Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood Lipids
- Conditions
- HIV InfectionsLipodystrophy
- Registration Number
- NCT00006412
- Brief Summary
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.
- Detailed Description
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. \[AS PER AMENDMENT 12/13/01: On June 26, 2001, the DSMB reviewed interim results and determined that the response rates for both arms met the stopping rule for futility. As a result, all patients who were currently on single-agent therapy were offered the opportunity to initiate dual-agent therapy regardless of time on study. No additional accrual was sought; however, exceptions were made for patients who were in screening at the time of the DSMB review. These patients were given the option of starting single- or dual-agent therapy. The DSMB recommended that all patients on dual-agent therapy be followed for 32 weeks to obtain additional safety and efficacy data. Further endpoints will be analyzed after Week 12 of single-agent therapy or Week 32 of dual-agent therapy.\]
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 630
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (58)
Philadelphia Veterans Administration Med Ctr
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hosp
🇺🇸Boston, Massachusetts, United States
Univ of California, San Diego
🇺🇸San Diego, California, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Methodist Hosp of Indiana / Life Care Clinic
🇺🇸Indianapolis, Indiana, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Carolinas Med Ctr
🇺🇸Charlotte, North Carolina, United States
Harbor UCLA Med Ctr
🇺🇸Torrance, California, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
San Mateo AIDS Program / Stanford Univ
🇺🇸Stanford, California, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Emory Univ
🇺🇸Atlanta, Georgia, United States
Willow Clinic
🇺🇸Menlo Park, California, United States
Tripler Army Med Ctr
🇺🇸Tripler AMC, Hawaii, United States
Univ of Hawaii
🇺🇸Honolulu, Hawaii, United States
The CORE Ctr
🇺🇸Chicago, Illinois, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Miriam Hosp / Brown Univ
🇺🇸Providence, Rhode Island, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
Wishard Hosp
🇺🇸Indianapolis, Indiana, United States
Univ of Nebraska Med Ctr
🇺🇸Omaha, Nebraska, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Moses H Cone Memorial Hosp
🇺🇸Greensboro, North Carolina, United States
Brown Univ / Miriam Hosp
🇺🇸Providence, Rhode Island, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Community Health Network Inc
🇺🇸Rochester, New York, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Denver Dept of Health and Hosps
🇺🇸Denver, Colorado, United States
Cornell Clinical Trials Unit - Chelsea Clinic
🇺🇸New York, New York, United States
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Univ of California San Francisco
🇺🇸San Francisco, California, United States
Stanford Univ Med Ctr
🇺🇸Stanford, California, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Beth Israel Deaconess - West Campus
🇺🇸Boston, Massachusetts, United States
Cornell Univ Med Ctr
🇺🇸New York, New York, United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
🇺🇸Rochester, New York, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Univ of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Ohio State Univ Hosp Clinic
🇺🇸Columbus, Ohio, United States
MetroHealth Med Ctr
🇺🇸Cleveland, Ohio, United States
Vanderbilt Univ Med Ctr
🇺🇸Nashville, Tennessee, United States
Rhode Island Hosp / Brown Univ
🇺🇸Providence, Rhode Island, United States
Univ of Texas, Southwestern Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Univ of Texas Galveston
🇺🇸Galveston, Texas, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Univ of Puerto Rico
🇵🇷San Juan, Puerto Rico