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

NCT ID: NCT02841774

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2021-06-30

Brief 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).

Detailed Description

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.

Conditions

HIV Infection; Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moderate Intensity Group

pravastatin 40mg daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

Pravastatin

Intervention Type: DRUG

40mg daily (Weeks 2 - 14)

High Intensity Group

rosuvastatin 20 - 40 mg daily for 12 weeks

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

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

Interventions

Pravastatin

40mg daily (Weeks 2 - 14)

Intervention Type: DRUG

Rosuvastatin

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 Type: DRUG

Other Intervention Names

CRESTOR

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Matthew Feinstein

OTHER

Sponsor Role: lead

Responsible Party

Matthew Feinstein

Assistant Professor of Medicine and Preventive Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Donald Lloyd-Jones, MD

Role: STUDY_CHAIR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CSC01

Identifier Type: -

Identifier Source: org_study_id