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

NCT02841774 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-10-18

Study results available
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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

Interventions

DRUG

Pravastatin

40mg daily (Weeks 2 - 14)

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

Sponsors & Collaborators

  • Matthew Feinstein

    lead OTHER

Principal Investigators

  • Donald Lloyd-Jones, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2021-06-30
Completion
2021-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02841774 on ClinicalTrials.gov