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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Nevirapine and Efavirenz | Phase 1 |
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 |

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Drug: Nevirapine and Efavirenz
- Viramune
- Sustiva
- Pharmacokinetics of single dose nevirapine and single dose efavirenz [ Time Frame: 5-6 weeks ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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