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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:


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:
    Drug: Nevirapine and Efavirenz
    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