NCT03327155: PrEPIT-WA

Western Australian Pre-exposure Prophylaxis for HIV Implementation Trial

Completed Phase 3 Last updated 4 September 2020

What this trial tests

Phase 3 trial testing Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) in HIV Prevention in 900 participants. Completed in 20 July 2020.

Timeline

16 November 2017

Primary endpoint
30 April 2019

20 July 2020

Quick facts

Lead sponsor	Kirby Institute
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	900
Start date	16 November 2017
Primary completion	30 April 2019
Estimated completion	20 July 2020
Sites	4 locations across Australia

Drugs / interventions tested

• Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) — full drug profile →

Conditions studied

• HIV Prevention — all drugs for HIV Prevention →

Sponsor

Kirby Institute

Who can join

18 and older, any sex, with HIV Prevention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Despite all prevention efforts, many people in Australia continue to be infected with HIV. The Seventh National HIV Strategy 2014-2017 in Australia aims to work towards the elimination of HIV transmission by the year 2020. This project will evaluate a new additional way to lower people's chances of getting HIV. It will provide pre-exposure prophylaxis (PrEP) to people who are at high risk for HIV and evaluate what impact this new prevention approach will have on HIV in WA at the community level.

The drug used in PREPIT-WA is called generic TDF/FTC (made by Mylan Laboratories Ltd.). The generic TDF/FTC is a single tablet made up of two HIV medications: tenofovir disoproxil fumarate and emtricitabine (a combination known as TDF/FTC). TDF and FTC have been widely used for many years to treat HIV. When used with other medicines in people who already have HIV, TDF/FTC reduces the amount of HIV virus in the blood. TDF/FTC does not cure HIV or AIDS, and it is not an HIV vaccine.

As a treatment for people who already have HIV, TDF/FTC is approved for use in most of the world, including Australia. As a medicine for PrEP, to lower chances of HIV in those who are not infected, TDF/FTC has been approved in the US, and Truvada® (which contains TDF/FTC made by Gilead Sciences Inc.) was approved for PrEP in Australia in May 2016. At the start of the project, the generic TDF/FTC is not approved in Australia for the use as PrEP but it may become registered for use and more freely available in Australia in the future.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.