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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
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