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Ensayos clínicos

Ensayos clínicos

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

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00099684, ACTG A5209
  • Concluido

Propósito del estudio

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.

Afección:
Infecciones por el VIH

Detalles del estudio

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).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).

Criterios de inclusión

    • 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

Criterios de exclusión

    :
    • 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

Centros de estudio/contactos

Alabama

    University of Alabama at Birmingham, Birmingham, Alabama, 35924-2050, United States

California

    University of Southern California, Los Angeles, California, 90033-1079, United States

    UCLA School of Medicine, Los Angeles, California, 77555-0435, 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

    Santa Clara Valley Medical Center, Stanford, California, 94305-5107, United States

    San Mateo County AIDS Program, Stanford, California, 94305-5107, United States

    Stanford University, Stanford, California, 94305-5107, United States

    Willow Clinic, Stanford, California, 94305-5107, United States

District of Columbia

    Georgetown University Medical Center, Washington, District of Columbia, 20007, United States

Florida

    University of Miami, Miami, Florida, 33136-1013, United States

Hawaii

    University of Hawaii, Honolulu, Hawaii, 96816-2396, United States

Illinois

    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

    Indiana University Hospital, Indianapolis, Indiana, 46202-5250, United States

    Wishard Hospital, Indianapolis, Indiana, 46202, United States

Minnesota

    University of Minnesota, Minneapolis, Minnesota, 55455-0392, United States

Nebraska

    Nebraska Health System, Omaha, Nebraska, 68198-5130, United States

New York

    SUNY - Buffalo (Rochester), Buffalo, New York, 14215, United States

    The Cornell Clinical Trials Unit, New York, New York, 10021, United States

    Beth Israel Medical Center, New York, New York, 10003, United States

    NYU/Bellevue, New York, New York, 10016-6481, United States

    Chelsea Clinic, New York, New York, 10011, United States

    Columbia University, New York, New York, 10032-3784, United States

    University of Rochester Medical Center, Rochester, New York, 14642-0001, United States

    Community Health Network, Inc., Rochester, New York, 14642-0001, United States

North Carolina

    Duke University Medical Center, Durham, North Carolina, 14642-0001, United States

Ohio

    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

Pennsylvania

    University of Pennsylvania, Philadelphia, Philadelphia, Pennsylvania, 19104, United States

    Presbyterian Medical Center - Univ. of PA, Philadelphia, Pennsylvania, 19104, United States

    University of Pittsburgh, Pittsburgh, Pennsylvania, 15213-2582, United States

Rhode Island

    The Miriam Hospital, Providence, Rhode Island, 02906, United States

    Rhode Island Hospital, Providence, Rhode Island, 02906, United States

    Stanley Street Treatment and Resource, Providence, Rhode Island, 02906, United States

Tennessee

    Comprehensive Care Clinic, Nashville, Tennessee, 37203, United States

Texas

    Dallas VA Medical Center, Dallas, Texas, 75235-9173, United States

    University of Texas, Galveston, Galveston, Texas, 77555-0435, United States

Washington

    University of Washington (Seattle), Seattle, Washington, 98104, United States

    University of Puerto Rico, San Juan, Washington, 00936-5067, Puerto Rico

Actualizado: 15 de abril del 2005

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