Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Pharmacokinetic Evaluation of Changes in Nevirapine AUC Due to Differences in Weight (NAWS)

This study has been completed.
Sponsor:
Collaborator:
Jeffrey Goodman Clinic, LA Gay & Lesbian Center
Information provided by:
Western University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01335360
First received: December 7, 2010
Last updated: April 12, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention
HIV Infection
 Drug: Nevirapine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Pharmacokinetic Evaluation of Changes in Nevirapine AUC Due to Differences in Weight

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Western University of Health Sciences:

Primary Outcome Measures:
  • Differences in AUC based on weight/BMI [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    This study was a "snapshot" of the PK levels following ingestion, and then compared AUC to weight and BMI.


Biospecimen Retention:   None Retained

Levels were drawn prior to dosing, and at the following time intervals: 0.5hr, 1hr, 1.5hr, 2hr, 4hr, 6hr, 8hr, 12hr. ~10cc of blood were drawn with each sample, centrifuged, and plasma separated into 2 cryovials. Samples were then frozen at -20oC. All samples (216) weresent to Consolidated Laboratory Services for level determination by appropriate means. All samples have now been destroyed.
Enrollment: 21
Study Start Date: May 2003
Study Completion Date: June 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects >80kg
As above
 Drug: Nevirapine
200mg twice daily of nevirapine
Subjects <70kg
As above
 Drug: Nevirapine
200mg twice daily of nevirapine
Subjects 70-80kg
As above
 Drug: Nevirapine
200mg twice daily of nevirapine

  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

HIV positive patients stable on a nevirapine containing regimen for at least 3 months

Criteria

Inclusion criteria:

  1. Documented HIV infection
  2. 18-50yrs of age
  3. Male
  4. Currently on nevirapine therapy for at least 3 months
  5. LFT's < 2 times normal limits within one month prior to study date
  6. In good health as judged by their primary care provider or a study provider within one month of the study date
  7. Willing to abstain for 1 week prior to study date
  8. No active opportunistic infections within one month prior to the study date
  9. Willingness to sign informed consent

Exclusion criteria:

  1. Active substance abuse
  2. Poor self reported adherence to nevirapine therapy
  3. Chronic liver disease or active hepatitis
  4. Concurrent administration of medications with a known or suspected pharmacokinetic drug interaction with nevirapine (such as …)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335360

Locations
United States, California
Jeffrey Goodman Clinic
Los Angeles, California, United States, 90028
Sponsors and Collaborators
Western University of Health Sciences
Jeffrey Goodman Clinic, LA Gay & Lesbian Center
Investigators
Principal Investigator: James D Scott, PharmD Western University of Health Sciences
  More Information

No publications provided

Responsible Party: James D. Scott, PharmD, Associate Professor, Western University
ClinicalTrials.gov Identifier: NCT01335360     History of Changes
Other Study ID Numbers: WesternU
Study First Received: December 7, 2010
Last Updated: April 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Western University of Health Sciences:
nevirapine
pharmacokinetics

Additional relevant MeSH terms:
Nevirapine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015