Conditions: Smoking HIV Infections
Keywords: HIV Positive Smokers Varenicline
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 294
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Healthy Control arm with 51 subjects who are HIV negative and do not smoke arm 2: Healthy Control arm, includes 50 subjects who are HIV negative and are smokers. arm 3: Includes up to 365 subjects who are HIV positive and initiate smoking cessation arm 4: 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

Interventions: intervention 1: Varenicline tartrate intervention 2: Nicotine Replacement Therapy intervention 3: Biological Control intervention 4: Motivational Interview
Intervention descriptions: intervention 1: 1 mMg tablet form; daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12. intervention 2: Nicotine gum and nicotine patch intervention 3: No treatment intervention only information and procedures. intervention 4: 60 minute one-on-one Interview

Protocol document: