|
Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids Clinical research trials and Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids. Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids clinical trial. Participants frequently get the best healthcare available for their Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids  Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids
Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids
For Condition: HIV Infections,Lipodystrophy
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to compare the safety and effectiveness of fenofibrate and pravastatin in treating HIV-positive patients who have abnormal levels of fat (lipids) in the blood. Increased lipids in the blood associated with HIV infection and anti-HIV drugs is a growing problem. The drugs used in this study are known to reduce certain lipids, but little is known about their safety and effectiveness. This study will see if one of the drugs is safer and more effective than the other, or if combining the drugs is the safest and most effective way to lower lipids. This study has been changed. On June 26, 2001, this study was reviewed by the Data and Safety Monitoring Board (DSMB). The DSMB is an independent board monitoring the progress of the study. The review showed that neither pravastatin nor fenofibrate alone were effective in reaching all the cholesterol and triglyceride goals. There were no safety concerns. It is not known if the combination of fenofibrate and pravastatin is effective and safe. Therefore, it is important to continue this study.
Details: Lipid disorders associated with HIV infection and antiretroviral therapy are of growing concern. There is little information available on the safety and efficacy of statins or fibrates in the treatment of HIV-associated hyperlipidemias. Fenofibrate and pravastatin both are able to reduce low-density lipoproteins (LDL) and triglycerides (TG), but it is unclear whether one therapy will be more effective than the other, or if combination therapy will be needed to achieve desirable reductions in both LDL and TG. [AS PER AMENDMENT 12/13/01: The NIAID HIV Therapeutic Trials Data and Safety Monitoring Board (DSMB) met June 26, 2001 to review the interim results. The interim monitoring plan for this study states that accrual into either single-agent therapy arm should stop if the response rate failed to meet a pre-specified minimum at the time of interim review. The DSMB found that this stopping criterion was met for each single-therapy arm. The DSMB recommended that patients currently on single-agent therapy be offered the opportunity to initiate dual-agent therapy, regardless of time on study. There were no safety concerns.] Patients are randomized to either Arm A or Arm B and stratified by gender, TG level, and number of cardiovascular risk factors. Patients add daily fenofibrate (Arm A) or pravastatin (Arm B) to their antiretroviral therapy for 48 weeks. Evaluations at Week 12 determine LDL, TG, and high-density lipid (HDL) levels. Patients who achieve clinical goals for these levels stay on the drug for the rest of the study. Patients who do not achieve the goals by Week 12 receive a combination of pravastatin and fenofibrate for the rest of the study. At regular clinic visits, patients have physical exams and are questioned about their medications, diet, and exercise. Blood samples are drawn for clinical evaluations, including lipid profiles and HIV-1 RNA monitoring. [AS PER AMENDMENT 12/13/01: On June 26, 2001, the DSMB reviewed interim results and determined that the response rates for both arms met the stopping rule for futility. As a result, all patients who were currently on single-agent therapy were offered the opportunity to initiate dual-agent therapy regardless of time on study. No additional accrual was sought; however, exceptions were made for patients who were in screening at the time of the DSMB review. These patients were given the option of starting single- or dual-agent therapy. The DSMB recommended that all patients on dual-agent therapy be followed for 32 weeks to obtain additional safety and efficacy data. Further endpoints will be analyzed after Week 12 of single-agent therapy or Week 32 of dual-agent therapy.]
