Status:
COMPLETED
PrEP Demonstration Project (PRELUDE Study)
Lead Sponsor:
Kirby Institute
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 practi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 14 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2017
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT02206555
Start Date
November 14 2014
End Date
December 20 2017
Last Update
December 2 2019
Active Locations (5)
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1
RPA Sexual Health
Camperdown, New South Wales, Australia, 2050
2
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia, 2010
3
St Vincent's Hospital HIV, Immunology and Infectious Disease Unit
Darlinghurst, New South Wales, Australia, 2010
4
Western Sydney Sexual Health Centre
Parramatta, New South Wales, Australia, 2150