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: Body Weight HIV/AIDS

Drug Information available for: Nevirapine

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 (Adult)
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:

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

Exclusion criteria:

Active substance abuse
Poor self reported adherence to nevirapine therapy
Chronic liver disease or active hepatitis
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


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:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Nevirapine	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

ClinicalTrials.gov processed this record on September 30, 2016

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