Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood Lipids
Status:
Completed
Trial end date:
2003-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)