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HIVPhase 4PRELUDENCT02206555

PrEP Demonstration Project (PRELUDE Study)

A Phase 4 study testing emtricitabine/tenofovir disoproxil fumarate in people with HIV, run by Kirby Institute at 5 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Significant increases in HIV diagnoses among gay and other homosexually active men, in Australia and internationally, have been observed since the late 1990s. The levels of high HIV risk sexual practices among gay men have also increased, particularly unprotected anal intercourse (UAI). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
emtricitabine/tenofovir disoproxil fumarate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
327 participants
Where
5 sitesAustralia
Study dates
14 Nov 2014to 20 Dec 2017
Phase
Phase 4
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • HIV negative at enrollment (per algorithm provided in protocol)
  • At high and ongoing risk for acquiring HIV infection (per algorithm provided in protocol)
  • Aged 18 years or over
  • Resident of NSW (or elsewhere in Australia if they visit NSW with sufficient frequency to allow participation)
  • Medicare eligible (to have Medicare coverage for the standard-of-care services)
  • Willing and able to provide informed consent
  • Willing and able to take part in all required study procedures
  • Proficiency in written and spoken English (necessary to complete attitude, behavioural and lifestyle surveys)

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 [GFR]) <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 tenofovir disoproxil fumarate and/or emtricitabine (based on self-report or recorded)
  • Concurrently taking prescribed products containing emtricitabine or tenofovir disoproxil fumarate including ATRIPLA®, COMPLERA®, EMTRIVA, STRIBILD®, VIREAD; other drugs containing lamivudine; HEPSERA
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  • Mental health issues, memory loss or other cognitive impairment or intellectual disability that may compromise participant safety and/or regimen adherence
  • Factors or conditions that may compromise a participant's retention in the study (incarceration, planned relocation or potential absence from NSW for a period of 3 months or longer during the course of the study)
  • Unwilling to adhere to any of the required study procedures
  • Currently breastfeeding
  • Note: Safety for infants exposed to TRUVADA during pregnancy is not fully assessed but no harm has been reported. Therefore, planning to become pregnant or currently being pregnant is not an exclusion criterion for this study. However, women who are pregnant should learn about the risks and benefits of TRUVADA to reduce the risk of acquiring HIV during their pregnancy. Site investigators will review the risks and benefits of TRUVADA and of potential HIV infection with pregnant women and women who plan to become pregnant.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Australia5 sites

  • RPA Sexual Health

    Camperdown, New South Wales, 2050

  • Holdsworth House Medical Practice

    Darlinghurst, New South Wales, 2010

  • St Vincent's Hospital HIV, Immunology and Infectious Disease Unit

    Darlinghurst, New South Wales, 2010

  • Western Sydney Sexual Health Centre

    Parramatta, New South Wales, 2150

  • Sydney Sexual Health Centre

    Sydney, New South Wales, 2000

Other trials in Australia

About this study

Official title: Implementation of HIV Preexposure Prophylaxis With Antiretroviral Medications Among People at High Risk for HIV Infection: A Demonstration Project

Significant increases in HIV diagnoses among gay and other homosexually active men, in Australia and internationally, have been observed since the late 1990s. The levels of high HIV risk sexual practices among gay men have also increased, particularly unprotected anal intercourse (UAI). Nationally, over three quarters of the new HIV infections diagnosed annually are among men who have sex with men (MSM). The proportion of heterosexual men and women among those diagnosed with HIV annually has also increased in recent years. Despite successes in some situations, HIV transmission has not been adequately reduced by the prevention methods available to those at risk, such as education, condoms, and treatment of sexually transmitted infections (STIs).

The effectiveness of daily oral antiretroviral medications (ARVs) as preexposure prophylaxis of HIV (PrEP) has now been established by clinical trials in both heterosexual adults and homosexual men. Whether PrEP confers high rates of protection in real life situations and is a feasible strategy to implement still requires further investigation. Through its "HIV prevention strategy 2015: New era," NSW Health committed to consider how to most appropriately and efficiently implement PrEP in line with evidence. This commitment translated in the support to this PrEP demonstration project.

Read more

This demonstration project is designed to evaluate the off-label provision of daily combination of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC, known as TRUVADA) as PrEP to a sample of sero-negative individuals at high risk for HIV infection in clinical settings in New South Wales. The project will inform policy development regarding primary HIV prevention with PrEP.

This is an open-label, single-arm treatment evaluation study. All consenting and eligible HIV negative participants will receive TRUVADA prescribed for daily administration orally. At each followup visit, the following procedures will be conducted: clinical evaluations/ procedures, laboratory evaluations/ procedures, testing for HIV, STIs, hepatic and renal function, assessment for adherence to the prescribed medication, side effects, eligibility for next TRUVADA prescription, and willingness to continue on PrEP.

