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Western Australian Pre-exposure Prophylaxis for HIV Implementation Trial

NCT03327155 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2020-09-04

No results posted yet for this study

Summary

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.

Conditions

  • HIV Prevention

Interventions

DRUG

Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC)

One tablet, containing 300mg of TDF and 200mg of FTC once daily with food.

Sponsors & Collaborators

  • Government of Western Australia, Department of Health

    collaborator UNKNOWN

  • Western Australia AIDS Council

    collaborator UNKNOWN

  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • David Cooper, MD · The Kirby Institute, UNSW Sydney

  • Andrew Grulich, MBBS, MSc (Epid), PhD · The Kirby Institute, UNSW Sydney

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-16
Primary Completion
2019-04-30
Completion
2020-07-20

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03327155 on ClinicalTrials.gov