HPTN 084

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

NCT03164564

Trial Sponsors

NIAID, Viiv Healthcare, Gilead

October 2017

May 2022

Enrollment

3 200

Years

Population

Women

Sites

Gaborone CRS

Gaborone

Botswana

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