High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Living With HIV
Condition: HIV Infection; Coronary Heart Disease
MeSH terms: Heart Diseases; Acute Coronary Syndrome; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Intervention: Pravastatin; Rosuvastatin
Intervention description: 40mg daily (Weeks 2 - 14); 20mg daily (Weeks 2 - 14); at Week 6, if AST, AST, and CK <+1.5 x ULN, and LDL-c is >60 and decreased by less than 25% compared with week 2, then dose will be increased to rosuvastatin 40mg daily
Intervention MeSH terms: Rosuvastatin Calcium; Pravastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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).
    

Eligibility 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