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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment
from week 9 to week 48
Patrick MERCIE, MD
CHU de Bordeaux, F-33000
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)