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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841774
Recruitment Status : Active, not recruiting
First Posted : July 22, 2016
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Matthew Feinstein, Northwestern University

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).

Condition or disease Intervention/treatment Phase
HIV Infection Coronary Heart Disease Drug: Pravastatin Drug: Rosuvastatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Living With Human Immunodeficiency Virus (HILLCLIMBER)
Actual Study Start Date : November 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Moderate Intensity Group
pravastatin 40mg daily for 12 weeks
Drug: Pravastatin
40mg daily (Weeks 2 - 14)

Experimental: High Intensity Group
rosuvastatin 20 - 40 mg daily for 12 weeks
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
Other Name: CRESTOR




Primary Outcome Measures :
  1. Mean percent change in fasting LDL-cholesterol [ Time Frame: Week 2 and Week 14 ]
    Mean percent change in fasting LDL-cholesterol at Week 2 and Week 14

  2. Treatment-emergent adverse events [ Time Frame: 14 weeks ]
    Number of Grade 3 or above adverse events


Secondary Outcome Measures :
  1. Mean percent change in fasting HDL-cholesterol [ Time Frame: Week 2 and Week 14 ]
    Mean percent change in fasting HDL-cholesterol at Week 2 and Week 14

  2. Mean percent change in fasting Total Cholesterol [ Time Frame: Week 2 and Week 14 ]
    Mean percent change in fasting Total Cholesterol at Week 2 and Week 14

  3. Mean percent change in fasting Triglycerides [ Time Frame: Week 2 and Week 14 ]
    Mean percent change in fasting Triglycerides at Week 2 and Week 14



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841774


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Matthew Feinstein
Investigators
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Study Chair: Donald Lloyd-Jones, MD Northwestern University
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Responsible Party: Matthew Feinstein, Assistant Professor of Medicine and Preventive Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT02841774    
Other Study ID Numbers: CSC01
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Acute Coronary Syndrome
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Rosuvastatin Calcium
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors