Comparison of the Efficacy and Safety of Varenicline Versus Placebo for Smoking Cessation Among HIV-infected Patients. A Randomized Double Blind Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Varenicline
Varenicline titrated to 2 x 0.5 mg twice daily for 12 weeks
干预措施: Varenicline (Drug)
Placebo
placebo titrated to 2 pills twice daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment
时间窗: from week 9 to week 48
次要结局
- 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)