As a study requirement, participants will be offered a self-administered assessment of behaviour, lifestyle and attitudes which will be conducted ideally within two and no more than seven days of the clinic visit in the participant's private space.

Analyses will include: the feasibility of PrEP delivery, adherence to the study medication, safety and tolerability, the effects of PrEP use on behavior, and statistical analyses of the risk of HIV seroconversion.

Conditions
HIV
Being tested
emtricitabine/tenofovir disoproxil fumarate
Keywords
HIV, prevention, prophylaxis, antiretroviral, biomedical, bio-behavioural, evaluation, demonstration study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • emtricitabine/tenofovir disoproxil fumarateDrug

    Also called TRUVADA, FTC/TDF

Study groups in NCT02206555
Study groupRoleWhat they receive
Treatment group (TRUVADA)ExperimentalHomosexual men and heterosexual men and women at high risk of HIV infection
Receives: Drug: emtricitabine/tenofovir disoproxil fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to accrual

    Time to accrual of 300 person-years of follow-up on TRUVADA. Each participant will receive TRUVADA for a maximum of 12 months, and will be followed for an additional three months after discontinuation. (Primary endpoint: feasibility of the process of PrEP delivery in health care settings in NSW)

    Measured: Approximately 18 months

  2. Seroconversion-free time on PrEP

    Seroconversion-free time on PrEP (Primary endpoint: feasibility of the process of PrEP delivery in health care settings in NSW)

    Measured: Approximately 18 months

  3. Time to TRUVADA discontinuation

    Time to TRUVADA discontinuation (primary endpoint: adherence)

    Measured: Approximately 18 months

  4. Prescribed doses taken

    Percentage of prescribed doses taken orally in the prescribed period (primary endpoint: adherence)

    Measured: Approximately 18 months

  5. Incidents of HIV seroconversion

    Incidence of HIV seroconversion among study participants during the course of their study participation and in six months following PrEP discontinuation (primary endpoint: safety and side effects)

    Measured: Approximately 24 months

  6. Incidents of rectal gonorrhea and chlamydia

    New rectal gonorrhoea and chlamydia infections (primary endpoint: behavioral effects of PrEP use)

    Measured: Approximately 18 months

  7. Serious adverse reactions

    (primary endpoint: safety and side effects)

    Measured: Approximately 18 months

  8. Adverse events

    Any adverse events leading to interruption or discontinuation of the study product (TRUVADA) (primary endpoint: safety and side effects)

    Measured: Approximately 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2014 (estimated)
  2. Study start14 Nov 2014
  3. Primary completion28 Nov 2016
  4. Study completion20 Dec 2017

Resources

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 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
327 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02206555
Sponsor's protocol ID
HEPP 1403
Other IDs
14/098
Acronym
PRELUDE
Status last verified
Nov 2019
First submitted
28 Jul 2014
Last updated
2 Dec 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Vaccher SJ, Marzinke MA, Templeton DJ, Haire BG, Ryder N, McNulty A, Foster R, Grulich AE, Zablotska IB; PRELUDE Study Team; NSW HIV Prevention Partnership Project. Predictors of Daily Adherence to HIV Pre-exposure Prophylaxis in Gay/Bisexual Men in the PRELUDE Demonstration Project. AIDS Behav. 2019 May;23(5):1287-1296. doi: 10.1007/s10461-018-2353-5.

    PubMed 30523489

  • Vaccher SJ, Gianacas C, Templeton DJ, Poynten IM, Haire BG, Ooi C, Foster R, McNulty A, Grulich AE, Zablotska IB; PRELUDE Study Team. Baseline Preferences for Daily, Event-Driven, or Periodic HIV Pre-Exposure Prophylaxis among Gay and Bisexual Men in the PRELUDE Demonstration Project. Front Public Health. 2017 Dec 15;5:341. doi: 10.3389/fpubh.2017.00341. eCollection 2017.

    PubMed 29326917

  • Vaccher S, Grulich A, McAllister J, Templeton DJ, Bloch M, McNulty A, Holden J, Poynten IM, Prestage G, Zablotska I; PRELUDE Study Team. Protocol for an open-label, single-arm trial of HIV pre-exposure prophylaxis (PrEP) among people at high risk of HIV infection: the NSW Demonstration Project PRELUDE. BMJ Open. 2016 Jun 20;6(6):e012179. doi: 10.1136/bmjopen-2016-012179.

    PubMed 27324719

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing emtricitabine/tenofovir disoproxil fumarate in people with HIV, run by Kirby Institute at 5 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 8 inclusion and 11 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 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Time to accrual (time frame: Approximately 18 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02206555, which also lists 3 linked publications.

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 2 Dec 2019.

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