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

NCT02841774 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CSC01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV Infection; Coronary Heart Disease

Outcome Measures

Primary Outcomes (2)

• 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

• Treatment-emergent Adverse Events

  Number of Grade 3 or above adverse events

  14 weeks

Study Arms (2)

Moderate Intensity Group

ACTIVE COMPARATOR

pravastatin 40mg daily for 12 weeks

Drug: Pravastatin

High Intensity Group

EXPERIMENTAL

rosuvastatin 20 - 40 mg daily for 12 weeks

Drug: Rosuvastatin

Interventions

Pravastatin DRUG

40mg daily (Weeks 2 - 14)

Moderate Intensity Group

Rosuvastatin 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

Also known as: CRESTOR

High Intensity Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 infection
• HIV RNA below the lower limit of assay detection within 12 months of study entry
• \) 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Matthew Feinstein: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

HIV Infections; Coronary Disease

Interventions

Pravastatin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Matthew Feinstein
• Organization: Northwestern University

matthewjfeinstein@northwestern.edu

3126643278

Study Officials

• Donald Lloyd-Jones, MD

  Northwestern University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine and Preventive Medicine

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 22, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 18, 2022
• Results First Posted: October 18, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)