Clinical and health systems research |Clinical Trials

About the research study

The long-term goal of this study is to 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 'goes to sleep' in immune system cells. We need to locate the cells where HIV is resting and measure how much HIV is there. This will help us to identify new medicines that might be able to 'wake up' the HIV. Since large numbers of blood cells are needed to find HIV in people who have undetectable HIV in their blood, a special procedure to obtain and isolate cells is needed. This procedure is called 'leukapheresis' and 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 rest of the blood back 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. 

This study is now closed to recruitment.

Am I eligible to participate?

Inclusion Criteria;

1. Age 18 years with documented HIV-1 infection (antibody positive or detectable plasma HIV-1 RNA)
2. 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)
3. Receiving combination ART with plasma HIV RNA <50 copies/mL for >3 years
4. CD4+ T cell count >350/uL at screening
5. Able to provide informed consent

Exclusion criteria;

1. Known anaemia (men with haematocrit <0.36 L/L, women with haematocrit <0.32 L/L) or contraindication to donating blood.
2. Blood coagulation disorder (including bleeding tendency or past problems with blood clots.
3. Inadequate venous access to allow cannulation for leukapheresis.

What will I have to do?

Leukapheresis.  You will require 2 visits to Alfred hospital.

The first visit takes about one hour and is a one-on-one education session with a specialist haematology nurse (an apheresis nurse), who will explain leukapheresis, and check that your veins are in good condition to undergo the procedure.

Leukapheresis is a procedure whereby blood will be taken by a needle placed in one arm and processed through a machine, which spins the blood so that the white blood cells will be separated out in the machine for purposes of this research and the rest of the blood will be returned through a needle in the other arm.

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