Evidence map›Paper›PMID 28931220›Full record

Trial reportThe Journal of infectious diseases2017

Race/Ethnicity and the Pharmacogenetics of Reported Suicidality With Efavirenz Among Clinical Trials Participants.

Katie R Mollan, Camlin Tierney, Jacklyn N Hellwege, Joseph J Eron, Michael G Hudgens, Roy M Gulick, Richard Haubrich, Paul E Sax, Thomas B Campbell, Eric S Daar and 6 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
2.8field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Efavirenz Pharmacogenetics and Weight Gain Following Switch to Integrase Inhibitor-Containing Regimens.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Trial
  4. Trial
  5. Article
  6. Article
  7. Pharmacogenetics ofJournal of personalized medicine · 2022
    Article
  8. Article
  9. Article
  10. Review
  11. Review
  12. Observational
  13. Efavirenz Metabolism: Influence of Polymorphic CYP2B6 Variants and Stereochemistry.Drug metabolism and disposition: the biological fate of chemicals · 2019
    Review
  14. Article
  15. Article
  16. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 12 institutions in 1 country.

Katie R MollanCenter for AIDS Research.
Camlin TierneyCenter for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health.
Jacklyn N HellwegeDivision of Epidemiology, Department of Medicine.
Joseph J EronCenter for AIDS Research.
Michael G HudgensCenter for AIDS Research.
Roy M GulickWeill Cornell Medicine, Department of Medicine, New York.
Richard HaubrichGilead Sciences, Foster City.
Paul E SaxDivision of Infectious Diseases and Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Thomas B CampbellDepartment of Medicine, University of Colorado, Denver.
Eric S DaarLos Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, David Geffen School of Medicine at UCLA, California.
Kevin R RobertsonNeurology.
Diana VenturaCenter for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health.
Qing MaUniversity at Buffalo, Department of Pharmacy Practice, New York.
Digna R Velez EdwardsDepartment of Obstetrics and Gynecology, Vanderbilt Genetics Institute, Vanderbilt University Medical Center.
David W HaasDepartment of Medicine, Vanderbilt University School of Medicine.
AIDS Clinical Trials Group
Cancer Research And Biostatistics · USJohns Hopkins University Center for AIDS ResearchGilead Sciences (United States) · USHarvard University · USNeurology, Inc · USUCLA Medical Center · USUniversity at Buffalo, State University of New York · USUniversity of Colorado Denver · USUniversity of North Carolina at Chapel Hill · USVanderbilt University · USVanderbilt University Medical Center · USWeill Cornell Medicine · US

Funding

Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
University of Buffalo Clinical and Translational Science Institute - Supplement SchulyerUL1TR001412 · NCATS · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI MURPHY, TIMOTHY F · 2015 to 2024
$33.8M
Pharmacogenomics of HIV TherapyR01AI077505 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI HAAS, DAVID W · 2008 to 2025
$12.3M
Vanderbilt Training Program in Molecular and Genetic Epidemiology of CancerT32CA160056 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Xiao-Ou Shu · 2017 to 2026
$3.8M
Antiretroviral pharmacogenomics, pharmacokinetics and toxicity in neuroAIDSK08MH098794 · NIMH · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI MA, QING · 2012 to 2016
$599k
NCATS NIH HHS UL1 TR001412NCI NIH HHS T32 CA160056NIAID NIH HHS P30 AI050410NIAID NIH HHS R01 AI077505NIAID NIH HHS U01 AI068634NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI106701NIMH NIH HHS K08 MH098794
6 · The paper itself

Abstract

Background: We examined associations between suicidality and genotypes that predict plasma efavirenz exposure among AIDS Clinical Trials Group study participants in the United States. Methods: Four clinical trials randomly assigned treatment-naive participants to efavirenz-containing regimens; suicidality was defined as reported suicidal ideation or attempted or completed suicide. Genotypes that predict plasma efavirenz exposure were defined by CYP2B6 and CYP2A6 polymorphisms. Associations were evaluated with weighted Cox proportional hazards models stratified by race/ethnicity. Additional analyses adjusted for genetic ancestry and selected covariates. Results: Among 1833 participants, suicidality was documented in 41 in exposed analyses, and 34 in on-treatment analyses. In unadjusted analyses based on 12 genotype levels, suicidality increased per level in exposed (hazard ratio, 1.11; 95% confidence interval, .96-1.27) and on-treatment 1.16; 1.01-1.34) analyses. In the on-treatment analysis, the association was strongest among white but nearly null among black participants. Considering 3 metabolizer levels (extensive, intermediate and slow), slow metabolizers were at increased risk. Results were similar after baseline covariate-adjustment for genetic ancestry, sex, age, weight, injection drug use history, and psychiatric history or recent psychoactive medication. Conclusions: Genotypes that predict higher plasma efavirenz exposure were associated with increased risk of suicidality. Strength of association varied by race/ethnicity.

Indexed as

PharmacogeneticsAdultAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesCytochrome P-450 CYP2A6Cytochrome P-450 CYP2B6EthnicityFemaleGene FrequencyGenotypeHIV InfectionsHumansMalePolymorphism, Single NucleotideAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesCYP2A6 protein, humanCYP2B6 protein, humanCytochrome P-450 CYP2A6Cytochrome P-450 CYP2B6efavirenzCYP2B6efavirenzHIVpharmacogeneticssuicidality

Identifiers

PMID28931220
PMCPMC5853681
OpenAlexW2730104485

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.