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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03327155




Registration number
NCT03327155
Ethics application status
Date submitted
8/09/2017
Date registered
31/10/2017
Date last updated
12/05/2020

Titles & IDs
Public title
Western Australian Pre-exposure Prophylaxis for HIV Implementation Trial
Scientific title
Western Australian Pre-exposure Prophylaxis for HIV Implementation Trial
Secondary ID [1] 0 0
HEPP1701
Universal Trial Number (UTN)
Trial acronym
PrEPIT-WA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Prevention 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC)

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


Treatment: Drugs: Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC)
One tablet, containing 300mg of TDF and 200mg of FTC once daily with food.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
24 weeks after the last participant completed their last follow-up visit (Month 18 visit)
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
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 outcome [1] 0 0
Trends in test positivity of Sexually Transmitted Infections (STIs, gonorrhoea, chlamydia and infectious syphilis) among study participants - To calculate trends in test positivity of STI (gonorrhoea, chlamydia and infectious syphilis) among study participants, and describe changes over time
Timepoint [1] 0 0
24 weeks after the last participant completed their last follow-up visit (Month 18 visit)
Secondary outcome [2] 0 0
Number of enrollment to the study by clinic type - To measure in the four study sites
Timepoint [2] 0 0
up to 6 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Prevention
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
South Terrace Sexual Health Clinic - Fremantle
Recruitment hospital [2] 0 0
GP on Beaufort - Mount Lawley
Recruitment hospital [3] 0 0
Royal Perth Hospital Sexual Health Clinic - Perth
Recruitment hospital [4] 0 0
M Clinic - Perth
Recruitment postcode(s) [1] 0 0
6160 - Fremantle
Recruitment postcode(s) [2] 0 0
6050 - Mount Lawley
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment postcode(s) [4] 0 0
6005 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Government of Western Australia, Department of Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Western Australia AIDS Council
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03327155
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Cooper, MD
Address 0 0
The Kirby Institute, UNSW Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications