HIV Clinical Trials Register

Clinical Trials Register
Rationale
Process
Terminology
Updating The Clinical Trials Register
Frequently Asked Questions
Acknowledgements
Links

Clinical Trials Register
Yes = trial is occuring at that service. No = trial is not being run at that service. Open = Trial is open to recruitment. Closed = Trial is closed to recruitment. Blue Text = link to further information on the trial or medical service / clinic.
HIV Clinical Trials KOALA STEAL STALWART SMART ESPRIT FLASH TOXIL 2 AIDS Medical Unit Brisbane No Yes Yes No Yes Yes Yes Cairns Sexual Health Clinic Yes Open Yes No No Yes Closed No Yes Gladstone Road Medical Centre Brisbane Yes Yes Yes Yes Yes Yes No Gold Coast Sexual Health Clinic No Yes Yes Yes Yes Yes Yes HIV & Sexual Health Service Sunshine Coast Yes Closed Yes No No Yes Yes Closed No Royal Brisbane Hospital Wattlebrae No Yes No Yes Closed No No No Centres may be running additional trials associated with other HIV drug companies. Some centres are also involved in ongoing observational studies
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Rationale
Welcome to the Queensland HIV Clinical Trials Register. This HIV Clinical Trials Register provides a focal point for Queensland's investment in HIV clinical trials and supports and facilitates collaboration between clinical sites. Through doing this, the site provides an information conduit between scientists, clinicians, community organisations and clients. It is hoped that through enhancing awareness of the range and type of clinical trials undertaken in Queensland, greater participation by clients and clinicians may be encouraged, facilitating improved treatment access for individuals with HIV. This HIV Clinical Trials Register provides information on the range of clinical trials undertaken in Queensland and the range of sites currently undertaking those trials. Where possible, each trial and each site is linked to that organisation's own website.
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Process
Sometimes the trial may be promoted by the clinic and the client can then ask the nurse or doctor about it. The nurse or doctor may suggest it to the client. The client will be provided with a detailed explanation of the trial. It is always the choice of the client to become involved in a clinical trial. Please note: Certain trials may not be appropriate for some clients. The trial nurse or doctor can explain reasons for this.
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Terminology
CRF	Case Report From- the folder that we write all the patients data in.
CRA	Clinical Research Associate - usually the person from the sponsor company who comes to monitor the CRF's.
Open Label	This means we know what drug the patient is getting.
Closed Label/ Blinded	This means that we don't know the drug the patient is getting.
Double Blinded	When neither the study staff nor the patient knows which drug they are getting. In these trials a central person/computer determines who gets what. Investigators can always find out what their patient is getting in an emergency.
Multi Centre Trial	This is a trial being performed at a number of sites. The other sites could be in a different hospital town or county.
Patients Numbers	Are determined by the statistical needs of the study to prove something.
DCF	Data Clarification From - a form sent when the data is wrong, doesn't match up with pervious entries or does not make sense. Eg putting pounds instead of kilograms, or saying the patient is male then doing pregnancy tests.
Protocol	The manual of how the study is to work. Must be approved by the ethics committee before a site can recruit patients.
Site File	Where all the regulatory documents are kept.
Phase III	Performed to gather more data and prove the drug works so that it can be registered with the FDA for use.
FDA	Food & Drug Administration
Informed Consent	The right to say No to a Clinical Trial.
Ethics Committee	Approved before it can go ahead.
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Updating The Clinical Trials Register
Use the online form to update our Clinical Trials Register here. Download a fax back form to update our Clinical Trial Register here.
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Frequently Asked Questions
How much does it cost? There is no cost to the client involved in a clinical trial. Do I have to see the doctor / clinic more? Depending on the research there may be 2-4 extra visits per year as well as some extra tests. This largely -depends on the trial though and all expectations would be clearly communicated to the client before any trial began. How long does the study go for? It depends on the particular trial. Each trial goes for a set period of time. Sometimes the trials get extended. The length of the trial will be outlined by the trials nurse before the trial begins. What happens if I get side effects or have to stop taking the trial drugs? If get side effects occur you are switched to another drug. All options are carefully considered and explained by the trials nurse. What if I move cities/states…will I be able to continue on the trial? Your clinic can check with clinic you are going to and see if they are doing the trial. If they do, then you can continue with trial. The trial nurse may be able to suggest locations where the trial is occurring so the client can continue.
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Acknowledgements
The HIV & HCV Education Projects would like to thank all the individuals and health care professionals who have taken their time to support this clinical trials register.
Links
ASHM Directory of HIV, hepatitis & related services The National Centre in HIV Epidemiology and Clinical Research Is one of Australia's leading medical research centre's and is recognised internationally as a leader in the field of research into HIV/AIDS and viral hepatitis. The Australian Research Centre in Sex, Health and Society (ARCSHS) Was established as the Centre for the Study of Sexually Transmissible Diseases in October 1992 as an independent research unit within the Faculty of Health Sciences. ARCSHS has a multi-disciplinary team of staff with qualifications and expertise in psychology, anthropology, sociology, public health, health promotion, methodology, epidemiology, education, women's health, consumer advocacy and health policy Australian Government Department for Health & Ageing Australia’s health system is world class, supporting universal and affordable access to high quality medical, pharmaceutical and hospital services, while helping people to stay healthy through health promotion and disease prevention activities. Queensland Positive People Part of a national & international network of people living with HIV & AIDS Queensland Aids Council The Queensland AIDS Council (QuAC) is a community-based organisation sponsored by Queensland Health responsible for providing education, advocacy and support for those living with or affected by HIV/AIDS in Queensland. AIDS Medical Unit Brisbane Community-based HIV medical and nursing management for those people infected and affected by HIV/AIDS. Cairns Sexual Health Clinic Cairns Sexual Health Service providing HIV specialist medical care and treatment testing. In addition treatment of sexually transmissible infections - free anonymous service Gold Coast Sexual Health Clinic Gold Coast Sexual Health Service providing HIV specialist medical care and treatment testing. In addition treatment of sexually transmissible infections - free anonymous service HIV & Sexual Health Service Sunshine Coast Sunshine Coast Sexual Health Service providing HIV specialist medical care and treatment testing. In addition treatment of sexually transmissible infections - free anonymous service Ozcare Ozcare is a leading not for profit organisation that provides a wide range of health and community services throughout Queensland. With over 185 services available, operations extend from Port Douglas in the far north, across to Mt Isa in the west and down to Burleigh Heads on the Gold Coast.
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