Effects of Using E-Cigarettes on Lungs in People With HIV (HBS Ancillary)

NCT04794543 | Completed

• 2 other identifiers: PBRC 2020-028U54GM104940
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

This is an ancillary study, thus participants will be recruited from participants in the HBS Study. This project acutely assesses the role of the e-cigarettes and vaping on lung health. The proposed work will inform the design of future studies to better understand vaping's health consequences and to test novel interventions to mitigate vaping's contribution to acute and/or chronic lung injury.

Conditions

Hiv; Lung Injury

Outcome Measures

Primary Outcomes (1)

• Changes in respiratory tract metabolite profiles in PLWH

  Metabolomic analyses of exhaled breath condensate and gas.

  Baseline only (at Visit 1)

Study Arms (3)

e-cigarettes and/or e-liquid vaping smokers

actively use e-cigarettes or vape

cigarette smokers

actively smoke combustible tobacco and/or marijuana (cannabis)

Non-smokers

no use of e-cigarettes or vape or active smoking in the past 5 years (and less than a total of 10 pack-years lifetime use)

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

People living with HIV (PLWH) in the study site areas who are enrolled in the HBS study (main trial).

You may qualify if:

• documented HIV-infection
• in care at an HIV specialty clinic
• age ≥ 18 years.

You may not qualify if:

• a pacemaker or other implanted electronic device
• pregnant women, prisoners, cognitively-impaired subjects.
• For this ancillary, the experimental group must actively use at least one of the following: e-cigarettes, e-liquid vapes, burning leaf tobacco cigarettes, or inhaled burning leaf marijuana (cannabis). The control group will have no use of e-cigarettes or vape or active smoking in the past year.
• Participants must be willing to archive data and biological samples for future use.
• overt respiratory or oral cavity disease
• acute illness in the past 4 weeks
• active cancer
• active weight loss program
• any other medical, psychiatric or behavioral factors that, in the judgment of the PI may interfere with study participation or ability to follow the protocol

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (2)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Lsuhsc-No

New Orleans, Louisiana, 70112, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

breath samples, blood, stool

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Lung Injury

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Study Officials

• John Apolzan, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Director Clinical Nutrition and Metabolism Lab

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 12, 2021
• Study Start: April 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: December 4, 2023
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)