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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00933595
First received: July 2, 2009
Last updated: August 14, 2009
Last verified: July 2009

July 2, 2009
August 14, 2009
September 2007
June 2012   (final data collection date for primary outcome measure)
To develop and evaluate a specialized smoking cessation intervention for the treatment of nicotine dependence in HIV-seropositive smokers. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00933595 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Longitudinal Studies of HIV-Associated Lung Infections and Complications (Lung HIV)
Longitudinal Studies of HIV-Associated Lung Infections and Complications (Lung HIV)

The Lung HIV goal is to facilitate the data and specimen collection efforts of eight individual HIV and pulmonary studies that operate under the direction of the NHLBI. The Lung HIV study will build on existing studies to facilitate the start-up of new projects to further the understanding of the relationship between pulmonary disease and HIV infection.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • Lung
  • HIV Infections
Behavioral: Smoking Cessation
The smoking cessation treatment will include 12 weeks of varenicline treatment and proactive telephone counseling.
Other Name: Bupropion SR, Chiantix
Experimental: Medication
Patients will be offered medication and lifestyle counseling to assist them with smoking cessation
Intervention: Behavioral: Smoking Cessation
Crothers K, Thompson BW, Burkhardt K, Morris A, Flores SC, Diaz PT, Chaisson RE, Kirk GD, Rom WN, Huang L; Lung HIV Study. HIV-associated lung infections and complications in the era of combination antiretroviral therapy. Proc Am Thorac Soc. 2011 Jun;8(3):275-81. doi: 10.1513/pats.201009-059WR. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
365
June 2012
June 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
Yes
Contact: Bruce Thompson, PhD 443-435-0663 bthompson@c-tasc.com
Contact: Kate Burkhardt, CCRP 410-464-4197 kburkhardt@c-tasc.com
United States
 
NCT00933595
652, 1R01HL09033-01, R01 HL090312, R01 HL090483, R01 HL090316, R01 HL090313, R01 HL090335, R01 HL090480, R01 HL090339, R01 HL090342
Yes
Bruce Thompson, PhD, Clinical Trials and Surveys Corp (C-TASC)
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Study Director: Hannah Peavy, MD NHLBI Project Officer
National Heart, Lung, and Blood Institute (NHLBI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP