Longitudinal Studies of HIV-Associated Lung Infections and Complications (Lung HIV) (LHIV)
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|ClinicalTrials.gov Identifier: NCT00933595|
Recruitment Status : Completed
First Posted : July 7, 2009
Last Update Posted : September 1, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Complications HIV Infections||Other: Smoking Cessation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Longitudinal Studies of HIV-Associated Lung Infections and Complications (Lung HIV)|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||November 2013|
Experimental: Smoking Cessation
The overall smoking cessation rate for the intervention is 18.8 at 3 months, 13.1 at 6 months and 10.0 at 12 months.
Other: Smoking Cessation
A Motivational Interview session (~40-50 minutes) will be delivered by a trained nurse coordinator.
Treatment with varenicline (1 mg daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12)or nicotine replacement therapy (21 mg of a skin patch + nicotine gum 4 mg ad lib added for breakthrough craving up to 20 pieces/day.
- To develop and evaluate a specialized smoking cessation intervention for the treatment of nicotine dependence in HIV-seropositive smokers. [ Time Frame: 5 years ]
- 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: 5 years ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
Men and women at the AIDS Clinical Trials Unit(ACTU) will be eligible to participate if they meet four criteria: (a) 18 years of age and older; and (b) diagnosis of HIV; and (c) self-reported smoking on a daily basis; and (d) provide informed written consent.
Persons who meet one or more of the following criteria will be excluded from the study: (a) persons with active psychosis or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam); (b) unable to understand spoken English; (c) age less than 18 years.
Rationale: Persons with cognitive impairment may participate in the study if they are able to provide consent and answer questionnaire questions. No reason is identified to exclude persons with this characteristic. No special risks are posed to cognitively impaired persons who are able to provide consent. Persons who have active psychoses or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam are not able to provide informed written consent and are unlikely to benefit from the treatment. These persons will be referred to appropriate mental health services and invited to participate when their mental status has improved.
Persons who are unable to understand spoken English would not be able to complete the assessments or benefit from the treatments. Less than 1% of the clinic population will be excluded on this basis. However, persons excluded from the study on this basis will be referred for standard smoking cessation treatment delivered in their native tongue. These community resources may be identified through the Ohio State University Nursing Center for Tobacco Intervention.
Younger adolescents (<18 years) will not be invited to participate in the study because we believe that they require treatments that are qualitatively different from those designed for older adolescents and adults. The treatments that will be evaluated in the proposed research are well suited to older adolescents and adults, but not developmentally tailored to younger adolescents. Less than 1% of the clinic population will be excluded on this basis. Most HIV+ children living in Columbus, Ohio receive HIV medical care through the F.A.C.E.S. outpatient clinic at Columbus Children's Hospital. Standard, age appropriate, smoking cessation treatment is available through the Health and Wellness Center at Columbus Children's Hospital. In the unlikely circumstance that a child <18 years of age wishes to participate in the proposed study, s/he will be referred to Health and Wellness Center at Children's Hospital for treatment or the Ohio State University Nursing Center for Tobacco Intervention for age appropriate smoking cessation community resources.
Pregnant women may not be included as subjects. While smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes, little information is available on the safety or efficacy of varenicline. Therefore, participants who are pregnant will be excluded as subjects. Also, women who are breast-feeding will be excluded.
Other persons who are unable to use varenicline will be allowed to participate in the study but will not receive the varenicline component of treatment. A history and physical examination will be conducted as a component of the baseline evaluation.
People that have kidney problems or undergo kidney dialysis will not take the study drug, but will be given the option to take nicotine replacement therapy.
All persons excluded from the study will have the opportunity to receive smoking cessation treatment. We will provide referrals for treatment as clinically indicated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933595
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|Study Director:||Hannah Peavy, MD||NHLBI Project Officer|
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||National Heart, Lung, and Blood Institute (NHLBI)|
|Other Study ID Numbers:||
3R01HL090331-05S1 ( U.S. NIH Grant/Contract )
|First Posted:||July 7, 2009 Key Record Dates|
|Last Update Posted:||September 1, 2016|
|Last Verified:||January 2013|