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Genetic Determinants of the Metabolism of Non-nucleoside Reverse Transcriptase Inhibitors
This study has been completed.
Sponsor:
Vanderbilt University
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
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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: 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
- Viramune
- Sustiva
single oral dose 200mg of nevirapine and single oral dose 600 mg of efavirenz
Other Names:
Eligibility| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00730223
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
| 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 |
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 |
ClinicalTrials.gov processed this record on June 26, 2017