Pharmacokinetic Evaluation of Changes in Nevirapine AUC Due to Differences in Weight
Public ClinicalTrials.gov record NCT01335360. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01335360
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 21 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2003
- Primary completion
- Apr 30, 2003
- Completion
- May 31, 2003
- Last update posted
- Apr 13, 2011
2003
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Jeffrey Goodman Clinic | Los Angeles | California | 90028 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01335360, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 13, 2011 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01335360 live on ClinicalTrials.gov.