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

HIV Infection Clinical Trial

— HILLCLIMBER  

Official title:

High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Living With Human Immunodeficiency Virus (HILLCLIMBER)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841774
• Other study ID #: CSC01
• Status: Completed
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: June 2021

Study information

• Verified date: September 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• HIV Infection
• Myocardial Ischemia

Intervention

Drug:
• Pravastatin
40mg daily (Weeks 2 - 14)
• 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

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Matthew Feinstein

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Change in Fasting LDL-cholesterol	Mean percent change in fasting LDL-cholesterol at Week 2 and Week 14	Week 2 and Week 14
Primary	Treatment-emergent Adverse Events	Number of Grade 3 or above adverse events	14 weeks