Email Updates

Search form

You are here

HPTN 084

Status
Planned
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
Trial Sponsors
NIAID, Viiv Healthcare, Gilead
October 2017
May 2022
Enrollment
3 200
18
Years
45
Years
Population
Women
Sites

Site(s) - Botswana

Botswana

Site(s) - Kenya

Kenya

Site(s) - Malawi

Malawi

Site(s) - South Africa

South Africa

Site(s) - Swaziland

Swaziland

Site(s) - Uganda

Uganda

Site(s) - Zimbabwe

Zimbabwe