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Are at least 18 years old. - Are on a lipid-lowering diet based on the patient's statement and have been exercising for at least 30 days before being screened for the study. Patients will be asked if they were counseled by their health care provider. The lipid-lowering diet and exercise program do not have to be prescribed by a physician. - Have a triglyceride (TG) level of at least 200 mg/dl and low-density lipoprotein (LDL) level of at least 130 mg/dl after fasting for 8 to 12 hours. - Have been treated with anti-HIV drugs for more than 6 months. Patients must be taking the anti-HIV drugs regularly for at least 4 weeks before they enter the study. Patients must be taking anti-HIV drugs regularly for at least 8 weeks if they have changed from taking protease inhibitor (PI) anti-HIV drugs to non-PI anti-HIV drugs. Any combination without a PI must lower the patient's HIV viral levels, as determined by the patient's physician. - Are willing, if able to become pregnant, to use 2 reliable types of birth control while taking the study drug(s) and for 1 month after stopping the drug(s). - Have a negative pregnancy test. - (This reflects a change in inclusion requirements.) Exclusion Criteria Patients will not be eligible for the study if they: - Have a history of heart disease. - Have uncontrolled high blood pressure within 4 weeks of study entry. - Have liver disease. - Have gall bladder disease or symptoms within 3 months prior to study entry or symptoms of gallstones. - Had surgery to remove their gallbladder within 3 months prior to study entry. - Have diabetes requiring drug treatment or diabetes not controlled by diet. - Have hypothyroidism (low thyroid activity). - Are allergic or sensitive to the study drug(s) or to other lipid-lowering drugs. - Have rhabdomyolysis (a muscle disease). - Have taken any prescription or non-prescription lipid-lowering drug within 14 days prior to study entry or for over 24 weeks in the past. - Take prescription lipid-lowering agents, other than those given by the study, and non-prescription lipid-lowering agents such as garlic supplements. - Have failed previous statin or fibrate therapy (after 24 weeks of treatment) or have had side effects from these drugs. - Receive or have received (within 14 days of study entry) treatment not approved by the FDA. Anti-HIV medications and immune-based treatments not approved by the FDA may be allowed on a case-by-case basis with the approval of the protocol team. - Were given systemic chemotherapy for cancer other than Kaposi's sarcoma (KS). - Were given radiation therapy within 30 days of study entry. - Take drugs that increase risk of muscle disease (such as cyclosporine, erythromycin, itraconazole, and ketoconazole), within 14 days of study entry. - Take or have taken levothyroxine and liothyronine for hypothyroidism. - Take high doses of testosterone. - Take creatine monophosphate or drugs that affect the immune system, within 30 days of study entry. - Abuse drugs or alcohol, and the doctor thinks this may interfere with the study. - Are pregnant or breast-feeding. - Had a scheduled anti-HIV treatment withdrawal prior to study entry. - (This reflects a change in exclusion requirements.)
Total Enrollment: 630
Location and Contact Information:
Overall Study Official:
JudithAberg, Study Chair,
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Washington
Seattle, Washington, 98104
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Univ of California San Francisco
San Francisco, California, 94110
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, 14642
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Tripler Army Med Ctr
Tripler AMC, Hawaii, 96859
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
University of California San Francisco
San Francisco, California, 941104206
United States
Community Health Network Inc
Rochester, New York, 14642
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Denver Dept of Health and Hosps
Denver, Colorado, 80262
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02215
United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390
United States
Cornell Clinical Trials Unit - Chelsea Clinic
New York City, New York, 10011
United States
Emory Univ
Atlanta, Georgia, 30308
United States
Univ of California, San Diego
San Diego, California, 92103
United States
The CORE Ctr
Chicago, Illinois, 60612
United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Wishard Hosp
Indianapolis, Indiana, 46202
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Rhode Island Hosp / Brown Univ
Providence, Rhode Island, 02903
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Willow Clinic
Menlo Park, California, 94025
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Additional Information:
Study ID Numbers: ACTG A5087; AACTG A5087
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006412
Other Lipodystrophy Studies:
1. A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
2. Leptin to Treat Lipodystrophy
3. Metabolism and Body Shape of Healthy Children and Children with Chronic Infections
4. Changing to Nonprotease Inhibitor Treatment to Improve Side Effects
5. Underlying abnormalities in fat and muscle leading to Lipodystrophy Syndrome
Related Studies:
Other Lipodystrophy Clinical Trials
Other Indiana Clinical Trials
Other Indianapolis Clinical Trials
Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids
|
|
|
|
|
|
|
|
