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

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ClinicalTrials.gov Identifier: NCT00730223
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
David Haas, Vanderbilt University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: Nevirapine and Efavirenz Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
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
Study Start Date : March 2004
Actual Primary Completion Date : March 2006
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Drug: Nevirapine and Efavirenz
    single oral dose 200mg of nevirapine and single oral dose 600 mg of efavirenz
    Other Names:
    • Viramune
    • Sustiva

Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics of single dose nevirapine and single dose efavirenz [ Time Frame: 5-6 weeks ]

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: August 8, 2008    Key Record Dates
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