mbokodo Research Clinic, Ladysmith
Desmond Tutu HIV Centre / University of Cape Town, Cape Town
Perinatal HIV Research Unit / University of the Witwatersrand, Diepkloof
Wits Reproductive Health and HIV Institute / University of the Witwatersrand, Hillbrow
Medunsa Clinical Research Unit / Ga-Ra, Pretoria
The Aurum Institute (Rustenburg), Rustenburg
Setshaba Research Centre, Soshanguve
The Aurum Institute, Tembisa Hospital, Tembisa
Follow-on African Consortium for Tenofovir Studies (FACTS)
UNKNOWN
United States Agency for International Development (USAID)
FED
CONRAD
OTHER