A5337: Sirolimus Study


Safety and Efficacy of Sirolimus for HIV Reservoir Reduction in Individuals on Suppressive Antiretroviral Therapy

Brief Description:

When a person becomes infected with HIV (the virus that causes AIDS), his/her immune system (the system that helps fight infection) is weakened (partly because the number of CD4+ cells goes down). Despite successful treatment with antiretroviral therapy (ART), latent reservoirs (infected cells that are not actively producing HIV) remain in the blood and contribute to a process called immune system activation and inflammation in the body. This may contribute to HIV persisting in cells in your body even though you are taking medications to treat HIV. This study is being done to see if a medication, sirolimus, can help decrease this immune system activation and inflammation. Sirolimus is a medication approved by the Food and Drug Administration (FDA) to prevent complications after some kidney transplants and stem cell transplants and as a treatment for certain kinds of cancers in HIV-infected patients.

Purpose of this Study: 

  • To find out about the safety and tolerability of sirolimus in people with HIV infection who are also being treated with HIV medications
  • To see if  sirolimus will decrease inflammation and immune activation in the body; whether sirolimus will change the level of HIV in your blood; and how sirolimus interacts with ART in the blood. 

Requirements to Enter the Study:

  • HIV-infected man or woman, at least 18 years. Women who are capable of having a baby must agree to use effective contraception before, during and at least 12 weeks after taking sirolimus.
  • Taking anti-HIV medications that have controlled your viral load for 2 or more years. Protease inhibiters and cobisistat are not allowed on this study.
  • No vaccinations in the past 14 days.
  • Have a CD4 cell      count of at least 400 cells/mm3.
  • No active Hepatitis B or C infection or      tuberculosis.
  • No recent condition requiring hospitalizations
  • No treatment for herpes zoster or      varicella zoster in the past 3 months  

Talk to your study staff for a complete list of inclusion/exclusion criteria

Treatment: You must be taking and planning to continue your current anti-HIV medications. These medications will not be supplied through this study.

During this study you will take sirolimus for 20 weeks. Your dose of sirolimus will depend upon your weight, the HIV medications you are taking and the amount of sirolimus measured in your blood. The amount of sirolimus will be measured in your blood twice a week until your level is between 5 and 10 ng/mL for 2 consecutive blood draws. The study doctor may need to adjust your sirolimus dose based upon the results of the blood tests. 

Duration of Study: You will participate in the study for 44 weeks.  This will include:

  • 9 study visits
  • Up to 9 blood draw only visits to check your sirolimus levels.