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NCT00006412 · ClinicalTrials.gov registry record · Phase 3
Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood Lipids
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 630
- Enrollment target
NCT00006412 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 630 participants.
The verdict
NCT00006412, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 630 participants
- Enrollment target
Study 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.
Interventions
- DRUG Fenofibrate
- DRUG Pravastatin sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 630 participants |
| Est. Completion | 2003-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006412
The ClinicalTrials.gov registry entry for NCT00006412 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 630 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fenofibrate is the first listed.
NCT00006412 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00006412 about?
NCT00006412 is a clinical study titled "Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood Lipids". 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...
What is the current status of trial NCT00006412?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 630 participants. Estimated completion is 2003-05.
What interventions are being tested in trial NCT00006412?
The interventions under investigation include: Fenofibrate (DRUG), Pravastatin sodium (DRUG).
Who is sponsoring clinical trial NCT00006412?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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