NCT00730223

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_1 hiv-infections

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

2 years

First QC Date

August 4, 2008

Last Update Submit

February 12, 2013

Conditions

HIV Infections

Keywords

NevirapineEfavirenzpharmacokineticshealthyCYP2B6HIV/AIDS

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of single dose nevirapine and single dose efavirenz

    5-6 weeks

Interventions

Nevirapine and EfavirenzDRUG

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

Also known as: Viramune, Sustiva

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy African American men and women.
  • years of age.
  • Willing and able to provide written informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Nevirapineefavirenz

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • David W Haas, MD

    Associate Professor of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 4, 2008

First Posted

August 8, 2008

Study Start

March 1, 2004

Primary Completion

March 1, 2006

Study Completion

August 1, 2009

Last Updated

February 15, 2013

Record last verified: 2013-02