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Trial record 1 of 1 for:    NCT00918307
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Efficacy and Safety of Varenicline Among HIV-infected Patients (Inter-ACTIV)

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ClinicalTrials.gov Identifier: NCT00918307
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : July 29, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Tracking Information
First Submitted Date  ICMJE June 9, 2009
First Posted Date  ICMJE June 11, 2009
Last Update Posted Date July 29, 2014
Study Start Date  ICMJE October 2009
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2012)
Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment [ Time Frame: from week 9 to week 48 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2009)
Continuous abstinence from smoking from week 9 to week 48 [ Time Frame: from week 9 to week 48 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2012)
  • Continuous abstinence from smoking from week 9 to week 12 without the use of any other smoking cessation treatments other than trials' treatment [ Time Frame: from week 9 to week 12 ]
  • Change in Lung capacity (FEV1 and FVC) between inclusion and week 48 [ Time Frame: week 48 ]
  • Frequency of depressive episodes. Diagnosed by a psychiatrist [ Time Frame: continuously ]
  • Change in cardiovascular risk score (Framingham and PROCAM scores) between inclusion and week 48. [ Time Frame: week 48 ]
  • Quality of life evaluation (SF-12) [ Time Frame: inclusion, W12, W24, W48 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2009)
  • Continuous abstinence from smoking from week 9 to week 12 [ Time Frame: from week 9 to week 12 ]
  • Change in Lung capacity (FEV1 and FVC) between inclusion and week 48 [ Time Frame: week 48 ]
  • Frequency of depressive episodes. Diagnosed by a psychiatrist [ Time Frame: continuously ]
  • Change in cardiovascular risk score (Framingham and PROCAM scores) between inclusion and week 48. [ Time Frame: week 48 ]
  • Quality of life evaluation (SF-12) [ Time Frame: inclusion, W12, W24, W48 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Varenicline Among HIV-infected Patients
Official Title  ICMJE Comparison of the Efficacy and Safety of Varenicline Versus Placebo for Smoking Cessation Among HIV-infected Patients. A Randomized Double Blind Controlled Trial
Brief Summary Cigarette smoking is a major cause of illness among HIV-infected patients (non-AIDS defining malignancies (especially lung cancer), non-AIDS bacterial infections and cardio-vascular diseases). Approximately 50% of HIV-infected patients are regular tobacco smokers. Tobacco smoking cessation has well known benefits on mortality and morbidity in the general population where tobacco cessation assistance programs are increasingly implemented. However, smoking cessation interventions have never been evaluated among HIV-infected patients. This trial aims at evaluating the efficacy and safety of varenicline for smoking cessation compared with placebo.
Detailed Description Cigarette smoking is a major cause of illness among HIV-infected patients (non-AIDS defining malignancies (especially lung cancer), non-AIDS bacterial infections and cardio-vascular diseases). Approximately 50% of HIV-infected patients are regular tobacco smokers. Tobacco smoking cessation has well known benefits on mortality and morbidity in the general population where tobacco cessation assistance programs are increasingly implemented. However, smoking cessation interventions have never been evaluated among HIV-infected patients. This trial aims at evaluating the efficacy and safety of varenicline for smoking cessation compared with placebo. A pharmacokinetic study will be conducted to evaluate the effect of smoking cessation on the plasma concentration of antiretroviral treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Tobacco Dependence
Intervention  ICMJE
  • Drug: Varenicline
    Day 1 to day 3 : 0.5 mg daily ; Day 4 to day 7 : 0.5 mg twice daily ; Day 8 to week 12 : 2 x 0.5 mg twice daily
    Other Name: Champix
  • Drug: Placebo
    Day 1 to day 3 : 1 pill daily ; Day 4 to day 7 : 2 pills daily ; Day 8 to week 12 : 2 pills twice daily
Study Arms  ICMJE
  • Experimental: Varenicline
    Varenicline titrated to 2 x 0.5 mg twice daily for 12 weeks
    Intervention: Drug: Varenicline
  • Placebo Comparator: Placebo
    placebo titrated to 2 pills twice daily for 12 weeks
    Intervention: Drug: Placebo
Publications * Mercié P, Arsandaux J, Katlama C, Ferret S, Beuscart A, Spadone C, Duvivier C, Reynes J, Wirth N, Moinot L, Bénard A, Zucman D, Duval X, Molina JM, Spire B, Fagard C, Chêne G; ANRS 144 Inter-ACTIV study group. Efficacy and safety of varenicline for smoking cessation in people living with HIV in France (ANRS 144 Inter-ACTIV): a randomised controlled phase 3 clinical trial. Lancet HIV. 2018 Mar;5(3):e126-e135. doi: 10.1016/S2352-3018(18)30002-X. Epub 2018 Jan 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2013)
248
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2009)
254
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV-infected patients
  • adults
  • regular smokers (at least 10 cigarettes a day during the last year)
  • motivated to stop smoking
  • followed in one of the participating clinical ward,
  • signed written inform consent

Exclusion Criteria:

  • current co-dependency to another psychoactive substance
  • ongoing depressive episode
  • history of suicidal attempt
  • ongoing treatment by interferon
  • treatment by efavirenz for less than three months or not tolerated
  • previous use of varenicline
  • ongoing treatment by bupropion-SR or nicotinic substitute
  • ongoing pregnancy
  • ongoing breastfeeding
  • hypersensitivity to varenicline or to one of its excipients
  • drivers, air traffic controller
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00918307
Other Study ID Numbers  ICMJE 2008-007948-34
ANRS 144
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Study Sponsor  ICMJE French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Patrick MERCIE, MD CHU de Bordeaux, F-33000
Study Chair: Geneviève CHENE, MD, PHD INSERM U897
PRS Account French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP