Clinical and health systems research |Clinical Trials

About the research study

The long-term aim of this research study is to investigate whether HIV eradication is possible. The use of combination antiretroviral therapy (cART) for the treatment of HIV has resulted in a significant improvement in the quality of life for individuals infected with HIV.  However, cART cannot cure HIV and is a lifelong treatment.

The major obstacle to HIV eradication is the persistence of latently infected resting memory T cells. These latently infected cells can live for a very long time. If cART is stopped, the virus from these latently infected cells can be “switched on”, re-establishing high levels of infection. Understanding how latency is established, is crucial for the development of strategies to treat and cure HIV.  
 

Am I eligible to participate?

Inclusion criteria:

• If you are over 18 years of age;
• If your weight is ≥ 50kg;
• Ability to provide informed consent;
• Documented HIV-1 infection (antibody positive or detectable plasma HIV-1 RNA);
• HIV RNA in plasma <50 copies/ml over the last 3 years (excluding single episodes of 50-500 if the subsequent HIV plasma RNA was <50 copies/mL);
• Receiving combination ART with plasma HIV RNA <50 copies/mL for >3 years;
• CD4+ T cell count > 350/uL at screening;

Exclusion criteria:

• Unwillingness to follow protocol requirements;
• Blood coagulation disorder;
• If you are pregnant or breast feeding;
• If you have an allergy to local anaesthetic;
• Previous use of histone deacetylase inhibitors or other latency reversing agents in the last 2 years;
   

Contact

This study is currently open for recruitment. If you meet the above criteria and are interested in participating, please contact:

Infectious Diseases Clinical Research Unit – Alfred Hospital
Clinical Research Team
(03) 9076 6908
clinresearch@alfred.org.au

What to expect during the study

Study Procedure

This study will involve the collection of blood cells by one of two methods:
The first procedure is called “leukapheresis”. It involves taking large amounts of blood out of one vein, passing that blood through a special cell separator which removes the T cells, and returning the remaining blood into a separate vein. Leukapheresis has been used safely in clinical practice for over 25 years and is used to obtain white cells for transplantation or to decrease very high numbers of white blood cells.

The second procedure involves collecting a large volume of blood (up to 150mL or 7.5 tablespoons) from one arm vein and storing it in several blood tubes, like a normal blood test.

You will only be required to undergo ONE of the above procedures.

Participant Requirements

The number of visits required will vary depending on your choice of procedure you consent to.

The first visit is mandatory for both procedures. This is referred to as the screening visit and will take about half an hour. This visit will confirm whether you are eligible to participate in the study. It involves the following:

• collection of your medical history (including HIV history) pathology results, demographic details
• collection of blood for routine clinical blood tests
• pregnancy test (female only)
• signing the consent form

However, if you are eligible and consent to the leukapheresis option, the study team will arrange an education session with a specialist haematology nurse (apheresis nurse) who will explain and go through the procedure details with you.

This visit is expected to take about an hour. The leukapheresis appointment will be booked by the study team after confirmation of eligibility, screening test results and vein assessment.

The leukapheresis visit will occur in The Alfred Apheresis unit and is expected to take between 3 – 4 hours.

Principal investigator

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