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NCT00474201 · ClinicalTrials.gov registry record · NA
Drug Interaction Study of Lopinavir/Ritonavir and Gemfibrozil
A NA study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT00474201: Completed NA study, sponsored by National Institutes of Health Clinical Center (CC).
NCT00474201 is a NA study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00474201, a NA study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
This study will determine whether the protease inhibitor lopinavir/ ritonavir (Kaletra (Trademark)), which is used to treat HIV disease, lowers blood levels of the lipid-regulating drug gemfibrozil (Lopid (Trademark)) in HIV-negative healthy volunteers. Many patients with HIV infection who take protease inhibitors have abnormally high lipids (cholesterol and triglycerides). Gemfibrozil, commonly used to treat high triglycerides, often is not effective in HIV-infected patients taking protease inhibitors, possibly because of an interaction between the two medicines that causes a lowering of gemfibrozil's levels in the blood. Results from this study will give researchers information on whether lopinavir/ ritonavir affects the blood levels of gemfibrozil. Healthy, normal volunteers between 18 and 65 years old who test negative for HIV may be eligible for this study. On study day 1, subjects have a blood sample drawn from a catheter inserted into a vein in the arm to determine pre-dosing blood levels of gemfibrozil. They then take a gemfibrozil tablet and are given breakfast 30 minutes after taking the drug. Blood samples are obtained through the catheter at 0, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after dosing to determine gemfibrozil levels at those intervals. At the end of 12 hours, the catheter is removed and the subject is discharged from the clinic. The next morning subjects return to the clinic for another blood sample, collected through a vein in the arm. Subjects begin taking lopinavir/ ritonavir between 7 and 35 days after their first dose, depending on their schedule and the clinic schedule. On the fourteenth day of dosing subjects come to the clinic and are given a single dose of gemfibrozil, as on study day 1, and have breakfast 30 minutes later. Blood samples are collected to determine gemfibrozil levels just like on study days 1 and 2. An additional sample is collected for routine lab tests.
Primary Outcome
AUC (ng\*hr/mL) of gemfibrozil when given as a 600 mg dose by itself compared to gemfibrozil AUC after 14.5 days of lopinavir-ritonavir (400mg/100mg) twice daily.
Interventions
- DRUG Lopinavir/Ritonavir
- DRUG Gemfibrozil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2007-05 |
| Est. Completion | 2008-07 |
| Phase | NA |
What the finished NCT00474201 record still lists
NCT00474201 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Lopinavir/Ritonavir is the first listed.
NCT00474201 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00474201 about?
NCT00474201 is a clinical study titled "Drug Interaction Study of Lopinavir/Ritonavir and Gemfibrozil". This study will determine whether the protease inhibitor lopinavir/ ritonavir (Kaletra (Trademark)), which is used to treat HIV disease, lowers blood levels of the lipid-regulating drug gemfibrozil (Lopid (Trademark)) in HIV-negative healthy volunteers. Many patients with HIV infection who take prot...
What is the current status of trial NCT00474201?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2007-05. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00474201?
The interventions under investigation include: Lopinavir/Ritonavir (DRUG), Gemfibrozil (DRUG).
Who is sponsoring clinical trial NCT00474201?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00474201's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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