Smoking Cessation and the Natural History of HIV-Associated Emphysema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- To Determine the Safety of Varenicline in PLWH Who Smoke
研究概览
简要总结
People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.
详细描述
HIV-infected smokers are at increased risk for life-threatening diseases, such as pneumonia. To date, very little is known about the tobacco consumption characteristics of this at-risk population of smokers, but it has been well documented that they are at high risk for smoking-related co-morbidities. In addition, few effective cessation strategies have been described in HIV-infected populations. A specialized smoking cessation that combines recommendations from an existing scientifically-valid clinical guideline with Motivational Interviewing a new pharmacotherapeutic agent, may be an effective mechanism to apply to this vulnerable population of smokers. This initial, efficacy investigation has the potential to guide future treatment and research pertaining to tobacco cessation, respiratory illness and HIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years of age and older;
- •diagnosis of HIV;
- •self-reported smoking on a daily basis;
- •provide informed written consent
排除标准
- •persons with active psychosis or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam)
- •unable to understand spoken English
- •age less than 18 years.
- •pregnant women
研究组 & 干预措施
Healthy Control - Non-smoking
Healthy Control arm with 51 subjects who are HIV negative and do not smoke
干预措施: Biological Control (Other)
Healthy Control - Smoker
Healthy Control arm, includes 50 subjects who are HIV negative and are smokers.
干预措施: Biological Control (Other)
HIV Smoking Cessation Arm
Includes up to 365 subjects who are HIV positive and initiate smoking cessation
干预措施: Varenicline tartrate (Drug)
HIV Smoking Cessation Arm
Includes up to 365 subjects who are HIV positive and initiate smoking cessation
干预措施: Nicotine Replacement Therapy (Drug)
Motivational Intervention
Includes up to 100 subjects who are HIV positive, do not wish to quit smoking but are willing to undergo one-on-one Motivational Intervention
干预措施: Motivational Interview (Behavioral)
结局指标
主要结局
To Determine the Safety of Varenicline in PLWH Who Smoke
时间窗: 3 months
To determine the safety and tolerability of varenicline compared to nicotine replacement
次要结局
- To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke(12 months)
研究者
Philip Diaz
Director, Pulmonary Rehabilitation Services; Medical Director, Respiratory Therapy; Associate Director, General Clinical Research Center
Ohio State University