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Status
Ongoing
Phase
III
Principal Investigator(s)
Sinead Delany-Moretlwe
Objective
A Phase 3 double blind safety and efficacy study of long-acting injectable Cabotegravir compared to daily oral TDF/FTC for pre-exposure prophylaxis in HIV uninfected women.
Prevention Option(s)
PrEP
Study Design
Randomized
Double-blind
Arms and Assigned Interventions
Description
Arm A – CAB LA as a single intramuscular [IM] injection at two time points four weeks apart and every eight weeks thereafter and daily oral TDF/FTC placebo plus an HIV prevention package including behavioral risk reduction and adherence counseling, provision of condoms.
Mode of Delivery
Intramuscular
Products
Cabotegravir (GSK 744)
TDF/FTC (Truvada)
ARMs
Experimental
Description
Arm B – Daily TDF/FTC and IM placebo (matching vehicle, identical volume as active injectable product in Arm A) at two time points four weeks apart and every eight weeks thereafter plus an HIV prevention package including behavioral risk reduction and adherence counseling, provision of condoms.
Mode of Delivery
Intramuscular
Products
F/TDF
ARMs
Placebo Comparator
Official Code
Trial Sponsors
NIAID, Viiv Healthcare, Gilead
October 2017
May 2022
Enrollment
3 200
18
Years
45
Years
Population
Women
Sites
Gaborone CRS
Gaborone
Botswana
Kisumu CRS
Kenya
Soweto HPTN CRS
Johannesburg, Gauteng
South Africa
Ward 21 CRS
Johannesburg
South Africa
MU-JHU Research Collaboration CRS
Kampala
Uganda
Zengeza CRS
Harare
Zimbabwe
Seke South Clinical Research Site
Harare
Zimbabwe
St Mary's CRS
Chitungwiza
Zimbabwe
UZ-Parirenyatwa
Harare
Zimbabwe
Spilhaus Clinical Research Site
Harare
Zimbabwe
Eswatini Prevention Center CRS
Mbabane
Swaziland