HIV PreventionPhase 3PrEPIT-WANCT03327155
Western Australian Pre-exposure Prophylaxis for HIV Implementation Trial
A Phase 3 study testing Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) in people with HIV Prevention, run by Kirby Institute at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 4 sitesAustralia
- Study dates
- 16 Nov 2017to 20 Jul 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
South Terrace Sexual Health Clinic
Fremantle, Western Australia, 6160
GP on Beaufort
Mount Lawley, Western Australia, 6050
Royal Perth Hospital Sexual Health Clinic
Perth, Western Australia, 6000
M Clinic
Perth, Western Australia, 6005
About this study
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.
Read the 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 goal relies on two anti-retroviral therapy (ARV)-related interventions, in addition to traditional behavioural prevention. The first of these interventions, HIV treatment as prevention targeted at HIV positive people, has been ramped up over the last few years, and is approaching maximal levels of population impact. Despite this, new HIV diagnoses in Australia have been approximately constant over the last four years. Critical to the new strategy's success is the population-based, targeted roll-out of HIV PrEP. PrEP involves taking one pill daily of co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC). TDF/FTC has been extensively used in millions of people with HIV for more than 15 years.
This large-scale study aims for the rapid roll-out of TDF/FTC to individuals at high risk of HIV, who will comprise mostly gay and bisexual men (GBM) but will also include small numbers of heterosexuals, people who inject drugs, and transgender men and women. The drug will be used according to existing Australasian Society for HIV, Viral Hepatitis and Sexual Health (ASHM) HIV PrEP Clinical Guidelines.
By rapidly rolling out this new intervention as rapidly as feasible, and following participants for up to two years on treatments, we expect a reduction in new HIV diagnoses in WA due to decreased infection in the on-treatment cohort, and to the interruption of chains of transmission to others not receiving PrEP. The rapid and large-scale roll-out of PrEP is a critical component of working towards the virtual elimination of HIV transmission by 2020.
- Conditions
- HIV Prevention
- Being tested
- Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC)
- Keywords
- HIV prevention, PrEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC)Drug
Also called TDF/FTC
One tablet, containing 300mg of TDF and 200mg of FTC once daily with food.
| Study group | Role | What they receive |
|---|---|---|
| TDF/FTC (300mg/200mg) once daily | Experimental | Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) (300mg/200mg) on tablet once daily with food. Receives: Drug: Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
To calculate trends in test positivity of STI (gonorrhoea, chlamydia and infectious syphilis) among study participants, and describe changes over time
Measured: 24 weeks after the last participant completed their last follow-up visit (Month 18 visit)
Number of enrollment to the study by clinic type
To measure in the four study sites
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start16 Nov 2017
- Primary completion30 Apr 2019
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- Government of Western Australia, Department of Health, Western Australia AIDS Council
- Responsible party
- Sponsor
- Investigators
- David Cooper, MD, Study chair, The Kirby Institute, UNSW SydneyAndrew Grulich, MBBS, MSc (Epid), PhD, Study chair, The Kirby Institute, UNSW Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327155
- Sponsor's protocol ID
- HEPP1701
- Acronym
- PrEPIT-WA
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2017
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Western Australian Pre-exposure Prophylaxis for HIV Implementation Trial
- ClinicalTrials.gov ID
- NCT03327155
- Acronym / sponsor ID
- PrEPIT-WA / HEPP1701
- Conditions
- HIV Prevention
- Keywords
- HIV prevention, PrEP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- Government of Western Australia, Department of Health, Western Australia AIDS Council
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 goal relies on two anti-retroviral therapy (ARV)-related interventions, in addition to traditional behavioural prevention. The first of these interventions, HIV treatment as prevention targeted at HIV positive people, has been ramped up over the last few years, and is approaching maximal levels of population impact. Despite this, new HIV diagnoses in Australia have been approximately constant over the last four years. Critical to the new strategy's success is the population-based, targeted roll-out of HIV PrEP. PrEP involves taking one pill daily of co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC). TDF/FTC has been extensively used in millions of people with HIV for more than 15 years.
This large-scale study aims for the rapid roll-out of TDF/FTC to individuals at high risk of HIV, who will comprise mostly gay and bisexual men (GBM) but will also include small numbers of heterosexuals, people who inject drugs, and transgender men and women. The drug will be used according to existing Australasian Society for HIV, Viral Hepatitis and Sexual Health (ASHM) HIV PrEP Clinical Guidelines.
By rapidly rolling out this new intervention as rapidly as feasible, and following participants for up to two years on treatments, we expect a reduction in new HIV diagnoses in WA due to decreased infection in the on-treatment cohort, and to the interruption of chains of transmission to others not receiving PrEP. The rapid and large-scale roll-out of PrEP is a critical component of working towards the virtual elimination of HIV transmission by 2020.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| TDF/FTC (300mg/200mg) once daily | Experimental | Drug: Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC)Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) (300mg/200mg) on tablet once daily with food. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC)Also: TDF/FTCOne tablet, containing 300mg of TDF and 200mg of FTC once daily with food. | Drug | TDF/FTC (300mg/200mg) once daily |
Primary outcome
Incidence of HIV infection per 100 person years among study participants
Time frame: 24 weeks after the last participant completed their last follow-up visit (Month 18 visit)
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.
Number of HIV diagnoses among gay and bisexual men notified to Western Australian Department of Health
Time frame: 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
Number of diagnoses will be measured using routinely reported data from the Western Australia registry of HIV diagnoses
2 secondary outcomes
Trends in test positivity of Sexually Transmitted Infections (STIs, gonorrhoea, chlamydia and infectious syphilis) among study participants
Time frame: 24 weeks after the last participant completed their last follow-up visit (Month 18 visit)
Number of enrollment to the study by clinic type
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
Related trials for HIV Prevention
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruitingPhase 4
Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator
HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
Active, not recruiting
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
HIV Prevention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Cooper, MD study chair
The Kirby Institute, UNSW Sydney
Andrew Grulich, MBBS, MSc (Epid), PhD study chair
The Kirby Institute, UNSW Sydney
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) in people with HIV Prevention, run by Kirby Institute at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of HIV infection per 100 person years among study participants (time frame: 24 weeks after the last participant completed their last follow-up visit (Month 18 visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.