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NCT01335360 · ClinicalTrials.gov registry record
Pharmacokinetic Evaluation of Changes in Nevirapine AUC Due to Differences in Weight
A clinical trial, sponsored by Western University of Health Sciences.
- Completed
- Registry status
- 21
- Enrollment target
NCT01335360: Completed study, sponsored by Western University of Health Sciences.
NCT01335360 is a clinical trial that has completed, run by Western University of Health Sciences. The registered enrollment target is 21 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01335360 has completed, sponsored by Western University of Health Sciences.
- COMPLETED
- Registry status
- 21 participants
- Enrollment target
Study Summary
This study would be a prospective cohort study, stratified by weight. Patients who are stable on nevirapine for at least 3 months prior to study entry, but no more than 1year will be recruited. For 1 week, subjects will take their morning dose of nevirapine in the clinic (and be observed taking it), and given their evening dose to take at home. Subjects will need to record the date and time they take their evening dose. At the end of the week, the subjects will be sequestered at the clinic for blood draws for a 12hr pharmacokinetic sampling. They will not be brought back in at 24hrs as they will need to be redosed after 12hrs. They will have Liver Function Tests (LFT's) and other labs drawn at study entry, and one month after the end of study. Pharmacokinetic levels will be analyzed using standard mathematical models, and Area Under the Curve (AUC), Maximum concentration (Cmax), and Minimum Concentration (Cmin) will be compared between groups.
Primary Outcome
This study was a "snapshot" of the PK levels following ingestion, and then compared AUC to weight and BMI.
Interventions
- DRUG Nevirapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2003-05 |
| Est. Completion | 2003-06 |
What the finished NCT01335360 record still lists
NCT01335360 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 21 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Nevirapine is the first listed.
NCT01335360 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01335360 about?
NCT01335360 is a clinical study titled "Pharmacokinetic Evaluation of Changes in Nevirapine AUC Due to Differences in Weight". This study would be a prospective cohort study, stratified by weight. Patients who are stable on nevirapine for at least 3 months prior to study entry, but no more than 1year will be recruited. For 1 week, subjects will take their morning dose of nevirapine in the clinic (and be observed taking it),...
What is the current status of trial NCT01335360?
This trial is currently completed. The enrollment target is 21 participants. The study started on 2003-05. Estimated completion is 2003-06.
What interventions are being tested in trial NCT01335360?
The interventions under investigation include: Nevirapine (DRUG).
Who is sponsoring clinical trial NCT01335360?
This trial is sponsored by Western University of Health Sciences, which has 16 total clinical trials registered on ClinicalTrials.gov.
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