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Pharmacokinetic Evaluation of Changes in Nevirapine AUC Due to Differences in Weight

NCT01335360 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2011-04-14

No results posted yet for this 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.

Conditions

  • HIV Infection

Interventions

DRUG

Nevirapine

200mg twice daily of nevirapine

Sponsors & Collaborators

  • Jeffrey Goodman Clinic, LA Gay & Lesbian Center

    collaborator UNKNOWN

  • Western University of Health Sciences

    lead OTHER

Principal Investigators

  • James D Scott, PharmD · Western University of Health Sciences

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2003-05-31
Completion
2003-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01335360 on ClinicalTrials.gov