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

Hiv Clinical Trial

— HBS Ancillary  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04794543
• Other study ID #: PBRC 2020-028
• Secondary ID: U54GM104940
• Status: Active, not recruiting
• Start date: April 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: November 2023
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: July 1, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv
• Lung Injury

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	Lsuhsc-No	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

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