Comparison of the Efficacy and Safety of Varenicline Versus Placebo for Smoking Cessation Among HIV-infected Patients. A Randomized Double Blind Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Varenicline
- Conditions
- HIV Infections
- Sponsor
- ANRS, Emerging Infectious Diseases
- Enrollment
- 248
- Locations
- 1
- Primary Endpoint
- Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HIV-infected patients
- •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
Arms & Interventions
Varenicline
Varenicline titrated to 2 x 0.5 mg twice daily for 12 weeks
Intervention: Varenicline
Placebo
placebo titrated to 2 pills twice daily for 12 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
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 Outcomes
- Frequency of depressive episodes. Diagnosed by a psychiatrist(continuously)
- Change in Lung capacity (FEV1 and FVC) between inclusion and week 48(week 48)
- Continuous abstinence from smoking from week 9 to week 12 without the use of any other smoking cessation treatments other than trials' treatment(from week 9 to week 12)
- Change in cardiovascular risk score (Framingham and PROCAM scores) between inclusion and week 48.(week 48)
- Quality of life evaluation (SF-12)(inclusion, W12, W24, W48)