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

Effects of E-Cigarettes on the Lung Metabolome in People Living With HIV

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04794543

Acronym

HBS Ancillary

Enrollment

Registered

2021-03-12

Start date

2022-04-01

Completion date

2023-12-04

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv, Lung Injury

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

This project is an ancillary study to the HBS Study. Inclusion Criteria for that IRB approved study are: * documented HIV-infection * in care at an HIV specialty clinic * age ≥ 18 years.

Exclusion criteria

for the HBS Study are: * 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. Exclusion from the ancillary are: * 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

Design outcomes

Primary

Measure	Time frame	Description
Changes in respiratory tract metabolite profiles in PLWH	Baseline only (at Visit 1)	Metabolomic analyses of exhaled breath condensate and gas.

Countries

United States

Outcome results