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PrEP Demonstration Project (PRELUDE Study) (PRELUDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02206555
Recruitment Status : Completed
First Posted : August 1, 2014
Last Update Posted : December 2, 2019
Information provided by (Responsible Party):
Kirby Institute

Brief 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). 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.

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.

Condition or disease Intervention/treatment Phase
HIV Drug: emtricitabine/tenofovir disoproxil fumarate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 327 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Implementation of HIV Preexposure Prophylaxis With Antiretroviral Medications Among People at High Risk for HIV Infection: A Demonstration Project
Actual Study Start Date : November 14, 2014
Actual Primary Completion Date : November 28, 2016
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Treatment group (TRUVADA)
Homosexual men and heterosexual men and women at high risk of HIV infection
Drug: emtricitabine/tenofovir disoproxil fumarate
Other Names:

Primary Outcome Measures :
  1. Time to accrual [ Time Frame: Approximately 18 months ]
    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)

  2. Seroconversion-free time on PrEP [ Time Frame: Approximately 18 months ]
    Seroconversion-free time on PrEP (Primary endpoint: feasibility of the process of PrEP delivery in health care settings in NSW)

  3. Time to TRUVADA discontinuation [ Time Frame: Approximately 18 months ]
    Time to TRUVADA discontinuation (primary endpoint: adherence)

  4. Prescribed doses taken [ Time Frame: Approximately 18 months ]
    Percentage of prescribed doses taken orally in the prescribed period (primary endpoint: adherence)

  5. Incidents of HIV seroconversion [ Time Frame: Approximately 24 months ]
    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)

  6. Incidents of rectal gonorrhea and chlamydia [ Time Frame: Approximately 18 months ]
    New rectal gonorrhoea and chlamydia infections (primary endpoint: behavioral effects of PrEP use)

  7. Serious adverse reactions [ Time Frame: Approximately 18 months ]
    (primary endpoint: safety and side effects)

  8. Adverse events [ Time Frame: Approximately 18 months ]
    Any adverse events leading to interruption or discontinuation of the study product (TRUVADA) (primary endpoint: safety and side effects)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02206555

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Australia, New South Wales
RPA Sexual Health
Camperdown, New South Wales, Australia, 2050
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia, 2010
St Vincent's Hospital HIV, Immunology and Infectious Disease Unit
Darlinghurst, New South Wales, Australia, 2010
Western Sydney Sexual Health Centre
Parramatta, New South Wales, Australia, 2150
Sydney Sexual Health Centre
Sydney, New South Wales, Australia, 2000
Sponsors and Collaborators
Kirby Institute
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Study Chair: Iryna Zablotska, MD, MPH, PhD The Kirby Institute for Infection and Immunity in Society
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kirby Institute Identifier: NCT02206555    
Other Study ID Numbers: HEPP 1403
14/098 ( Other Identifier: St Vincent's Hospital HREC )
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Keywords provided by Kirby Institute:
demonstration study
Additional relevant MeSH terms:
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Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents