NCT00933595

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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. There is only one clinical trial being performed in this network at Ohio State University and it will be reported here.

Detailed description

The Ohio State University Clinical Research Center (CRC), Patient Selection Study Intervention Subjects: 365 HIV+ male and female smokers will be enrolled to the study and will be recruited over a two - four year period. Inclusion criteria 1. 18 years of age and older 2. Diagnosis of HIV (Since the vast majority of our subjects will be recruited through the OSU Infectious disease clinics and HIV clinical research unit documentation of HIV status will not be a problem) 3. Self-reported smoking (≥ 5 cigarettes per day to avoid inclusion of occasional, 'social' users and 'chippers'); 4. Able and willing to provide informed written consent. Exclusion criteria: 1. Inability to provide informed consent 2. Inability to understand spoken English 3. Currently diagnosed interstitial lung disease (i.e. sarcoidosis, idiopathic pulmonary fibrosis) or lung cancer. Control Subjects Group A: We will utilize normal subjects for the control study for the Diffusion Capacity of Lung for Carbon Monoxide (DLCO) and Diffusion capacity of Lung for Nitric Oxide (DLNO), recruited from the general population. We will recruit 5 males and 5 females in each decade of life from 21-30, 31-40, 41-50, 51-60, 61-70 (TOTAL= 50 subjects). Inclusion criteria 1. 21-70 years of age and older 2. HIV Seronegative 3. Able and willing to provide informed written consent. Exclusion criteria: 1. Inability to provide informed consent 2. Inability to understand spoken English 3. Current smoker or have smoked in the last 10 years or have a \> 10 pack year history of smoking. 4. Currently diagnosed interstitial lung disease (i.e. sarcoidosis, idiopathic pulmonary fibrosis) or lung cancer. Control Subjects Group B: We will utilize normal subjects for the control study for DLCO and DLNO, recruited from the general population. We will recruit 5 males and 5 females in each decade of life from 21-30, 31-40, 41-50, 51-60, 61-70 (TOTAL= 50 subjects). Inclusion criteria 1. 21-70 years of age and older 2. HIV Seronegative 3. Current or former smoker with at least a 5 pack year history of smoking 4. Able and willing to provide informed written consent. Exclusion criteria: 1. Inability to provide informed consent 2. Inability to understand spoken English 3. Currently diagnosed interstitial lung disease (i.e. sarcoidosis, idiopathic pulmonary fibrosis) or lung cancer.

Conditions

• Pulmonary Complications
• HIV Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-09-01
• Primary completion: 2012-06-01
• Completion: 2013-11-01
• First posted: 2009-07-07
• Last updated: 2016-09-01

Locations

1 site across 1 country: United States