Trial · NCT00474201
Drug Interaction Study of Lopinavir/Ritonavir and Gemfibrozil
NCT00474201, Not applicable, Completed, National Institutes of Health Clinical Center (CC); results first posted 2012-04-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Drug Interaction Study of Lopinavir/Ritonavir and Gemfibrozil. Trials, record NCT00474201. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00474201
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Drug Interaction Study of Lopinavir/Ritonavir and Gemfibrozil
- NCT number
- NCT00474201
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 15 participants, actual
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Conditions
- Healthy Volunteers
- Interventions
- Lopinavir/Ritonavir, Gemfibrozil
- First posted
- 2007-05-16
- Last updated
- 2016-09-26
- Results first posted
- 2012-04-09
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Gemfibrozil Area Under the Concentration vs. Time Curve (AUC) | 22 days per subject (approximately 1 year for entire study completion) | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Gemfibrozil Area Under the Concentration vs. Time Curve (AUC) | 22 days per subject (approximately 1 year for entire study completion) | 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. | ng*hr/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Gemfibrozil Area Under the Concentration vs. Time Curve (AUC) | Gemfibrozil Alone (Control Group) | 104 | 90% Confidence Interval 90 to 118 | ng*hr/mL | |
| Gemfibrozil Area Under the Concentration vs. Time Curve (AUC) | Gemfibrozil + Lopinavir-ritonavir | 62 | 90% Confidence Interval 55 to 68 | ng*hr/mL |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gemfibrozil (GF) Alone Followed by GF+ Lopinavir-ritonavir | 15 | |
| Overall Study | COMPLETED | Gemfibrozil (GF) Alone Followed by GF+ Lopinavir-ritonavir | 15 | |
| Overall Study | NOT COMPLETED | Gemfibrozil (GF) Alone Followed by GF+ Lopinavir-ritonavir | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gemfibrozil (GF) Alone Followed by GF + Lopinavir-ritonavir | ||
| Total, other adverse events | Gemfibrozil (GF) Alone Followed by GF + Lopinavir-ritonavir | 0 | 15 |
| Total, serious adverse events | Gemfibrozil (GF) Alone Followed by GF + Lopinavir-ritonavir | 0 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19648824 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00474201
GET https://conductscience.org/api/trials/v1/NCT00474201/registered