Home
Clinical Trials
NCT00099684

Safety, Effectiveness, and Tolerability of Ezetimibe Combined With Statins for the Treatment of High Cholesterol in HIV Infected Adults

Last Updated: 2012-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Anti-HIV drugs, especially protease inhibitors (PIs), have been linked to lipid metabolism problems, including elevations in low density lipoprotein cholesterol (LDL-c), triglycerides, and total cholesterol. Ezetimibe is a lipid-controlling drug; statins are part of another class of lipid-lowering drugs popularly prescribed to people with high cholesterol. The purpose of this study is to determine the safety, effectiveness, and tolerability of ezetimibe in combination with statin therapy in adults who are taking anti-HIV drugs and have high cholesterol.

Study hypothesis: In HIV infected adults, ezetimibe in combination with statin therapy will result in significantly lower LDL-c compared to statin therapy alone.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Lipid metabolism abnormalities are common complications of HIV therapy, particularly with PIs. Statins and other lipid-lowering agents are often prescribed to control elevated cholesterol levels in both HIV infected and uninfected people. However, both antiretroviral therapy (ART) and lipid-lowering drugs may be associated with cardiovascular disease, so there is a clear need to find a lipid-lowering drug with low toxicity. This study will evaluate the safety, efficacy, and tolerability of ezetimibe, a lipid-controlling agent, in combination with ongoing statin therapy in HIV infected people currently on ART.

This study will last 28 weeks. All participants will be required to continue their current stable statin therapy and ART for the duration of the study.

Participants will be randomly assigned to one of two arms. Arm 1 participants will receive ezetimibe daily for 12 weeks, no treatment for 4 weeks, then placebo daily for 12 weeks. Arm 2 participants will receive placebo daily for 12 weeks, no treatment for 4 weeks, and then ezetimibe daily for 12 weeks. There will be 9 study visits; they will occur at study screening, at study entry, and every 4 weeks thereafter. Clinical assessment and blood collection will occur at all visits. Participants will be asked to complete an adherence questionnaire at Weeks 4, 12, 20, and 28, and will also be encouraged to coenroll in ACTG A5128 (Consent for Use of Stored Patient Specimens for Future Testing).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Treatment Experienced

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ezetimibe

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* HIV infected
* On ART for at least 3 months prior to study entry, and on stable ART for at least 30 days prior to study entry
* Taking one of the study-recommended statins for at least 3 months prior to study entry, and on stable statin therapy for at least 30 days immediately prior to study entry
* On lipid-lowering diet and exercise program for at least 30 days prior to screening, and willing to continue both for the duration of the study
* LDL-c of 130 mg/dL or greater within 30 days prior to study entry
* Willing to use acceptable forms of contraception
* If on hormone replacement therapy, must be on a stable dose or dose-equivalent therapy for at least 30 days prior to study entry, and must be willing to continue the same dose for the duration of the study. People taking physiologic testosterone replacement therapy are not excluded.
* If taking oral contraceptives, must be on a stable dose or dose-equivalent therapy for at least 30 days prior to study entry, and must be willing to continue the same dose for the duration of the study

Exclusion Criteria

* Active cancer or new diagnosis of cancer within the last 5 years. People with skin cancers, including Kaposi's sarcoma, that do not require systemic treatment are not excluded.
* Prior use of ezetimibe
* Known allergy or sensitivity to ezetimibe or its components
* Diabetes mellitus or use of any diabetic medications within 30 days prior to study entry
* History of coronary heart disease
* History of or current congestive heart failure (New York Heart Association Class III or IV)
* Known atherosclerotic disease risk (e.g., history of myocardial infection, bypass surgery, angioplasty, angina pectoris with a positive stress test or angiographic documentation)
* Vascular abnormalities (e.g., cerebrovascular disease, peripheral vascular disease, abdominal aortic aneurysm, or leg artery blockages)
* Untreated or uncontrolled hypothyroidism
* Current drug or alcohol abuse that may interfere with the study
* Testosterone therapy beyond normal physiologic levels of the hormone within 3 months prior to study entry
* Initiation or change in physiologic testosterone replacement therapy within 3 months prior to study entry
* Hormonal anabolic therapies within 3 months prior to study entry
* Systemic cancer chemotherapy or immunomodulators (e.g., growth factors, immune globulin, interleukins, and interferons) within 60 days prior to study entry
* Lipid-lowering agents (except statins) within 30 days prior to study entry
* Any corticosteroid therapy above replacement levels within 30 days prior to study entry
* Untreated or uncontrolled hypertension
* Active AIDS-defining opportunistic infection (OI) within 30 days prior to study entry. People who have no evidence of active disease and are receiving maintenance therapy for AIDS-related OIs are not excluded.
* Acute illness that would interfere with the study within 30 days prior to study entry
* Investigational agents. People using expanded access investigational antiretroviral drugs are not excluded.
* Decreased mental capacity that may interfere with the study
* Pregnant or breastfeeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susan Koletar, MD

Role: STUDY_CHAIR

Division of Infectious Diseases, Ohio State University

Dominic Chow, MD, MPH

Role: STUDY_CHAIR

University of Hawaii, Hawaii AIDS Clinical Research Program, Leahi Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

UCLA School of Medicine

Los Angeles, California, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

University of California, San Diego Antiviral Research Center

San Diego, California, United States

Site Status

San Francisco General Hospital

San Francisco, California, United States

Site Status

San Mateo County AIDS Program

Stanford, California, United States

Site Status

Santa Clara Valley Medical Center

Stanford, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

Willow Clinic

Stanford, California, United States

Site Status

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

University of Hawaii

Honolulu, Hawaii, United States

Site Status

Rush-Presbyterian/St. Lukes (Chicago)

Chicago, Illinois, United States

Site Status

Cook County Hospital Core Center

Chicago, Illinois, United States

Site Status

Feinberg School of Medicine, HIV/ACTU

Chicago, 60611-3015, Illinois, United States

Site Status

Indiana University Hospital

Indianapolis, Indiana, United States

Site Status

Wishard Hospital

Indianapolis, Indiana, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Nebraska Health System

Omaha, Nebraska, United States

Site Status