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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

David Haas, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00730223

First received: August 4, 2008

Last updated: February 12, 2013

Last verified: February 2013

History of Changes

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 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Nevirapine Efavirenz Nevirapine hemihydrate

U.S. FDA Resources

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
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

Other Names:

Viramune
Sustiva

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.
Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >1.5 X upper limit of normal.
Positive pregnancy test in women of childbearing potential.

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: NCT00730223

Sponsors and Collaborators

Vanderbilt University

Investigators


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

More Information

No publications provided


Responsible Party:	David Haas, Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00730223 History of Changes
Other Study ID Numbers:	040062, GM31304, CFAR Discovery Grant
Study First Received:	August 4, 2008
Last Updated:	February 12, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:


Nevirapine Efavirenz pharmacokinetics	healthy CYP2B6 HIV/AIDS

Additional relevant MeSH terms:


Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases Efavirenz	Nevirapine Reverse Transcriptase Inhibitors Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 26, 2015

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