Clinical Research & Trials

Janine Roney                Unit Manager    
                                    Ph: 9076 6908   
                                    Email:clinresearch@alfred.org.au 

Dr Julian Elliott              Head - Infectious Diseases Physician   

Dr James McMahon       Infectious Diseases Physician   

Clinical Research Co-ordinators: Michelle Hagenauer, Mellissa Bryant, Sally Price, Jill Garlick, Cath Downs, Nigel Pratt, Jess Costa, Andrea Morrow

Description of Service

The Infectious Diseases Clinical Research Unit conducts single and multi-centre investigator and industry-initiated studies. The studies vary in type such as;

  • Testing the efficacy and safety of new or novel drug treatments
  • Observational studies that aim to collect data from populations, and typically involve large numbers of participants followed for many years.
  • Specifics of a group at a single point in time.

The unit is based at the Alfred Hospital, and enjoys close links with other primary and tertiary health care providers with similar inteests, including: Melbourne Sexual Health Centre, tRoyal Melbourne Hospital, Monash Health and inner city practices: Prahran Market, Centre and Northside Clinics. We also collaborate closely with the Burnet Institute, Monash University, The Doherty Institute, The Baker IDI and in Sydney, the Kirby Institute.

Research Themes:

  • International multi-site clinical trial for new treatments in Infectious Diseases including: HIV, Hepatitis C, Influenza and Clostridium Difficile
  • Clinical trials in collaboration with the Doherty Institute in the field of HIV Cure
  • Leading or participating in multi-site surveillance and observational studies such as, FluCAN (The Influenza Complications Alert Network) and the Australian HIV Observational Database
  • Other studies in General Infectious Diseases as a member of the Australian Society for Infectious Diseases Clinical Research Network
  • Support for research implementation, monitoring and ethics applications for our collaborators
  • Other related Infectious Diseases Clinical Research

Key Studies Currently Recruiting:

DIORR – Dolutegravir Impacts on Residual viral Replication. Randomised placebo controlled trial of adding 8 weeks Dolutegravir (or placebo) to regimen of 40 participants. Aims to understand impact of Dolutegravir on residual viral replication in people with longterm virological suppression. Main inclusions are VL < 50 for 3 years (one blip allowed), CD4 > 350 for 12 months and no history of exposure to any integrase inhibitors. Therefore study targets patients on PI or NNRTI based regimens.

https://clinicaltrials.gov/ct2/show/NCT02500446

MK-1439-018 (Doravirine) naïve study. Comparing Doravirine 100mg daily to Darunavir/ritonavir (800 mg/100 mg) daily with an investigator selected backbone of TDF/FTC or ABC/3TC in participants naïve to antiretroviral therapy. Primary endpoint after 48 weeks treatment.

https://clinicaltrials.gov/ct2/show/NCT02275780

MK-1439A-024 (Doravirine) switch study. Open label switch RCT to compare continuing current PI + 2NRTI containing antiretroviral regimen or switch to single tablet Doravirine/3TC/TDF in virologically suppressed participants. Participants must be receiving their first or second PI based regimen without a history of prior virological failure.

https://clinicaltrials.gov/ct2/show/NCT02397096

New Attachment Inhibitor for Heavily Treatment Experienced Patients. Multi-arm Phase 3 study in people with virological failure and limited treatment options due to multi-class resistance to add the new attachment inhibitor BMS-663068 to an optimized background regimen.

https://clinicaltrials.gov/ct2/show/NCT02362503

If you are interested in participating in a clinical study register your interest at clinresearch@alfred.org.au or phone 90766908

You can also be placed on a contact list for future studies.

All potential participants in a study are provided with a Patient Information and Consent Form and are encouraged to talk to either their physician or to a member of the Clinical Research Unit before agreeing to be involved in a study.