Genetic Determinants of the Metabolism of Non-nucleoside... | NCT00730223

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

NCT00730223

Sponsor

Vanderbilt University

Status

Completed

Last Update Posted

Feb 15, 2013Estimated

Enrollment

33Actual

Phase

Phase 1

Conditions

HIV Infections

Interventions

Nevirapine and Efavirenz

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Mar 2006Actual

Completion Date

Aug 2009Actual

First Submitted Date

Aug 4, 2008

First Submission Date that Met QC Criteria

Aug 7, 2008

First Posted Date

Aug 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2013

Last Update Posted Date

Feb 15, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nevirapine and Efavirenz	Drug	single oral dose 200mg of nevirapine and single oral dose 600 mg of efavirenz		Viramune Sustiva

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of single dose nevirapine and single dose efavirenz		5-6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David W Haas, MD	Associate Professor of Medicine	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019829	Nevirapine
C098320	efavirenz

Ancestor Terms

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
GM31304
CFAR Discovery Grant