Status:
COMPLETED
Safety, Effectiveness, and Tolerability of Ezetimibe Combined With Statins for the Treatment of High Cholesterol in HIV Infected Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
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 chole...
Detailed Description
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 bo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00099684
Start Date
November 1 2005
End Date
May 1 2007
Last Update
October 29 2012
Active Locations (42)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35924-2050
2
UCLA School of Medicine
Los Angeles, California, United States, 77555-0435
3
University of Southern California
Los Angeles, California, United States, 90033-1079
4
University of California, San Diego Antiviral Research Center
San Diego, California, United States, 92103