Genetic Determinants of the Metabolism of Non-Nucleoside Reverse Transcriptase Inhibitors - Full Text View

Genetic Determinants of the Metabolism of Non-Nucleoside Reverse Transcriptase Inhibitors

This study is ongoing, but not recruiting participants.

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00730223

Purpose

To see if certain variations in the CYP2B6 gene contribute to differences in plasma drug levels and central nervous system side affects in people who take nevirapine or efavirenz.

Condition	Intervention	Phase
HIV Infections	Drug: Nevirapine and Efavirenz	Phase I

MedlinePlus related topics:

AIDS

Drug Information available for:

Efavirenz Nevirapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study

Official Title:	Genetic Determinants of the Metabolism of Non-Nucleoside Reverse Transcriptase Inhibitors

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Pharmacokinetics of single dose nevirapine and single dose efavirenz [ Time Frame: 5-6 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	33
Study Start Date:	March 2004
Estimated Study Completion Date:	August 2009
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Intervention Details:

single oral dose 200mg of nevirapine and single oral dose 600 mg of efavirenz

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy African American men and women.
18-55 years of age.
Willing and able to provide written informed consent.

Exclusion Criteria:

Currently or recently (within the previous 30 days) received medications known or likely to be metabolized by, or interact wth the CYP450 enzymes.
Prior or current hepatic or psychiatric disease illness that in the judgment of the investigator would interfere in the study performance.
Active alcohol or illicit drug abuse use that in the judgment of the investigator would interfere in the study performance.
ALT or AST >1.5 X upper limit of normal.
Positive pregnancy test in women of childbearing potential.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730223

Sponsors and Collaborators

Vanderbilt University

Investigators


Principal Investigator:	David W Haas, MD	Associate Professor of Medicine

More Information

Responsible Party:	Department of Medicine, Infectious Diseases Division ( David W. Haas, M.D. )
Study ID Numbers:	040062, GM31304, CFAR Discovery Grant
First Received:	August 4, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00730223
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Nevirapine

Efavirenz

pharmacokinetics

healthy

CYP2B6

HIV/AIDS

Study placed in the following topic categories:

Virus Diseases

Efavirenz

Nevirapine

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Healthy

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Slow Virus Diseases

Anti-HIV Agents

Molecular Mechanisms of Pharmacological Action

Immune System Diseases

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 31, 2008