None listed
Conditions
Brief summary
Medications, drugs and devices have to be approved for use by the Australian Federal Government. Truvada (tenofovir and emtricitabine) is approved in Australia for HIV management in people who are HIV-positive. Truvada has been recently approved by the FDA in the United States for PrEP in people who are HIV-negative, however it has not yet been approved in Australia for use as PrEP. New HIV prevention strategies are necessary in Australia because HIV infection rates continue to rise. HIV pre-exposure prophylaxis (PrEP), when given as a daily pill and coupled with the consistent use of condoms and regular checks for sexually transmitted infections including HIV, is effective in preventing HIV infection. Several overseas studies have shown that daily tenofovir, or daily Truvada (tenofovir and emtricitabine) reduces HIV transmission by about 44% in men who have sex with men (MSM) and by about 70% in heterosexual people at risk of becoming HIV positive. There has been further evidence to show that in MSM who take their Truvada PrEP medication in the prescribed manner, that is one pill every day, that their risk of HIV infection is reduced by 96%. So taking PrEP every day according to the instructions along with using other HIV prevention measures like condoms and regular HIV and sexually transmitted infection (STI) screening is the best way to reduce your chances of becoming infected with HIV. It is now important to examine the results of these PrEP clinical trials in the “real world” setting to show that PrEP is a feasible, safe and effective method for reducing the risk of HIV acquisition in the Queensland community. The QPrEP demonstration project will address this need.
Interventions
Intervention model: single group assignment
Masking: Open label
Primary Purpose: prevention
Drug: emtricitabine/tenofovir disoproxil fumarate
a) Name of intervention: emtricitabine (200mg)/tenofovir disoproxil fumarate(300mg) (Truvada)
b) Dose administered: One tablet once a day
c) Duration of administration: Up to 12 months
d) Mode of administration - oral tablet
Strategies to monitor adherence: follow up at 1,3,6,9 and 12 months including tablet count and client surveys at 1,6 and 12 months
Sponsors
Cairns and Hinterland Hospital and Health Service
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Men who have sex with men at risk of acquiring HIV due to high risk sexual practices. Willing and able to provide written informed consent. HIV negative at enrolment, medicare eligible, willing and able to partake in study procedures, fluent in English
Exclusion criteria
HIV infected or signs or symptoms of acute HIV infection, creatinine clearance <60ml/min, active clinically significant medical problems including active TB, poorly controlled cardiac disease, previous or currently diagnosed malignancy requiring further treatment. Hepatitis B surface antigen positive, current use of ART, including nucleoside analogues, non-neucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents, interferon or interleukein therapy any investigational agents that may interact or affect PrEP medication and any nephrotoxic agents. Mental health issues, memory loss or other cognitive impairment or intellectual disability that may compromise participant safety and/or regimen adherence. Factors/conditions that may compromise a participant's retention in the study. Unwilling to adhere to any of the required study procedures
Outcome results
None listed