Longitudinal Studies of HIV-Associated Lung Infections and Complications (Lung HIV)

The Lung HIV Study was established to examine a broad range of separate yet overlapping
pulmonary complications being studied at eight separate Clinical Sites. A collection of
datasets and biological specimens will be created for use during this project as well as for
future investigations. The program is structured to facilitate both the development of these
shared resources and the completion of the individual projects. Results of these efforts
will be disseminated through publication in leading medical journals.

The concept of the Lung HIV study was developed by NHLBI to efficiently support multiple R01
efforts while simultaneously creating a shared database and specimen repository. The Lung
HIV program will build on the knowledge and experience from existing studies and facilitate
the start-up of new studies to further the understanding of the relationship between
pulmonary disease and HIV infection. The Lung HIV mission is to achieve a clear
understanding of the clinical manifestations of HIV-associated pulmonary complications by
fostering multidisciplinary research collaboration and establishing a high quality
centralized specimen repository with an associated clinical dataset based on shared
definitions. All but one study are cross-sectional or cohort designs. One clinical trial is
listed below.

Inclusion Criteria

Men and women at the 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.

Exclusion criteria

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.