HIV+ Alveolar Macrophage Oxidant-mediated Apoptosis of Pulmonary Endothelium

NCT02056158 | Completed

• 2 other identifiers: 1307014135U01HL121828
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In HIV+ cigarette smokers, with no prior history of pulmonary infections, emphysema is often developed at an earlier age and is a significant cause of morbidity despite treatment with antiretroviral drugs. Preliminary data gathered from HIV+ individuals that smoke cigarettes strongly support the hypothesis that the combination of HIV infection and smoking creates increased stress in the lower respiratory tract. To examine the underlying factors that contribute to the accelerated development of emphysema in this cohort, samples from the lower respiratory tract will be provided by HIV+ and HIV- subjects. The samples collected will serve as biomarkers for assessing the onset of emphysema.

Conditions

HIV; COPD; Emphysema; Smoking

Keywords

HIV; COPD; Emphysema; Smoking

Outcome Measures

Primary Outcomes (1)

• Changes in oxidant stress in the lower respiratory tract in association with HIV infection and smoking

  Using samples obtained from subjects the extent and nature of the HIV/smoking-induced oxidant burden of the lower respiratory tract will be assessed.

  One year

Study Arms (8)

HIV Negative Early COPD Smokers

HIV Negative Early COPD Smokers

HIV Negative COPD Smokers

HIV Negative COPD Smokers

HIV Negative Nonsmokers

HIV Negative Nonsmokers

HIV Negative Smokers

HIV Negative Smokers

HIV Positive Smokers

HIV Positive Smokers

HIV Positive Nonsmokers

HIV Positive Nonsmokers

HIV Positive COPD Smokers

HIV Positive COPD Smokers

HIV Positive Early COPD Smokers

HIV Positive Early COPD Smokers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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)

Department of Genetic Medicne

New York, New York, 10021, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and biopsies from the lower respiratory tract.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; 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: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 5, 2014
• Study Start: January 13, 2014
• Primary Completion: October 5, 2015
• Study Completion: October 23, 2015
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

US (1)