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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00730223

First Posted: August 8, 2008

Last Update Posted: February 15, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

David Haas, Vanderbilt University

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 Intervention Model: Crossover Assignment Masking: None (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

U.S. FDA Resources

Further study details as provided by David Haas, Vanderbilt University:

Primary Outcome Measures:

Pharmacokinetics of single dose nevirapine and single dose efavirenz [ Time Frame: 5-6 weeks ]


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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
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

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): NCT00730223

Sponsors and Collaborators

Vanderbilt University

Investigators


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

More Information


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
First Submitted:	August 4, 2008
First Posted:	August 8, 2008
Last Update Posted:	February 15, 2013
Last Verified:	February 2013

Keywords provided by David Haas, Vanderbilt University:


Nevirapine Efavirenz pharmacokinetics	healthy CYP2B6 HIV/AIDS

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 Efavirenz Nevirapine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Anti-HIV Agents

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