Clinical and health systems research |Clinical Trials

About the research study

Finding a cure for HIV will provide a way for people with HIV to safely stop HIV medication and still keep the virus under control. The main reason why HIV cannot be cured at the moment is because HIV is able to hide in resting long-lived cells of the immune system. To achieve a cure for HIV, we need to develop therapies that are able to target and eliminate this pool of long-lived infected cells. One way to eliminate infected cells is through giving the immune system a boost using drugs called immune checkpoint blockers. These drugs were developed for different forms of cancer and have shown very good activity against some cancers. These drugs can block proteins called PD-1 and CTLA-4. Currently, only people with cancer are able to receive these medications. The aim of this study is to assess whether anti-PD1 or anti-CTLA4 can eliminate long lived forms of virus. A total of 30 individuals living with HIV in Victoria and New South Wales and who have cancer and require a drug to block PD-1 or CTLA-4 or other immune checkpoint markers, will participate in this project. 

Am I eligible to participate?

Inclusion Criteria;

1. Written informed consent
2. Age 18 years or older
3. Documented HIV-1 infection
4. On combination antiretroviral therapy
5. Plasma HIV RNA < 50 copies/mL at most recent measurement prior to screening.  Plasma HIV RNA 20 – 500 will not exclude participation if preceded by at least 2 undetectable copies
6. About to begin treatment with an anti-PD1, anti_CTLA4 or other T cell immunotherapy as treatment for malignancy

Exclusion criteria;

1. Lack of informed consent
2. Unwillingness to follow protocol requirements
3. Pregnant

What will I have to do?

Brief description of process for volunteer (about 100 words)

Participation in this study only requires involvement for up to 4 immunotherapy treatments.  You choose whether to give extra research blood samples during your third and fourth immunotherapy infusions only, or during each of the four infusions.

Prior to the start of your first infusion with an immunotherapy, and after enrolment into this study, 56 mL (nearly 3 tablespoons) of blood for research will be taken.

Extra blood will then be collected for research specific HIV assays at the following timepoints during treatment:

• Within 24 hours prior to each treatment, 38mL (nearly 2 tablespoons) in addition to any blood samples as ordered by your specialist
• 24 hrs post infusion, 38mL (nearly 2 tablespoons) and
• 7 days post infusion, 44 mL (more than 2 tablespoons)

After 8 weeks post your fourth infusion, 56 mL (nearly 3 tablespoons) of blood for research will be taken.

For more information contact

Infectious Diseases Clinical Research Unit – Alfred Hospital
Clinical Research Coordinator

(03) 9076 6908
clinresearch@alfred.org.au

Principal investigator

Prof Sharon Lewin
+61 3 8344 3159
sharon.lewin@unimelb.edu.au