A5336: Ruxolitinib to Reduce Inflammation

A Randomized, Pilot Study of Ruxolitinib in Antiretroviral-Treated HIV-Infected Adults

Study Description

Chronic systemic inflammation and immune activation are known key contributors to end-stage organ, age-related diseases in individuals living with HIV.  Not only can this lead to decreased survival rates, it can also greatly affect the quality of life for those who are virologically suppressed while on antiretroviral treatment (ART) for long periods of time. As ACTG Network researchers continue to investigate ways to reduce inflammation caused by HIV, it is becoming more and more common to test drugs used to treat other inflammatory conditions such as rheumatoid arthritis and myelofibrosis. If a currently approved FDA drug can be shown to be effective in inhibiting inflammation in HIV suppressed participants on ART, these strategies could be implemented in order to mitigate or delay the emergence of serious age-related conditions. One such drug that has this potential is ruxolitinib, a tyrosine kinase inhibitor that has primarily been used to treat intermediate and high-risk myelofibrosis, a disorder disrupting the normal production of blood cells in bone marrow resulting in extreme inflammation, and polycythemia vera, a disorder producing excess blood cells. Since ruxolitinib was proven to reduce this inflammation, this led investigators to consider that it may also have a similar effect in those living with HIV. To that end, A5336: A Randomized, Pilot Study of Ruxolitinib in Antiretroviral-Treated HIV-Infected Adults was recently launched and will be led by Study Co-Chairs, Vincent Marconi, MD, Clinical Investigator and Jeffrey Lennox, MD, Co-Principal Investigator, at our Emory University Clinical Trials Unit in Atlanta, GA.

“A5336 is another in a series of first proof-of-concept, safety and tolerability, Phase II studies like A5337 and A5314 to use a novel therapeutic strategy to decrease harmful inflammation and combat persistent infection,” said Dr. Marconi. “This trial is designed to assess whether ruxolitinib can be safe, well-tolerated and effectively reduce inflammation for individuals with virologic suppression on ART. Additionally, there is some hope that reducing inflammation could also help reduce the HIV reservoir.”

More information about A5336

Ruxolitinib is an FDA-approved medication which reduces cytokines (regulators of the body’s reaction to infection, immune response, and inflammation) in people with a bone marrow disease. A5336 will study ruxolitinib to see if it might also reduce inflammation in HIV-infected people in whom the virus is suppressed by ART. Laboratory experiments have also shown that ruxolitinib may reduce the ability of HIV to produce more copies of itself.

Why is this study being done?

  • To learn about the safety and tolerability of ruxolitinib in people with HIV infection who have an undetectable HIV viral load.
  • To learn whether ruxolitinib will decrease inflammation and immune activation in the body.
  • To see if ruxolitinib will affect the level of HIV in the blood and how it interacts with anti-HIV medications in the blood.

Who can join?

  • HIV-infected men and women, 18 to 75 years old
  • On continuous HIV treatment for the past 2 years
  • Undetectable HIV viral load
  • CD4 cell count 350 or higher

What do I need to do in the study?
Participants will be randomly assigned (by chance) to either receive 5 weeks of treatment with ruxolitinib (taken by mouth twice a day) or no study treatment.

Participants must be taking and planning to continue their current anti-HIV medications.

All participants will be followed in the study for up to 12 weeks.

What treatments or drugs are involved with this study?
The study treatment that will be provided through the study is ruxolitinib.  HIV medications will not be supplied through this study.   

Study Status: