High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Living With HIV

• Status: Completed
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin therapy (pravastatin 40mg daily) versus high-dose statin therapy (rosuvastatin 20-40mg daily) in HIV-infected persons taking antiretroviral therapy (ART) who have coronary heart disease (CHD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Donald Lloyd-Jones; Matthew Feinstein
• Treatments: Pravastatin; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• HIV-1 infection

• HIV RNA below the lower limit of assay detection within 12 months of study entry

• 1) Documented coronary heart disease (CHD): nonfatal MI, unrecognized MI, unstable angina pectoris, and/or stable angina pectoris, as defined by the American Heart Association Case Definitions for Acute Coronary Heart Disease in Epidemiology and Clinical Research Studies, OR Or (2) Documented 10-year ASCVD risk of 15% or greater based on the ACC/AHA ASCVD Risk Estimator

• Negative serum or urine pregnancy test

• Men and women age 18 to 75 years of age

Exclusion Criteria:

• Serious illness or AIDS-related complication within 21 days of screening requiring systemic treatment and/or hospitalization

• No coronary heart disease (CHD) and 10-year ASCVD risk <15.0%.

• Not currently receiving antiretroviral therapy or taking any of the following antiretroviral agents: atazanavir/ritonavir, lopinavir/ritonavir.

• History of statin intolerance leading to discontinuation, dose decrease, or change to less potent dose equivalent

• Statin absolute contraindication

• Current use of atorvastatin 20mg daily or greater or rosuvastatin 10mg daily or greater

• Chronic kidney disease stage 4 or greater (including dialysis)

• Systolic heart failure with last documented LVEF <35%

• Pregnant or breastfeeding

• Laboratory values obtained within 45 days prior to study entry:

LDL-c <80 mg/dl while not on statin or LDL-c <60 mg/dl while on statin ALT > 3 x Upper Limit of Normal (ULN) AST > 3 x ULN Creatinine kinase (CK) >3 x ULN (calculated creatinine clearance (CrCl) <50 mL/min, as estimated by the Cockcroft-Gault equation)

• Life expectancy <12 months

• Prior organ transplant

• Active malignancy

• Inflammatory muscle disease