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

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.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nevirapine and Efavirenz

Drug

single oral dose 200mg of nevirapine and single oral dose 600 mg of efavirenz

Other names: Viramune, Sustiva

Primary outcomes

Pharmacokinetics of single dose nevirapine and single dose efavirenz

Time frame: 5-6 weeks

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2009
First posted: Aug 8, 2008
Registry last updated: Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed