0 Ratings
ID

45692

Description

Principal Investigator: David W. Haas, MD, Vanderbilt University School of Medicine, Nashville, Tennessee, USA MeSH: Central Nervous System Diseases,Dizziness,Insomnia,Hallucinations,Headache https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001253 This is an evaluation of genetic associations with efavirenz (EFV) discontinuation for central nervous system (CNS) symptoms within 12 months of treatment. Patients were treated at an HIV primary care clinic in Nashville TN from 1998 to 2012. Previously known SNPs in *CYP2B6* and *CYP2A6* were used to define metabolizer genotypes (extensive, intermediate, slow metabolizer). Over 500,000 SNPs from genome-wide genotyping were used to define MDS (Multidimensional Scaling) coordinates to account for population stratification. Patients were defined as *cases* if they discontinued EFV for CNS symptoms within 12 months, otherwise they were defined as *controls* if they did not stop treatment. Among 563 evaluable participants, the hazard ratio for EFV discontinuation for CNS symptoms was 4.9 (95% C.I. 1.9 TO 12.4, p=0.001) in slow metabolizers compared to extensive metabolizers. This association was very significant in Whites 6.5 (95% CI: 2.3 to 18.8; p = 0.001), but not in Blacks 2.6 (95% C.I. 0.5 to 14.1; p = 0.27). The reason for this difference by race is not clear and warrants further investigation.

Link

dbGaP study = phs001253

Keywords

Versions (1)
  1. 5/8/23 5/8/23 - Simon Heim
Copyright Holder

David W. Haas, MD, Vanderbilt University School of Medicine, Nashville, Tennessee, USA

Uploaded on

May 8, 2023

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    dbGaP phs001253 Pharmacogenetics of Efavirenz Discontinuation for Reported CNS Symptoms

    English

    Eligibility Criteria

    6 forms  
    Inclusion and exclusion criteria
    Description

    Inclusion and exclusion criteria

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0680251
    *Inclusion Criteria*
    Description

    *Inclusion Criteria*

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    HIV-infected patients
    Description

    HIV-infected patients

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019693
    ART naÏve patients who Initiated EFV-containing ART regimens during clinical care at Vanderbilt Comprehensive Care Center in Nashville, TN from 1998 to 2012.
    Description

    ART naÏve patients who Initiated EFV-containing ART regimens during clinical care at Vanderbilt Comprehensive Care Center in Nashville, TN from 1998 to 2012.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1963724
    UMLS CUI [1,2]
    C0332256
    UMLS CUI [1,3]
    C0674428
    UMLS CUI [1,4]
    C1963724
    UMLS CUI [1,5]
    C1947933
    UMLS CUI [1,6]
    C1552443
    Patients who had at least one follow-up visit after ART initiation visit.
    Description

    Patients who had at least one follow-up visit after ART initiation visit.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0589121
    UMLS CUI [1,2]
    C1963724
    Patients who provided written informed consent for genetic testing through the CFAR Data and Specimen Repository.
    Description

    Patients who provided written informed consent for genetic testing through the CFAR Data and Specimen Repository.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C1320549
    UMLS CUI [1,3]
    C1541218
    UMLS CUI [1,4]
    C3847505
    Patients who had genotype data in *CYP2B6*, *CYP2A6* and whole genome exome data.
    Description

    Patients who had genotype data in *CYP2B6*, *CYP2A6* and whole genome exome data.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0017431
    UMLS CUI [1,2]
    C1382176
    UMLS CUI [1,3]
    C1413868
    UMLS CUI [1,4]
    C5446360
    *Exclusion Criteria*
    Description

    *Exclusion Criteria*

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    Initiated the EFV-containing regimen during participation in an ACTG clinical trial.
    Description

    Initiated the EFV-containing regimen during participation in an ACTG clinical trial.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0674428
    UMLS CUI [1,2]
    C1276413
    UMLS CUI [1,3]
    C0008976
    Back to the top of the page

    Similar models

    Eligibility Criteria

    6 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion and exclusion criteria
    C1512693 (UMLS CUI [1,1])
    C0680251 (UMLS CUI [1,2])
    *Inclusion Criteria*
    Item
    *Inclusion Criteria*
    boolean
    C1512693 (UMLS CUI [1,1])
    HIV-infected patients
    Item
    HIV-infected patients
    boolean
    C0019693 (UMLS CUI [1,1])
    ART naÏve patients who Initiated EFV-containing ART regimens during clinical care at Vanderbilt Comprehensive Care Center in Nashville, TN from 1998 to 2012.
    Item
    ART naÏve patients who Initiated EFV-containing ART regimens during clinical care at Vanderbilt Comprehensive Care Center in Nashville, TN from 1998 to 2012.
    boolean
    C1963724 (UMLS CUI [1,1])
    C0332256 (UMLS CUI [1,2])
    C0674428 (UMLS CUI [1,3])
    C1963724 (UMLS CUI [1,4])
    C1947933 (UMLS CUI [1,5])
    C1552443 (UMLS CUI [1,6])
    Patients who had at least one follow-up visit after ART initiation visit.
    Item
    Patients who had at least one follow-up visit after ART initiation visit.
    boolean
    C0589121 (UMLS CUI [1,1])
    C1963724 (UMLS CUI [1,2])
    Patients who provided written informed consent for genetic testing through the CFAR Data and Specimen Repository.
    Item
    Patients who provided written informed consent for genetic testing through the CFAR Data and Specimen Repository.
    boolean
    C0021430 (UMLS CUI [1,1])
    C1320549 (UMLS CUI [1,2])
    C1541218 (UMLS CUI [1,3])
    C3847505 (UMLS CUI [1,4])
    Patients who had genotype data in *CYP2B6*, *CYP2A6* and whole genome exome data.
    Item
    Patients who had genotype data in *CYP2B6*, *CYP2A6* and whole genome exome data.
    boolean
    C0017431 (UMLS CUI [1,1])
    C1382176 (UMLS CUI [1,2])
    C1413868 (UMLS CUI [1,3])
    C5446360 (UMLS CUI [1,4])
    *Exclusion Criteria*
    Item
    *Exclusion Criteria*
    boolean
    C0680251 (UMLS CUI [1,1])
    Initiated the EFV-containing regimen during participation in an ACTG clinical trial.
    Item
    Initiated the EFV-containing regimen during participation in an ACTG clinical trial.
    boolean
    C0674428 (UMLS CUI [1,1])
    C1276413 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial