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

ClinicalTrials.gov processed this record on May 23, 2013