Drug Interaction Study of Lopinavir/Ritonavir and Gemfibrozil
Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)