Western Australian Pre-exposure Prophylaxis for HIV Implementation Trial

NCT03327155 | Completed Phase 3

• 1 other identifier: HEPP1701
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 4

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 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

Keywords

HIV prevention; PrEP

Outcome Measures

Primary Outcomes (2)

• Incidence of HIV infection per 100 person years among study participants

  Statistical analyses of risk of HIV seroconversion among individuals who were prescribed PrEP (as part of the study) will focus on estimating the risk of seroconversion per 100 person years after TDF/FTC prescription and the effect modifying role of non-adherence to the prescribed medication schedule.

  24 weeks after the last participant completed their last follow-up visit (Month 18 visit)

• Number of HIV diagnoses among gay and bisexual men notified to Western Australian Department of Health

  Number of diagnoses will be measured using routinely reported data from the Western Australia registry of HIV diagnoses

  number of HIV diagnoses in the 12 month period prior to the date of first recruitment will be compared to the annual number of HIV diagnoses in the 12 month period after the study is fully recruited

Secondary Outcomes (2)

• Trends in test positivity of Sexually Transmitted Infections (STIs, gonorrhoea, chlamydia and infectious syphilis) among study participants

  24 weeks after the last participant completed their last follow-up visit (Month 18 visit)

• Number of enrollment to the study by clinic type

  up to 6 months

Study Arms (1)

TDF/FTC (300mg/200mg) once daily

EXPERIMENTAL

Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) (300mg/200mg) on tablet once daily with food.

Drug: Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC)

Interventions

Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) DRUG

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

Also known as: TDF/FTC

TDF/FTC (300mg/200mg) once daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kirby Institute: lead
• Government of Western Australia, Department of Health: collaborator
• Western Australia AIDS Council: collaborator

Study Sites (4)

South Terrace Sexual Health Clinic

Fremantle, Western Australia, 6160, Australia

Location

GP on Beaufort

Mount Lawley, Western Australia, 6050, Australia

Location

Royal Perth Hospital Sexual Health Clinic

Perth, Western Australia, 6000, Australia

Location

M Clinic

Perth, Western Australia, 6005, Australia

Location

MeSH Terms

Interventions

Tenofovir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David Cooper, MD

  The Kirby Institute, UNSW Sydney

  STUDY CHAIR

• Andrew Grulich, MBBS, MSc (Epid), PhD

  The Kirby Institute, UNSW Sydney

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The study is proposed as implementation research to mimic the conditions that will occur when PrEP is rolled out at the population level. However, as the version of TDF/FTC used in this study, manufactured by Mylan, is not approved for use as PrEP in Australia, the study is conducted under the Clinical Trial Notification (CTN) scheme and within the CTN framework. After collection of consent and enrolment information, all follow-up information will be collected through electronic data capture to allow accurate and timely analyses.

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: October 31, 2017
• Study Start: November 16, 2017
• Primary Completion: April 30, 2019
• Study Completion: July 20, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-09

Locations

AU (4)