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Completed

NCT Number: NCT04794543

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Changes in respiratory tract metabolite profiles in PLWH

    Time frame: Baseline only (at Visit 1)

    Metabolomic analyses of exhaled breath condensate and gas.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

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

Acronym: HBS Ancillary

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2021
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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