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Clinical Trials

Details of current laboratory, social and clinical studies relating to HIV treatment and HIV cure are underway in Australia. Click on the links in the below listings for more information about eligibility and what study participation would involve.

This webpage was updated  on 30 August 2021

Illuminate HTE study

The Illuminate HTE study is evaluating the safety, tolerability and effectiveness of an investigational medication for people whose viral levels are no longer suppressed after trying several HIV treatments. It is a combination of an investigational medication and another medication that is already approved for use. Currently, a 3-drug combination is the standard for treating human immunodeficiency virus (HIV). This study aims to evaluate the safety and effectiveness of a 2-drug combination therapy taken once a day.

TITAN study

Combining a TLR9 agonist with broadly neutralizing antibodies for reservoir reduction and immunological control of HIV infection.

The TITAN study is being conducted across multiple countries including Australia, Denmark and the USA. It is exploring the effect of lefitolimod (a drug used in cancer therapy) and the broadly neutralizing antibodies 3BNC117 and 10-1074, on the HIV reservoir and HIV immune responses. Study participants will be will randomly allocated to one of four group and will received either:

  • Lefitolimod alone
  • Broadly neutralising antibodies alone
  • Lefitolimod and broadly neutralising antibodies
  • Placebo

After this, study participants will undergo a closely monitored 24-week ART interruption. There are strict criteria to restart ART to ensure participant safety.

Details

  • Principal investigator (Melbourne site):   Prof. Sharon Lewin, Doherty Institute
  • Australian co-ordinating investigator:  Dr James McMahon, Alfred Health
  • Recruitment location:   Alfred Health, Melbourne, Australia

NIVO-LD

This study is looking to explore the impact of Nivolumab (a drug used to treat cancers like melanoma) on immune responses to HIV infection.

There are two phases to this study. In the first phase, 18 people living with HIV on ART will receive one of three different doses of Nivolumab (at much lower doses to that given in cancer therapy) to determine which is the most effective dose.

In the second phase, 24 people living with HIV will be randomly selected to receive either the dose of Nivolumab determined in the first phase to be the most effective or a placebo. They will then undergo a closely monitored  5-week interruption of ART to see if Nivolumab is able to help control HIV without ART. There are strict criteria to restart ART to ensure participant safety.

Details

  • Principal investigator:  Prof. Sharon Lewin, Doherty Institute
  • Recruitment location:  Alfred Health, Melbourne, Australia

Leukapheresis

Large volume PBMC collection using leukapheresis to define HIV persistence in HIV infected adults

This study involves a detailed investigation of white blood cells from HIV+ participants, aiming to find which cell subsets contain virus and whether the virus found is infectious.

Details

  • Principal investigator:  Prof. Sharon Lewin, Doherty Institute
  • Recruitment location:  Melbourne, Australia

TRESAX study

T follicular helper REServoir in AXillary lymph nodes

This study will provide important information on how CD4 T follicular helper cells (TFH) are maintained and contribute to the HIV reservoir during antiretroviral therapy.

Details

  • Principal investigator:  Prof. Tony Kelleher, Kirby Institute
  • Recruitment location:  Sydney, Australia

HSTC

Impact of haematopoietic stem cell transplantation on HIV viral reservoirs in patients on combination antiretroviral therapy

This study investigates the effect of HSCT (for haematological issues) on the amount of HIV RNA and DNA in the CD4+ T cells of HIV+ participants.

Details

  • Principal investigator:  Prof. Sharon Lewin, Doherty Institute
  • Recruitment location:  Melbourne, Australia

iCHIP study

Effect of Immune Checkpoint Inhibitors on HIV persistence: An observational study among HIV patients with cancer

This study is looking to see if immune checkpoint drugs anti-PD1 or anti-CTLA4 can eliminate long lived forms of HIV. A total of 30 people living with HIV who have cancer and require a drug to block PD-1 or CTLA-4 or other immune checkpoint markers, will participate in this project.

  • Principal investigator:  Prof. Sharon Lewin, Doherty Institute
  • Recruitment location:  Melbourne and Sydney, Australia

HIV-SCT study

Blood and Tissue collection of patients with HIV-1 infection undergoing allogeneic haematopoietic Stem Cell Transplantation

This study follows people with HIV who have undergone allogeneic SCT to treat their haematological malignancy. The individual’s response to SCT will be characterised in regard to clinical outcomes, immune reconstitution, transplant complications, the HIV specific immune response and the impact on the HIV viral reservoir. It is only suitable for participants who have HIV and a cancer requiring SCT.

Details

 
  • Principal investigator:  Dr. Mark Polizzotto, The Kirby Institute
  • Recruitment location:  Sydney, Australia

HI-C study

HIV Immunity and Cancer cohort biobanking study

This study follows people with HIV who are receiving therapy to treat their cancer. The individual’s response to cancer treatment will be characterised in regard to clinical outcomes, immune reconstitution, transplant complications, the HIV specific immune response and the impact on the HIV viral reservoir. It is only suitable for participant who have HIV and a cancer requiring SCT.

  • Principal investigator:  Dr. Mark Polizzotto, The Kirby Institute
  • Recruitment location:  Sydney, Australia

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