Safety and Efficacy of Sirolimus for HIV Reservoir Reduction in Individuals on Suppressive Antiretroviral Therapy
The purpose of this study was to find out about the safety of sirolimus in individuals with HIV infection who were also being treated with ART. The investigators wanted to learn whether sirolimus decreases inflammation and immune activation in the body; whether sirolimus changes 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 had 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.
• HIV-1 infection
• On continuous ART for ≥24 months prior to study entry.
• CD4+ cell count ≥350 cells/mm\^3
• Plasma HIV-1 RNA below the level of quantification for ≥24 months.
• White blood cell (WBC) ≥3000/mm\^3
• Platelet count ≥125,000/mm\^3
• Absolute neutrophil count (ANC) \>1300/mm\^3
• Aspartate aminotransferase (AST) \<1.25 x upper limit of normal (ULN)
• Alanine aminotransferase (ALT) \<1.25 x ULN
• Calculated creatinine clearance (CrCl) ≥60 mL/min
• Fasting or non-fasting triglyceride level ≤350 mg/dL
• Fasting or non-fasting LDL \<160 mg/dL
• Urine protein to urine creatinine ratio ≤1 g/g from random urine collection