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Comparison of the Efficacy and Safety of Varenicline Versus Placebo for Smoking Cessation Among HIV-infected Patients. A Randomized Double Blind Controlled Trial


Phase 3
18 Years
N/A
Open (Enrolling)
Both
HIV Infections, Tobacco Dependence

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Trial Information

Comparison of the Efficacy and Safety of Varenicline Versus Placebo for Smoking Cessation Among HIV-infected Patients. A Randomized Double Blind Controlled Trial


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment

Outcome Time Frame:

from week 9 to week 48

Safety Issue:

No

Principal Investigator

Patrick MERCIE, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU de Bordeaux, F-33000

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2008-007948-34

NCT ID:

NCT00918307

Start Date:

October 2009

Completion Date:

January 2014

Related Keywords:

  • HIV Infections
  • Tobacco Dependence
  • Tobacco Dependence
  • HIV infection
  • varenicline
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Tobacco Use Disorder

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