HIV-related Accelerated Aging of the Airway Epithelium

NCT01974219 | Completed

• 2 other identifiers: 13060139865R01HL118857
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

In cigarette smokers that are HIV+, one of the most common HIV-associated non-AIDS conditions is the accelerated development of chronic obstructive pulmonary disease (COPD), a disorder associated with significant morbidity and mortality. Based on the knowledge that COPD in smokers starts in the small airway epithelium, this study is focused on examining the hypothesis that the accelerated development of COPD associated with HIV infection results, in part, from an interaction of HIV directly on the small airway epithelium or through infection of cellular components of the immune system, with mediators released by these immune cells evoking premature biologic aging of the small airway epithelium. By identifying the early events in the pathogenesis of the HIV-associated accelerated COPD in smokers, we aim to identify biologic targets to which pharmacologic therapies could be addressed.

Conditions

HIV; COPD; Chronic Obstructive Pulmonary Disease; Smoking

Keywords

HIV; COPD; Chronic Obstructive Pulmonary Disease; Smoking

Outcome Measures

Primary Outcomes (1)

• Gene expression changes in airway epithelium

  We examine the pathogenesis of the accelerated development of COPD in smokers with HIV infection and the premature biologic aging of the small airway epithelium (SAE) mediated by the effects of direct HIV infection of the SAE and/or through the interaction of HIV-infected T cells and/or alveolar macrophages (AM) with the SAE, resulting in the disordered biology of the SAE that is central to the pathogenesis of COPD.

  One Year

Study Arms (3)

Healthy nonsmokers

Healthy nonsmokers

Healthy smokers

Healthy smokers

COPD smokers

COPD smokers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

New York Metropolitan area residents

You may qualify if:

• HEALTHY VOLUNTEER RESEARCH SUBJECTS
• All study subjects should be able to provide informed consent
• Males or females ages 18 years and older
• Must provide HIV informed consent
• VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE
• Must provide informed consent
• Males and females age 18 years and older
• Lung disease proven by at least one of the following: symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and/or (6) diseases of organs with known association with lung disease
• Must provide HIV informed consent

You may not qualify if:

• HEALTHY VOLUNTEER RESEARCH SUBJECTS
• Individuals not deemed in good overall health by the investigator will not be accepted into the study.
• Habitual use of drugs and/or alcohol within the past six months (Acceptable: - Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria).
• Individuals with history of chronic lung disease, including asthma or with recurrent or recent (within three months) acute pulmonary disease will not be accepted into the study.
• Individuals with allergies to atropine or any local anesthetic will not be accepted into the study.
• Individuals with allergies to pilocarpine, isoproterenol, terbutaline, atropine or aminophylline will not be accepted into the study.
• Females who are pregnant or nursing will not be accepted into the study
• VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE
• Any history of allergies to xylocaine, lidocaine, versed, valium, atropine, pilocarpine, isoproterenol, terbutaline, aminophylline, or any local anesthetic will not be included in the study.
• Habitual use of drugs and/or alcohol within the past six months (Acceptable: Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria)
• Females who are pregnant or nursing

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine

New York, New York, 10065, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine, Cells

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Ronald G Crystal, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 1, 2013
• Study Start: December 23, 2013
• Primary Completion: February 14, 2019
• Study Completion: February 14, 2019
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

US (1)