a study on HIV/AIDS
The purpose of this study is to find out about the safety of sirolimus in individuals with HIV infection who are also being treated with ART. The investigators want to learn whether sirolimus will decrease inflammation and immune activation in the body; whether sirolimus will change the level of HIV in the participants' blood; and how sirolimus interacts with ART in the blood. Sirolimus is approved by the Food and Drug Administration (FDA) to prevent organ rejection in patients aged 13 years and older receiving kidney transplants. Sirolimus has also been used for the prevention of complications after stem cell transplants and as a treatment for certain kinds of cancers in HIV-infected patients.
Safety and Efficacy of Sirolimus for HIV Reservoir Reduction in Individuals on Suppressive Antiretroviral Therapy
HIV-1 Infection Sirolimus Everolimus
Open to people ages 18 years and up
NOTE: The term "licensed" refers to a US FDA-approved kit, which is required for all investigational new drug (IND) studies.
WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention)guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.
NOTE: Patient-reported history is acceptable documentation of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts, vasectomy, and menopause.
Females of reproductive potential who are participating in sexual activity that could lead to pregnancy must agree to initiate effective contraceptives before sirolimus therapy, continue use during sirolimus therapy, and maintain use for at least 12 weeks after sirolimus therapy has been stopped.
Female subjects and/or their male partners MUST agree to use appropriately at least one of the following:
Calculated creatinine clearance (CrCl) ≥60 mL/min as estimated by the Cockcroft-Gault equation:
For men, (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dL x 72) =CrCl (mL/min)*
NOTE: Prophylaxis must have been completed at least 48 weeks prior to study entry.
NOTE: Subjects who are HCV antibody negative within 90 days prior to study entry are eligible for the study. Those who are not taking HCV therapy and who are HCV antibody-positive but HCV RNA negative within 90 days prior to study entry are eligible for the study.
NOTE: If subjects receive influenza vaccination for routine clinical care during or prior to the screening visit, they may be rescreened 14 days after vaccination.
NOTE: Prior PI-based or cobicistat-boosted regimens are allowed.
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02440789.
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