Trial Outcomes & Findings for Drug Interaction Study of Lopinavir/Ritonavir and Gemfibrozil (NCT NCT00474201)
NCT ID: NCT00474201
Last Updated: 2016-09-26
Results Overview
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.
COMPLETED
NA
15 participants
22 days per subject (approximately 1 year for entire study completion)
2016-09-26
Participant Flow
Up to 30 healthy volunteers will be screened to enroll a total of 15 healthy volunteers. We will actively encourage participation of all ethnic groups and females. Recruitment of HIV-negative volunteers will be done through the normal volunteer office at NIH.
Subjects who meet inclusion criteria and do not meet any exclusion criteria will be invited to participate in the study.
Participant milestones
| Measure |
Gemfibrozil (GF) Alone Followed by GF+ Lopinavir-ritonavir
Subjects received a single 600 mg dose of gemfibrozil before and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected to determine gemfibrozil plasma concentrations. These plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameter values such as area under the concentration vs. time curve (AUC). Gemfibrozil PK parameter values were then compared before- and after lopinavir-ritonavir administration.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Drug Interaction Study of Lopinavir/Ritonavir and Gemfibrozil
Baseline characteristics by cohort
| Measure |
Gemfibrozil (GF) Alone Followed by GF + Lopinavir-ritonavir
n=15 Participants
Subjects received a single 600 mg dose of gemfibrozil before- and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected for the determination of gemfibrozil plasma concentrations. The plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameters values such as area under the concentration vs. time curve (AUC). PK Parameter values were then compared pre- and post lopinavir-ritonavir administration.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 22 days per subject (approximately 1 year for entire study completion)Population: Fifteen healthy volunteers were enrolled in this protocol based on an a priori power analysis. All 15 subjects completed the protocol and results reported are those from all 15 participants.
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.
Outcome measures
| Measure |
Gemfibrozil Alone (Control Group)
n=15 Participants
Subjects received a single 600 mg dose of gemfibrozil and serial blood samples were collected over a 24 hr. post-dose period to determine pharmacokinetic parameter values. Area under the concentrations vs. time curve from time zero to infinity (i.e. total drug exposure) was the primary pharmacokinetic parameter of interest. After completing participation in this control group, each subject "crossed over" to received lopinavir-ritonavir (400mg/100mg twice daily) for 14.5 days. Therefore, each subject served as their own control. Hence there were two groups of data analyzed, but each group consisted of the same subjects (tested under different conditions).
|
Gemfibrozil + Lopinavir-ritonavir
n=15 Participants
After receiving lopinavir-ritonavir (400mg/100mg twice daily) for 14.5 days, subjects received a single 600 mg dose of gemfibrozil and serial blood samples were collected over a 24 hr. post-dose period to determine pharmacokinetic parameter values. Area under the concentrations vs. time curve from time zero to infinity (i.e. total drug exposure) was the primary pharmacokinetic parameter of interest.
|
|---|---|---|
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Gemfibrozil Area Under the Concentration vs. Time Curve (AUC)
|
104 ng*hr/mL
Interval 90.0 to 118.0
|
62 ng*hr/mL
Interval 55.0 to 68.0
|
Adverse Events
Gemfibrozil (GF) Alone Followed by GF + Lopinavir-ritonavir
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place