Safety, Effectiveness, and Tolerability of Ezetimibe Combined With Statins for the Treatment of High Cholesterol in HIV Infected Adults
A Pilot Study of the Safety, Efficacy, and Tolerability of Ezetimibe (Zetia) in Combination With Statin Therapy for the Treatment of Elevated LDL Cholesterol in HIV-Infected Subjects
1 other identifier
interventional
44
2 countries
42
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
Started Nov 2005
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2004
CompletedFirst Posted
Study publicly available on registry
December 20, 2004
CompletedStudy Start
First participant enrolled
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedOctober 29, 2012
October 1, 2012
December 17, 2004
October 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in directly measured fasting LDL-c while receiving ezetimibe compared to change while receiving placebo
changes in clinical symptoms and safety labs while receiving ezetimibe compared to changes in clinical symptoms while receiving placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
University of Alabama at Birmingham
Birmingham, Alabama, 35924-2050, United States
UCLA School of Medicine
Los Angeles, California, 77555-0435, United States
University of Southern California
Los Angeles, California, 90033-1079, United States
University of California, San Diego Antiviral Research Center
San Diego, California, 92103, United States
San Francisco General Hospital
San Francisco, California, 94110, United States
San Mateo County AIDS Program
Stanford, California, 94305-5107, United States
Santa Clara Valley Medical Center
Stanford, California, 94305-5107, United States
Stanford University
Stanford, California, 94305-5107, United States
Willow Clinic
Stanford, California, 94305-5107, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
University of Miami
Miami, Florida, 33136-1013, United States
University of Hawaii
Honolulu, Hawaii, 96816-2396, United States
Rush-Presbyterian/St. Lukes (Chicago)
Chicago, Illinois, 60611-3015, United States
Cook County Hospital Core Center
Chicago, Illinois, 60612, United States
Feinberg School of Medicine, HIV/ACTU
Chicago, 60611-3015, Illinois, 60611-3015, United States
Indiana University Hospital
Indianapolis, Indiana, 46202-5250, United States
Wishard Hospital
Indianapolis, Indiana, 46202, United States
University of Minnesota
Minneapolis, Minnesota, 55455-0392, United States
Nebraska Health System
Omaha, Nebraska, 68198-5130, United States
SUNY - Buffalo (Rochester)
Buffalo, New York, 14215, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Chelsea Clinic
New York, New York, 10011, United States
NYU/Bellevue
New York, New York, 10016-6481, United States
The Cornell Clinical Trials Unit
New York, New York, 10021, United States
Columbia University
New York, New York, 10032-3784, United States
Community Health Network, Inc.
Rochester, New York, 14642-0001, United States
University of Rochester Medical Center
Rochester, New York, 14642-0001, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, 45267-0405, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109-1998, United States
Ohio State University
Columbus, Ohio, 43210, United States
Presbyterian Medical Center - Univ. of PA
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213-2582, United States
Rhode Island Hospital
Providence, Rhode Island, 02906, United States
Stanley Street Treatment and Resource
Providence, Rhode Island, 02906, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Comprehensive Care Clinic
Nashville, Tennessee, 37203, United States
Dallas VA Medical Center
Dallas, Texas, 75235-9173, United States
University of Texas, Galveston
Galveston, Texas, 77555-0435, United States
University of Washington (Seattle)
Seattle, Washington, 98104, United States
University of Puerto Rico
San Juan, 00936-5067, Puerto Rico
Related Publications (4)
Calza L, Manfredi R, Chiodo F. Dyslipidaemia associated with antiretroviral therapy in HIV-infected patients. J Antimicrob Chemother. 2004 Jan;53(1):10-4. doi: 10.1093/jac/dkh013. Epub 2003 Nov 25.
PMID: 14645323BACKGROUNDColagreco JP. Cardiovascular considerations in patients treated with HIV protease inhibitors. J Assoc Nurses AIDS Care. 2004 Jan-Feb;15(1):30-41. doi: 10.1177/1055329003256922.
PMID: 14983559BACKGROUNDMartinez E, Tuset M, Milinkovic A, Miro JM, Gatell JM. Management of dyslipidaemia in HIV-infected patients receiving antiretroviral therapy. Antivir Ther. 2004 Oct;9(5):649-63.
PMID: 15535403BACKGROUNDVisnegarwala F, Maldonado M, Sajja P, Minihan JL, Rodriguez-Barradas MC, Ong O, Lahart CJ, Hasan MQ, Balasubramanyam A, White AC Jr. Lipid lowering effects of statins and fibrates in the management of HIV dyslipidemias associated with antiretroviral therapy in HIV clinical practice. J Infect. 2004 Nov;49(4):283-90. doi: 10.1016/j.jinf.2003.09.006.
PMID: 15474625BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Susan Koletar, MD
Division of Infectious Diseases, Ohio State University
- STUDY CHAIR
Dominic Chow, MD, MPH
University of Hawaii, Hawaii AIDS Clinical Research Program, Leahi Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2004
First Posted
December 20, 2004
Study Start
November 1, 2005
Study Completion
May 1, 2007
Last Updated
October 29, 2012
Record last verified: 2012-10