Status:
COMPLETED
Western Australian Pre-exposure Prophylaxis for HIV Implementation Trial
Lead Sponsor:
Kirby Institute
Collaborating Sponsors:
Government of Western Australia, Department of Health
Western Australia AIDS Council
Conditions:
HIV Prevention
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 transmis...
Detailed Description
The Australian seventh National HIV strategy (2014-2017) aims to reduce the incidence of HIV and to work towards the virtual elimination of HIV transmission in Australia by 2020. This extraordinary go...
Eligibility Criteria
Inclusion
- HIV negative at enrolment, with a negative HIV test result conducted at the enrolment clinic within seven days of initiating PrEP
- At high and ongoing risk for acquiring HIV infection \[as defined by Behavioural Eligibility criteria in the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) HIV PrEP Clinical Guidelines\]
- Aged 18 years or over
- Live in WA or visit WA enough to attend clinics for follow-up assessments
- Willing and able to provide informed consent
- Medicare ineligible individuals may be enrolled if the clinical service is able to cover the costs of monitoring of the patient
Exclusion
- 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)
- Having an estimated creatinine clearance (glomerular filtration rate \[eGFR\]) \<60ml/min
- Having or developing clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort, and weakness)
- Concurrently taking a nephrotoxic agent (e.g., high-dose non-steroidal anti-inflammatory drugs / NSAIDs)
- Allergic to TDF and/or FTC (based on self-report or recorded)
- Concurrently taking prescribed products containing FTC or TDF including ATRIPLA®, COMPLERA®, EMTRIVA, STRIBILD®, VIREAD, TAF (tenofovir alafenamide), GENVOYA, DESCOVY; other drugs containing lamivudine; HEPSERA
- 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)
Key Trial Info
Start Date :
November 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2020
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT03327155
Start Date
November 16 2017
End Date
July 20 2020
Last Update
September 4 2020
Active Locations (4)
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1
South Terrace Sexual Health Clinic
Fremantle, Western Australia, Australia, 6160
2
GP on Beaufort
Mount Lawley, Western Australia, Australia, 6050
3
Royal Perth Hospital Sexual Health Clinic
Perth, Western Australia, Australia, 6000
4
M Clinic
Perth, Western Australia, Australia, 6005