The SATURN-HIV study was a double-blind, randomized controlled trial of 10mg daily rosuvastatin versus matching placebo with a primary outcome of common carotid artery IMT progression from 0 to 96 weeks. Secondary outcomes included 96-week changes in lipids and CAC score, as well as inflammation and metabolic outcomes. All participants were ≥18 years of age without known coronary disease or uncontrolled diabetes, and on stable ART for at least 3 months with HIV-1 RNA <1,000 copies/mL. Similarly to the JUPITER (Justification for the Use of Statins in Prevention-an Intervention Trial Evaluating Rosuvastatin) study in HIV-uninfected adults[10 (link)], we included participants with LDL-cholesterol ≤130mg/dL (≤3.36mmol/L) and evidence of increased inflammation and/or T-cell activation (high sensitivity C-reactive protein ≥2mg/L (≥19mmol/L) and/or CD8+CD38+HLA-DR+ T-cells ≥19%). Nineteen per cent CD8+CD38+HLA-DR+ is the median level of patients successfully treated with ART and the 75th percentile for HIV-uninfected controls at our site. Additional inclusion and exclusion criteria are listed in Supplemental Table 1 (Table, Supplemental Digital Content 1) . Randomization was stratified by use of protease inhibitors and by presence or absence of CAC at study screening. All participants provided written informed consent, and the study was approved by the Institutional Review Board of University Hospitals Case Medical Center (Cleveland, Ohio). The study was registered on the clinicaltrials.gov website (NCT01218802).
Self-reported demographics and medical history were obtained along with a targeted physical exam including height, weight, waist, and hip measurements. Blood was drawn after at least a 12-hour fast for glucose, insulin, and lipoproteins. HOMA-IR was calculated from the fasting glucose and insulin measurements[22 (link)]. Ten-year Framingham Risk Score was calculated using a published risk calculator[23 (link)]. HIV-1 RNA level and CD4+ cell count were obtained as part of routine clinical care. Study participants and their physicians were blinded to laboratory values measured for this study; however, they were not blinded from laboratory values checked for clinical purposes during the study period.
Self-reported demographics and medical history were obtained along with a targeted physical exam including height, weight, waist, and hip measurements. Blood was drawn after at least a 12-hour fast for glucose, insulin, and lipoproteins. HOMA-IR was calculated from the fasting glucose and insulin measurements[22 (link)]. Ten-year Framingham Risk Score was calculated using a published risk calculator[23 (link)]. HIV-1 RNA level and CD4+ cell count were obtained as part of routine clinical care. Study participants and their physicians were blinded to laboratory values measured for this study; however, they were not blinded from laboratory values checked for clinical purposes during the study period.
