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Efficacy and Safety of Varenicline Among HIV-infected Patients (Inter-ACTIV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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):
ANRS, Emerging Infectious Diseases

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Tobacco Dependence Drug: Varenicline Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy and Safety of Varenicline Versus Placebo for Smoking Cessation Among HIV-infected Patients. A Randomized Double Blind Controlled Trial
Study Start Date : October 2009
Actual Primary Completion Date : January 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Varenicline
Varenicline titrated to 2 x 0.5 mg twice daily for 12 weeks
 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
Placebo Comparator: Placebo
placebo titrated to 2 pills twice daily for 12 weeks
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change in Lung capacity (FEV1 and FVC) between inclusion and week 48 [ Time Frame: week 48 ]
  3. Frequency of depressive episodes. Diagnosed by a psychiatrist [ Time Frame: continuously ]
  4. Change in cardiovascular risk score (Framingham and PROCAM scores) between inclusion and week 48. [ Time Frame: week 48 ]
  5. Quality of life evaluation (SF-12) [ Time Frame: inclusion, W12, W24, W48 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918307


Locations
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France
CHU de Bordeaux
Bordeaux, France, 33075
Sponsors and Collaborators
ANRS, Emerging Infectious Diseases
Pfizer
Investigators
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Principal Investigator: Patrick MERCIE, MD CHU de Bordeaux, F-33000
Study Chair: Geneviève CHENE, MD, PHD INSERM U897
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier: NCT00918307    
Other Study ID Numbers: 2008-007948-34
ANRS 144
First Posted: June 11, 2009    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014
Keywords provided by ANRS, Emerging Infectious Diseases:
Tobacco Dependence
HIV infection
varenicline
Additional relevant MeSH terms:
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HIV Infections
Tobacco Use Disorder
Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs