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The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART) Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART) conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART) Clinical research trials and The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART) health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART). The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART) Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART) clinical trial. Human subjects often get the best healthcare available for their The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART) condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART)  The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART)
The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART)
For Condition: Hypertriglyceridemia,HIV Infections
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to determine the effectiveness of fish oil supplements combined with the drug fenofibrate in treating elevated triglyceride levels in people taking anti-HIV drugs. The participants in this study will have shown no response to fish oil supplements or fenofibrate alone.
Details: Although highly active antiretroviral therapy (HAART) has decreased the morbidity and mortality caused by HIV infection, its use has been associated with lipid abnormalities, particularly elevations in serum triglycerides. Hypertriglyceridemia is a risk factor in the development of cardiovascular and cerebrovascular disease as well as pancreatitis. Lipid-lowering drugs called fibrates have been part of the recommended treatment for elevated triglycerides, but the response to fibrates is incomplete in a large proportion of people. Fish oil capsules containing large amounts of omega-3 fatty acids have been shown to decrease serum triglycerides. However, fish oil supplements or fibrates alone are often inadequate for treating hypertriglyceridemia in people taking HAART. This study will determine whether the combination of the two therapies will lower serum triglycerides in people on HAART more effectively than either therapy alone. This study comprises two steps. In Step I, participants will be randomly assigned to receive either fish oil supplements or fenofibrate. Participants will be evaluated for treatment response at Week 8. Those who have responded to their treatment will remain on their original single agent therapy through Week 18. Those who have not responded to treatment at Week 10 will move on to Step 2 and begin combination therapy with both fenofibrate and fish oil until Week 18. All participants will return at Week 22 for a follow-up visit. Except at the Week 10 visit, participants will be expected to fast prior to all study visits. Participants will remain on their individual HAART regimens for the duration of the study.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - HIV infected - Fasting LDL <= 160 mg/dL and fasting serum triglycerides >= 400 mg/dL within 28 days prior to study entry - Willing and able to adhere to a lipid-lowering diet and exercise program for at least 28 days prior to study start and for the duration of the study - Treatment with HAART for at least 3 months prior to study entry. Participants must be on stable HAART for at least 4 weeks immediately prior to study entry. Participants who have changed from a protease inhibitor (PI)-based regimen to a non-PI-based regimen in the previous 3 months must be on stable HAART for at least 8 weeks immediately prior to study entry. - Willingness to remain on current HAART regimen for the duration of the study - Women of reproductive potential must use an acceptable method of contraception while receiving study drugs and for at least 4 weeks after stopping the study drugs - Men on testosterone replacement therapy must have been on stable therapy for at least 3 months prior to study entry and must be willing to continue stable therapy for the duration of the study - Participants on hormone replacement therapy other than testosterone replacement therapy and participants using oral contraceptives must have been on stable therapy for at least 28 days prior to study entry and must be willing to continue stable therapy for the duration of the study Exclusion Criteria: - Use of investigational antiretroviral drugs within 28 days prior to study entry. Investigational therapies allowed by the study chairs or given in an AACTG study or expanded access trial are permitted, as long as the treatment can be continued for the duration of this study. - Coronary heart disease - Atherosclerotic disease risk - Congestive heart failure - Uncontrolled hypertension within 28 days prior to study entry - Active bleeding disorder or active peptic ulcer disease - Diabetes mellitus that requires pharmacological, dietary control, or diabetic medication within 28 days prior to study entry - Untreated hypothyroidism. Participants who are currently being treated for hypothyroidism are not excluded if the treatment was initiated at least 28 days prior to study entry. - Use of levothyroxine or liothyronine, except for treatment of hypothyroidism, within 90 days prior to study entry. - Active or symptomatic gallbladder disease within 1 year prior to study entry - Use of systemic cancer chemotherapy within 60 days prior to study entry - Cancer within 5 years prior to study entry. Skin cancers not requiring systemic treatment are allowed. - Pregnancy or breast-feeding - Use of any lipid-lowering agent within 28 days prior to study entry - Use of hormonal anabolic therapies within 6 months prior to study entry - Use of systemic steroids - Use of immune modulators within 28 days prior to study entry - Use of anticoagulants within 14 days prior to study entry - Allergy or sensitivity to study drugs or their formulations - Active drug or alcohol use or dependence that would interfere with adherence to study requirements - Decreased mental capacity that would interfere with adherence to study requirements - Active AIDS-defining opportunistic infection (OI) within 28 days prior to study entry. Participants who have no evidence of active disease and are receiving maintenance therapy for AIDS-related OIs will be eligible. - Any acute illness within 28 days prior to study entry that would interfere with participation in the study
Total Enrollment: 100
Location and Contact Information:
Overall Study Official:
JohnGerber, Study Chair, University of Colorado Health Science Center
University of Minnesota
Minneapolis, Minnesota, 55455-0392
United States
Christine Fietzer 612-625-1462
Community Health Network, Inc
Rochester, New York, 14642-0001
United States
Carol Greisberger 585-275-2740
UCLA School of Medicine
Los Angeles, California, 90095-1793
United States
Susan McCarthy 310-206-8029
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1201
United States
Julie Katseres 319-353-8441
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202-5250
United States
Beth Zwickl 317-274-8456
Cleveland Clinic
Cleveland, Ohio, 44106
United States
Ronald Johnson 216-844-3246
San Mateo County AIDS Program
Stanford, California, 94305-5107
United States
Debbie Slamowitz 650-723-2804
Emory University
Atlanta, Georgia, 30308
United States
Ericka Patrick 404-616-6313
University of Rochester Medical Center
Rochester, New York, 14642-0001
United States
Carol Greisberger 585-275-2740
Stanford University
Stanford, California, 94305-5107
United States
Debbie Slamowitz 650-723-2804
The Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401-1004
United States
Lisa Dasnoit 336-832-8062
University of Hawaii
Honolulu, Hawaii, 96816-2396
United States
Debra Ogata-Arkaki 808-737-2751
Comprehensive Care Clinic
Nashville, Tennessee, 37203
United States
Janet Nicotera 615-467-0154
San Francisco General Hospital
San Francisco, California, 94110
United States
Michele Downing 415-514-0550
Beth Israel Medical Center
New York City, New York, 10003
United States
Ann Marshak 212-420-4432
University of North Carolina
Chapel Hill, North Carolina, 27514
United States
Cheryl Marcus 919-843-8761
Willow Clinic
Stanford, California, 94305-5107
United States
Debbie Slamowitz 650-723-2804
University of Washington (Seattle)
Seattle, Washington, 98104
United States
Jeanne Conley 206-731-8877
Washington University (St. Louis)
St. Louis, Missouri, 63108-2138
United States
Michael Klebert 314-454-0058
University of Cincinnati
Cincinnati, Ohio, 45267-0405
United States
Tammy Powell 513-584-8373
Additional Information:
Study ID Numbers: ACTG A5186;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076518
Other Hypertriglyceridemia Studies:
1. Re-evaluating Triglycerides in Coronary Heart Disease
2. Niacin for Treatment of Elevated Cholesterol and Triglycerides in HIV-Infected Patients
3. Garlic in hyperlipidemia caused by HAART
4. The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART)
5. Regulation of Sterol Homeostasis
Related Studies:
Other Hypertriglyceridemia Clinical Trials
Other California Clinical Trials
Other Stanford Clinical Trials
The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART)
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