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

Matthew Feinstein10 enrolled

Overview

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).

HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin therapy versus high-dose statin therapy in HIV-infected persons taking antiretroviral therapy (ART) who have coronary heart disease (CHD). All subjects will have an initial 2-week run-in period with pravastatin 40mg daily (Week 0 to 2). Subjects not demonstrating significant toxicity at week 2 will then be randomized to rosuvastatin 20mg (high intensity dose group) versus continuing pravastatin 40mg daily (moderate intensity group) for 12 weeks (Weeks 2 to 14). At week 6, those in the rosuvastatin arm who do not demonstrate significant toxicity and whose LDL-c is \>60mg/dl and decreased by less than 25% compared with week 2 will then have doses increased to rosuvastatin 40mg.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infection Coronary Heart Disease

Interventions

PravastatinDRUG

40mg daily (Weeks 2 - 14)

RosuvastatinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Northwestern University

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Mean Percent Change in Fasting LDL-cholesterol

Mean percent change in fasting LDL-cholesterol at Week 2 and Week 14

Time frame: Week 2 and Week 14

Treatment-emergent Adverse Events

Number of Grade 3 or above adverse events

Time frame: 14 weeks

Data from ClinicalTrials.gov

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