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

This study has been completed.
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)
ClinicalTrials.gov Identifier:
NCT00918307
First received: June 9, 2009
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
HIV Infections
Tobacco Dependence
Drug: Varenicline
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change in Lung capacity (FEV1 and FVC) between inclusion and week 48 [ Time Frame: week 48 ] [ Designated as safety issue: No ]
  • Frequency of depressive episodes. Diagnosed by a psychiatrist [ Time Frame: continuously ] [ Designated as safety issue: Yes ]
  • Change in cardiovascular risk score (Framingham and PROCAM scores) between inclusion and week 48. [ Time Frame: week 48 ] [ Designated as safety issue: No ]
  • Quality of life evaluation (SF-12) [ Time Frame: inclusion, W12, W24, W48 ] [ Designated as safety issue: No ]

Enrollment: 248
Study Start Date: October 2009
Study Completion Date: July 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918307

Locations
France
CHU de Bordeaux
Bordeaux, France, 33075
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Pfizer
Investigators
Principal Investigator: Patrick MERCIE, MD CHU de Bordeaux, F-33000
Study Chair: Geneviève CHENE, MD, PHD INSERM U897
  More Information

Additional Information:
No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT00918307     History of Changes
Other Study ID Numbers: 2008-007948-34, ANRS 144
Study First Received: June 9, 2009
Last Updated: July 28, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Tobacco Dependence
HIV infection
varenicline

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Tobacco Use Disorder
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014