This trial is active, not recruiting.

Conditions smoking, hiv infections
Treatments varenicline tartrate, nicotine replacement therapy, biological control, motivational interview
Sponsor Philip Diaz
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date June 2008
End date April 2015
Trial size 365 participants
Trial identifier NCT00701896, 2007H0173, R01HL090313


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Healthy Control arm with 51 subjects who are HIV negative and do not smoke
biological control
No treatment intervention only information and procedures.
Healthy Control arm, includes 50 subjects who are HIV negative and are smokers.
biological control
No treatment intervention only information and procedures.
(Active Comparator)
Includes up to 365 subjects who are HIV positive and initiate smoking cessation
varenicline tartrate Chantix
1 mMg tablet form; daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12.
nicotine replacement therapy
Nicotine gum and nicotine patch
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
motivational interview
60 minute one-on-one Interview

Primary Outcomes

To develop and evaluate a specialized smoking cessation intervention for the treatment of nicotine dependence in HIV-seropositive smokers.
time frame: 48 Months

Secondary Outcomes

To examine the effects of smoking cessation on the course of lung function decline, the prevalence of respiratory symptoms and the occurrence/progression of emphysema in a cohort of HIV-seropositive individuals.
time frame: 48 Months
To explore the effects of smoking cessation on the biology of alveolar macrophages obtained from HIV-seropositive individuals
time frame: 48 Months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. 18 years of age and older; 2. diagnosis of HIV; 3. self-reported smoking on a daily basis; 4. provide informed written consent Exclusion Criteria: 1. persons with active psychosis or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam) 2. unable to understand spoken English 3. age less than 18 years. 4. pregnant women

Additional Information

Official title Smoking Cessation and the Natural History of HIV-Associated Emphysema
Principal investigator Philip T. Diaz, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Ohio State University.