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

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ClinicalTrials.gov Identifier: NCT01335360
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : April 14, 2011
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
HIV Infection Drug: Nevirapine

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Pharmacokinetic Evaluation of Changes in Nevirapine AUC Due to Differences in Weight
Study Start Date : May 2003
Primary Completion Date : May 2003
Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Nevirapine
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Differences in AUC based on weight/BMI [ Time Frame: 12 hours ]
    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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335360

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
Principal Investigator: James D Scott, PharmD Western University of Health Sciences
More Information

Responsible Party: James D. Scott, PharmD, Associate Professor, Western University
ClinicalTrials.gov Identifier: NCT01335360     History of Changes
Other Study ID Numbers: WesternU
First Posted: April 14, 2011    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: April 2011

Keywords provided by Western University of Health Sciences:

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers