Western Australian Pre-exposure Prophylaxis for HIV Implementation Trial

• Status: Completed
• Trial end date: 2020-07-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kirby Institute
• Collaborators: Government of Western Australia, Department of Health; Western Australia AIDS Council
• Treatments: Emtricitabine; Tenofovir

Criteria

Inclusion Criteria:

1. HIV negative at enrolment, with a negative HIV test result conducted at the enrolment clinic within seven days of initiating PrEP

2. At high and ongoing risk for acquiring HIV infection [as defined by Behavioural Eligibility criteria in the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) HIV PrEP Clinical Guidelines]

3. Aged 18 years or over

4. Live in WA or visit WA enough to attend clinics for follow-up assessments

5. Willing and able to provide informed consent

6. Medicare ineligible individuals may be enrolled if the clinical service is able to cover the costs of monitoring of the patient

Exclusion Criteria:

1. HIV-1 infected or has symptoms consistent with acute viral infection (If HIV positive status is not confirmed by testing, delay starting PrEP for at least one month and reconfirm negative HIV-1 status)

2. Having an estimated creatinine clearance (glomerular filtration rate [eGFR]) <60ml/min

3. Having or developing clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort, and weakness)

4. Concurrently taking a nephrotoxic agent (e.g., high-dose non-steroidal anti-inflammatory drugs / NSAIDs)

5. Allergic to TDF and/or FTC (based on self-report or recorded)

6. Concurrently taking prescribed products containing FTC or TDF including ATRIPLA®, COMPLERA®, EMTRIVA, STRIBILD®, VIREAD, TAF (tenofovir alafenamide), GENVOYA, DESCOVY; other drugs containing lamivudine; HEPSERA

7. Factors or conditions that may compromise a participant's access to health services for follow-up (incarceration or planned relocation and potential absence from Western Australia)