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NCT01148004 · ClinicalTrials.gov registry record · Phase 1
The Influence of Ritonavir, Alone and in Combination With Lopinavir, on Fenofibric Acid Pharmacokinetics in Healthy Volunteers
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT01148004 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 25 participants.
The verdict
NCT01148004, a Phase 1 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
Background: \- Patients infected with the human immunodeficiency virus (HIV) are often treated with protease inhibitors that help fight HIV infection. However, these medications often increase blood cholesterol levels, particularly triglycerides and low-density lipoproteins, and can lead to heart disease and other problems. Patients may take drugs known as fibrates (such as gemfibrozil (Lopid )) to lower triglyceride levels, but even with maximum approved doses patients often cannot reach goal triglyceride levels. Research suggests that fibrates and certain HIV medications, such as ritonavir and lopinavir/ritonavir, may interact and decrease the effectiveness of the fibrate treatment. More research is needed to determine the best drug to lower triglyceride levels in HIV patients who are receiving protease inhibitor therapy. Objectives: \- To evaluate the drug-drug interaction between fenofibrate and protease inhibitors lopinavir/ritonavir and ritonavir. Eligibility: \- Healthy individuals between 18 and 60 years of age. Design: * This study will require a screening visit and 18 study visits. The screening visit will take 3 to 4 hours, and can occur 7 to 30 days before starting the study. The rest of the study, not including the screening visit, is 48 days. Three of the visits will take about 12 hours, and the remaining 15 visits will take about 1 hour. * For study days 1 to 7, participants will take fenofibrate alone. Participants will keep a daily record of medication doses and any side effects. * For study days 8 to 27, participants will take fenofibrate and ritonavir. Participants will keep a daily record of medication doses and any side effects. * For study days 29 to 48, participants will take fenofibrate and lopinavir/ritonavir. Participants will keep a daily record of medication doses and any side effects. * Participants will have regular study visits to provide blood samples for research and monitoring.
Interventions
- DRUG Fenofibrate
- DRUG Ritonavir
- DRUG Lopinavir/Ritonavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-05-13 |
| Est. Completion | 2013-07-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01148004
The ClinicalTrials.gov registry entry for NCT01148004 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Fenofibrate is the first listed.
NCT01148004 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01148004 about?
NCT01148004 is a clinical study titled "The Influence of Ritonavir, Alone and in Combination With Lopinavir, on Fenofibric Acid Pharmacokinetics in Healthy Volunteers". Background: \- Patients infected with the human immunodeficiency virus (HIV) are often treated with protease inhibitors that help fight HIV infection. However, these medications often increase blood cholesterol levels, particularly triglycerides and low-density lipoproteins, and can lead to heart d...
What is the current status of trial NCT01148004?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2010-05-13. Estimated completion is 2013-07-29.
What interventions are being tested in trial NCT01148004?
The interventions under investigation include: Fenofibrate (DRUG), Ritonavir (DRUG), Lopinavir/Ritonavir (DRUG).
Who is sponsoring clinical trial NCT01148004?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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