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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02870790
Other study ID # HEPP1511
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2016
Est. completion date October 2020

Study information

Verified date February 2021
Source Kirby Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A new NSW Ministry of Health HIV Strategy released on 1 December 2015 aims for the virtual elimination of HIV transmission in NSW by 2020. 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). 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, injecting drug users, and transgender men and women. The drug will be used according to existing NSW Ministry of Health Guidelines. By rapidly rolling out this new intervention over a 12 month period, and following participants for two years on treatments, a reduction of about 50% in new HIV diagnoses in NSW is expected. The study aims to assess the incidence of HIV among PrEP study participants and measure the population-level impact of the rapid roll-out of PrEP on HIV diagnoses among GBM in NSW over a two-year period. It will also evaluate the rate of PrEP uptake among high risk GBM in NSW, assess the incidence of STI (gonorrhoea, chlamydia and infectious syphilis) among people prescribed PrEP and measure the effect of the rapid roll-out of PrEP on the overall number of notifications of gonorrhoea, chlamydia and infectious syphilis in NSW, describe patterns of PrEP use and medication adherence, and monitor behavioural risk practices among PrEP users. The main population group will be more than 3700 gay men at high risk of HIV infection. All procedures of this study are guided by the NSW Guidelines on PrEP. Protocol Co-Chairs Professor David Cooper, Professor Andrew Grulich. Project Manager: Barbara Yeung


Recruitment information / eligibility

Status Completed
Enrollment 9733
Est. completion date October 2020
Est. primary completion date March 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - HIV negative at enrolment, with a negative HIV test result documented within seven days of initiating PrEP - At high and ongoing risk for acquiring HIV infection through sexual exposure (as defined by Behavioural Eligibility criteria presented in Appendix II and online Risk Assessment Questionnaire in Appendix III), OR previously a PrELUDE study participant - Aged 18 years or over - Live in NSW or ACT or visit NSW or ACT 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 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 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 NSW or ACT). Behavioural eligibility criteria as per NSW PrEP guidelines.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TDF/FTC
one pill daily

Locations

Country Name City State
Australia Albury Sexual Health Service Albury New South Wales
Australia Fountain Street General Practice Alexandria New South Wales
Australia Holdsworth House Byron Bay Byron Bay New South Wales
Australia RPA Sexual Health Camperdown New South Wales
Australia Canberra Sexual Health Centre Canberra Australian Capital Territory
Australia Interchange General Practice Canberra Australian Capital Territory
Australia Coffs Harbour Sexual Health Clinic Coffs harbour New South Wales
Australia St Vincent's Hospital HIV, Immunology and Infectious Disease Unit Darlinghurst New South Wales
Australia Dubbo Sexual Health Dubbo New South Wales
Australia Dr Doong's Surgery Enfield New South Wales
Australia Holden Street Gosford Gosford New South Wales
Australia Illawarra Shoalhaven Sexual Health Illawarra New South Wales
Australia Short Street Clinic Kogarah New South Wales
Australia Lismore Sexual Health Clinic - Northen Rivers Area Health Service Lismore New South Wales
Australia Liverpool Sexual Health Clinic Liverpool New South Wales
Australia Hunter New England Sexual Health Services Newcastle New South Wales
Australia St Leonards Medical Centre North Sydney New South Wales
Australia Orange Sexual Health Orange New South Wales
Australia Western Sydney Sexual Health Centre Parramatta New South Wales
Australia Macleay Street Medical Practice Potts Point New South Wales
Australia Crown Street Medical Centre Surry Hills New South Wales
Australia The Albion Centre Surry Hills New South Wales
Australia Clinic 16, Royal North Shore Hospital Sydney New South Wales
Australia East Sydney Doctors Sydney New South Wales
Australia Holdsworth House Medical Practice Sydney New South Wales
Australia Kirketon Road Centre Sydney New South Wales
Australia Nepean Sexual Health and HIV Clinic Sydney New South Wales
Australia Sydney Sexual Health Centre Sydney New South Wales
Australia Taylor Square Private Clinic Sydney New South Wales
Australia Brookong Centre Sexual Health Centre Wagga Wagga New South Wales
Australia Green Square Health Waterloo New South Wales

Sponsors (1)

Lead Sponsor Collaborator
Kirby Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of HIV infection per 100 person years among study participants 24 months of follow-up
Primary Number of HIV diagnoses among gay and bisexual men notified to the NSW Ministry of Health. 24 months of follow-up
Secondary Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants 24 months of follow-up
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