HivHBS AncillaryNCT04794543
Effects of Using E-Cigarettes on Lungs in People With HIV (HBS Ancillary)
An observational study of Hiv and Lung Injury, run by Pennington Biomedical Research Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv, Lung Injury
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2022to 4 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People living with HIV (PLWH) in the study site areas who are enrolled in the HBS study (main trial).
Who may be able to join
None listed.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Lsuhsc-No
New Orleans, Louisiana, 70112
About this study
Official title: Effects of E-Cigarettes on the Lung Metabolome in People Living With HIV
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
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in respiratory tract metabolite profiles in PLWH
Metabolomic analyses of exhaled breath condensate and gas.
Measured: Baseline only (at Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Apr 2022
- Primary completion31 Aug 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, John Apolzan, Pennington Biomedical Research Center
- Investigators
- John Apolzan, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794543
- Sponsor's protocol ID
- PBRC 2020-028
- Other IDs
- U54GM104940
- Acronym
- HBS Ancillary
- Status last verified
- Aug 2024
- First submitted
- 4 Mar 2021
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of E-Cigarettes on the Lung Metabolome in People Living With HIV
- ClinicalTrials.gov ID
- NCT04794543
- Acronym / sponsor ID
- HBS Ancillary / PBRC 2020-028
- Conditions
- Hiv, Lung Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People living with HIV (PLWH) in the study site areas who are enrolled in the HBS study (main trial).
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in respiratory tract metabolite profiles in PLWH
Time frame: Baseline only (at Visit 1)
Metabolomic analyses of exhaled breath condensate and gas.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Apolzan, PhD principal investigator
Pennington Biomedical Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv and Lung Injury, run by Pennington Biomedical Research Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in respiratory tract metabolite profiles in PLWH (time frame: Baseline only (at Visit 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.