HPTN 084
Status:Stopped Early
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. Last updated Dec 23, 2021
Prevention Option(s):PrEP
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionArm 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 DeliveryIntramuscular
ARMsExperimental
DescriptionArm 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 DeliveryIntramuscular
ARMsPlacebo Comparator
Official Code:
NCT03164564
Trial Sponsors:
Gilead, NIAID (DAIDS-ES: 38070), ViiV Healthcare
Start Date
End Date
October 23, 2017
May 12, 2022
Enrollment:3,200
Age range:
18 Years ↔
45 Years
Population:Cisgender Women