Evidence map›Paper›PMID 22007690›Full record

Trial reportAIDS patient care and STDs2012

Safety and tolerability of varenicline tartrate (Champix(®)/Chantix(®)) for smoking cessation in HIV-infected subjects: a pilot open-label study.

Qu Cui, Linda Robinson, Dawn Elston, Fiona Smaill, Jeffrey Cohen, Corinna Quan, Nancy McFarland, Lehana Thabane, Andrew McIvor, Johannes Zeidler and 1 more

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in AIDS patient care and STDs, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 9 pooled it
–field-weighted citation impact
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

39 citing papers in PubMed, 9 syntheses or guidelines pooled it.

  1. Pooled it
  2. Interventions for tobacco use cessation in people living with HIV.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023
    Pooled it
  4. A Qualitative Systematic Review of Cigarette Smoking Cessation Interventions for Persons Living with HIV.Journal of cancer education : the official journal of the American Association for Cancer Education · 2019
    Pooled it
  5. Interventions for tobacco use cessation in people living with HIV and AIDS.The Cochrane database of systematic reviews · 2016
    Pooled it
  6. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2016
    Pooled it
  7. Sex Differences in Varenicline Efficacy for Smoking Cessation: A Meta-Analysis.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2016
    Pooled it
  8. Pooled it
  9. Smoking-cessation interventions in people living with HIV infection: a systematic review.The Journal of the Association of Nurses in AIDS Care : JANAC
    Pooled it
  10. Trial
  11. Correlates of Adherence to Varenicline Among HIV+ Smokers.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2015
    Trial
  12. Safety of varenicline among smokers enrolled in the lung HIV study.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2013
    Trial
  13. Article
  14. Article
  15. Article
  16. COPD in People with HIV: Epidemiology, Pathogenesis, Management, and Prevention Strategies.International journal of chronic obstructive pulmonary disease · 2023
    Review
  17. Article
  18. Article
  19. Article
  20. Review
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

11 authors.

Qu CuiDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada. cuiq2@mcmaster.ca
Linda Robinson
Dawn Elston
Fiona Smaill
Jeffrey Cohen
Corinna Quan
Nancy McFarland
Lehana Thabane
Andrew McIvor
Johannes Zeidler
Marek Smieja

Funding

Canadian Institutes of Health Research
6 · The paper itself

Abstract

The prevalence of smoking in HIV-infected subjects is high. As a smoking cessation aid, varenicline (Champix(®), Pfizer, Saint-Laurent, QC, Canada or Chantix(®), Pfizer, Mission, KS) has not been previously evaluated in HIV-infected smokers. In this multicenter pilot open label study, varenicline 1.0 mg was used twice daily for 12 weeks with dose titration in the first week. Adverse events (AEs) during the treatment period were recorded. Changes from baseline in laboratory tests, vital signs, daily cigarette consumption, nicotine dependence, and withdrawal were measured through week 24. Self-reported abstinence was validated by serum cotinine at week 12. We enrolled 36 subjects with a mean of 29 pack-years of smoking and a minimum of 4 cigarettes per day. All but 1 were male, 33 (92%) were white. The most frequently reported AEs were nausea (33%), abnormal dreams (31%), affect lability (19%), and insomnia (19%). Six (17%) subjects discontinued varenicline due to AEs. No grade 3/4 laboratory abnormalities or serious AEs occurred during the study. There was no significant change in HIV viral load. CD4 counts increased by 69 cells/mm3 (p = 0.001) at week 24. Serum cotinine-verified 4-week continuous abstinence rate through weeks 9-12 was 42% (95% confidence interval [CI]: 26-58%). AEs and abstinence rates were comparable to those in published randomized controlled trials conducted in generally healthy HIV-negative smokers. Varenicline was safe and appears effective among HIV-infected smokers in this exploratory study, although AEs were common. The most common AE was nausea, with no adverse effect on HIV treatment outcome. Close monitoring of liver enzymes and blood pressure is recommended for HIV-positive smokers taking varenicline.

Indexed as

AdultAffectBenzazepinesCotinineDreamsFemaleFollow-Up StudiesHIV SeropositivityHumansIndicators and ReagentsMaleMiddle AgedNauseaNicotinic AgonistsOntarioPilot ProjectsBenzazepinesCotinineIndicators and ReagentsNicotinic AgonistsQuinoxalinesVarenicline

Identifiers

PMID22007690
PMCPMC3242617

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.