Kirby Institute launches HIV PrEP study in NSW

The Kirby Institute has launched a study examining the use of HIV treatment by HIV negative people to reduce their risk of acquiring the virus.

The PrELUDE Study (NSW PrEP Demonstration Project) is the largest study of its kind to be conducted in Australia. Researchers from the Kirby Institute will explore what it’s like for people who are HIV negative to take a daily dose of TRUVADA®, a two drug combination therapy currently used to treat HIV in Australia, as pre-exposure prophylaxis of HIV (PrEP).

“Several important clinical trials have established that PrEP is an effective HIV prevention strategy for both gay men and heterosexuals,” said Dr Iryna Zablotska-Manos, chief investigator of the study at the Kirby Institute. “But whether PrEP confers high rates of protection in real life situations and is a feasible strategy to implement still requires further investigation, and that is what we are seeking to do through PrELUDE.”

To date, TRUVADA® is the only antiretroviral medication that has been approved by the US Food and Drug Administration (FDA) for preventative use as PrEP among individuals at high risk for HIV. Although it is currently not licensed for this purpose in Australia, the NSW Government is committed through the NSW HIV Strategy 2012-2015 to considering how to most appropriately and efficiently implement PrEP as part of a combination approach to the prevention of HIV transmission.   

Researchers will enrol 300 people for the study with a focus on people at heightened risk of acquiring HIV.

Initially, the study will recruit participants in four large HIV and sexual health services in NSW which currently provide ARVs as treatment and as non-occupational post-exposure prophylaxis of HIV. These will include:

  • Royal Prince Alfred Sexual Health (RPASH)
  • St. Vincent’s Hospital (SVH)
  • Sydney Sexual Health Centre (SSHC)
  • Western Sydney Sexual Health Clinic

As recruitment evolves, other health providers in NSW will be engaged.

Stakeholder quotes:

“ACON has been monitoring with very high interest the research on PrEP*, including recent findings from the IPERGAY study in France and the PROUD study in the UK – both of which had convincing results.  The commencement of the trial in NSW is exciting for gay men who are looking for additional ways in which they may reduce HIV transmission risk and this trial will inform NSW’s next steps when it comes to PrEP implementation.  That’s why ACON warmly welcomes the Kirby Institute’s HIV PrEP study. We are confident that it will produce the same encouraging results here in Australia that we have seen overseas. Gay men have demonstrated over three decades they care about their own, and their partners’ health – acting to prevent HIV from escalating in the NSW community.  If found to be effective, ACON strongly believes that gay men should have access to the full range of proven prevention technologies, and the early indications are that PrEP offers a major risk reduction strategy for individuals at high risk of HIV”.  - Nicolas Parkhill, Chief Executive Officer, ACON


“The PrELUDE study is an exciting HIV prevention initiative. The Kirby Institute and NSW Ministry of Health are to be congratulated for progressing this critical prevention intervention for people at higher risk of HIV infection. Every HIV diagnosis is one too many and PrELUDE will assist in achieving an end to HIV transmission.” – Craig Cooper, Chief Executive Officer, Positive Life NSW

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Date published: 
Wednesday, 26 November 2014
Laurie Legere
+61 413 476 647