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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID: NCT00099684
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 44
Starts: 2005-11-01
Expected to finish: 2007-05-01
Last updated by the study team: 2012-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
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

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States
UCLA School of Medicine — Los Angeles, California, United States
University of Southern California — Los Angeles, California, United States
University of California, San Diego Antiviral Research Center — San Diego, California, United States
San Francisco General Hospital — San Francisco, California, United States
San Mateo County AIDS Program — Stanford, California, United States
Santa Clara Valley Medical Center — Stanford, California, United States
Stanford University — Stanford, California, United States
Willow Clinic — Stanford, California, United States
Georgetown University Medical Center — Washington D.C., District of Columbia, United States
University of Miami — Miami, Florida, United States
University of Hawaii — Honolulu, Hawaii, United States
Rush-Presbyterian/St. Lukes (Chicago) — Chicago, Illinois, United States
Cook County Hospital Core Center — Chicago, Illinois, United States
Feinberg School of Medicine, HIV/ACTU — Chicago, 60611-3015, Illinois, United States
Indiana University Hospital — Indianapolis, Indiana, United States
Wishard Hospital — Indianapolis, Indiana, United States
University of Minnesota — Minneapolis, Minnesota, United States
Nebraska Health System — Omaha, Nebraska, United States
SUNY - Buffalo (Rochester) — Buffalo, New York, United States
Beth Israel Medical Center — New York, New York, United States
Chelsea Clinic — New York, New York, United States
NYU/Bellevue — New York, New York, United States
The Cornell Clinical Trials Unit — New York, New York, United States
Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

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