A5336

Emory-CDC HIV/AIDS Clinical Trials Unit

AIDS   Clinical Trials Group (ACTG): ACTG A5336

Title   of Study: A randomized pilot study of Ruxolitinib in antiretroviral treated   HIV infected adults

Brief   Description:

Antiretroviral   therapy (ART) reduces the ability of HIV-1 to produce more copies of itself   and brings the amount of HIV-1 in the blood to an undetectable level. However,   AET only works on HIV01 that can be reached in the body and is actively   producing more copies of itself. Despite successful treatment with ART,   latent resources (infected cell that are not actively producing HIV-1) remain   present in the body and may contribute to ongoing immune system activation.

Ruxolitinib   is an FDA-approved medication to treat myelofibrsis, a disorder not related   to HIV-1 infection in which bone marrow is replaced by scar (fibrosis)   tissue. Many of the cytokines (regulators of the body’s reaction to   infection, immune response and inflammation) affected by myelobfribosis are   also affected by HIV-1. Because Ruxolitinib reduces these cytotokines in   people with myelofribrosis, it is proposed that it may also reduce inflammation   in the bodies of people living with HIV-1 in whom the virus is suppressed by   ART.  Laboratory experiments have also   shown that ruxolitinib may reduce the ability

Inclusion/   Exclusion Criteria:

Abbreviated   List of Inclusion/Exclusion Criteria

  •   HIV 1 infected men and women at least 18 years of age and less   than 75 years
  •   Be continuous HIV 1 treatment for the last 2 years with   undetectable HIV-1 viral load and no plans to change the medications  for the 12 weeks of the study
  •   CD4 + T cell (immune cell) blood count 350 or higher
  •   No other medical conditions or taking any medication that would   be contraindicated for individuals taking the study medication

Treatment:

A total   of 60 individuals will participate in the study. Participants will be   randomly assigned to either A) receive 5 weeks of treatment with ruxolitinib   as a pill to be taken orally twice a day (40 individuals ) or B) no study   treatment (20 individuals).

Study   Duration:

All individuals   will participate in a study for up to 12 weeks

For   more information contact:

Ericka   R. Patrick, RN, MSN

404-616-6313

erpatri@emory.edu