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PrEP Demonstration Project (PRELUDE Study)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Kirby Institute
Sponsor:
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT02206555
First received: July 28, 2014
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
HIV
Drug: emtricitabine/tenofovir disoproxil fumarate
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Kirby Institute:

Primary Outcome Measures:
  • Time to accrual [ Time Frame: Approximately 18 months ] [ Designated as safety issue: No ]
    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)

  • Seroconversion-free time on PrEP [ Time Frame: Approximately 18 months ] [ Designated as safety issue: No ]
    Seroconversion-free time on PrEP (Primary endpoint: feasibility of the process of PrEP delivery in health care settings in NSW)

  • Time to TRUVADA discontinuation [ Time Frame: Approximately 18 months ] [ Designated as safety issue: No ]
    Time to TRUVADA discontinuation (primary endpoint: adherence)

  • Prescribed doses taken [ Time Frame: Approximately 18 months ] [ Designated as safety issue: Yes ]
    Percentage of prescribed doses taken orally in the prescribed period (primary endpoint: adherence)

  • Incidents of HIV seroconversion [ Time Frame: Approximately 24 months ] [ Designated as safety issue: Yes ]
    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)

  • Incidents of rectal gonorrhea and chlamydia [ Time Frame: Approximately 18 months ] [ Designated as safety issue: Yes ]
    New rectal gonorrhoea and chlamydia infections (primary endpoint: behavioral effects of PrEP use)

  • Serious adverse reactions [ Time Frame: Approximately 18 months ] [ Designated as safety issue: Yes ]
    (primary endpoint: safety and side effects)

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


Estimated Enrollment: 400
Study Start Date: September 2014
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group (TRUVADA)
Homosexual men and heterosexual men and women at high risk of HIV infection
Drug: emtricitabine/tenofovir disoproxil fumarate
Other Names:
  • TRUVADA
  • FTC/TDF

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02206555

Locations
Australia, New South Wales
RPA Sexual Health Not yet recruiting
Camperdown, New South Wales, Australia, 2050
Contact: David Templeton, MBChB, PhD    + 61 2 9515 1200      
Principal Investigator: David Templeton, MBChB, PhD         
St Vincent's Hospital HIV, Immunology and Infectious Disease Unit Not yet recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Andrew Carr, MD    +61 2 8382 3707      
Contact: John McAlister, RN, MSc    +61 2 8382 3707      
Principal Investigator: Andrew Carr, MD         
Sub-Investigator: John McAlister, RN, MSc         
Western Sydney Sexual Health Centre Not yet recruiting
Parramatta, New South Wales, Australia, 2150
Contact: Catriona Ooi, MBBS, MMed    +61 2 9843 3124      
Principal Investigator: Catriona Ooi, MBBS, MMed         
Sydney Sexual Health Centre Not yet recruiting
Sydney, New South Wales, Australia, 2000
Contact: Anna McNulty, MBBS, MMed    +61 2 9382 7440      
Principal Investigator: Anna McNulty, MBBS, MMed         
Sponsors and Collaborators
Kirby Institute
Investigators
Study Chair: Iryna Zablotska, MD, MPH, PhD The Kirby Institute for Infection and Immunity in Society
  More Information

No publications provided

Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT02206555     History of Changes
Other Study ID Numbers: HEPP 1403, 14/098
Study First Received: July 28, 2014
Last Updated: July 30, 2014
Health Authority: Australia: Therapeutic Goods Administration

Keywords provided by Kirby Institute:
HIV
prevention
prophylaxis
antiretroviral
biomedical
bio-behavioural
evaluation
demonstration study

Additional relevant MeSH terms:
Emtricitabine
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014