HIVResppedHIVNCT05869084
Assessment of Bronchial Obstruction in Adolescents With HIV
A study testing pulmonary function tests in people with HIV, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In children, data from the literature find a higher prevalence of asthma in the population treated for HIV. Bronchial hyperreactivity, indicative of chronic inflammation and bronchial obstruction, is also present. Read more about this study
- Who is it for?
- Ages 11 to 25 years
- Conditions the study is for
- HIV
- What is being tested?
- pulmonary function tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 1 Jul 2022
- Phase
- Interventional
- 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 11 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children over 11 and Under 25-year-old infected with HIV and on antiretrovirals and followed up at Robert Debré hospital for this pathology
- Consent of the holders of parental authority and Patients informed and not objecting to participate in research Exclusion Criteria : •
- Age ≤ 11 years old
- Not treated for HIV
- Patients under guardianship / curatorship
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
In children, data from the literature find a higher prevalence of asthma in the population treated for HIV. Bronchial hyperreactivity, indicative of chronic inflammation and bronchial obstruction, is also present.
Screening for early peripheral obstruction could therefore make it possible to initiate appropriate anti-inflammatory treatment, if necessary, and early preventive management.
Read the detailed description
In adults chronically infected with HIV, there is an increased prevalence impaired respiratory function, with a greater occurrence of COPD than in the uninfected population. In children, data from the literature find a prevalence of greater atopy in the HIV-infected pediatric population. Furthermore, a bronchial hyperreactivity or even peripheral bronchial obstruction, indicative of a local chronic inflammation has been found in young adolescents treated since the birth for HIV infection in utero. Screening for early peripheral obstruction in HIV-infected adolescents could therefore make it possible to initiate, if necessary, a anti-inflammatory treatment, and early management to prevent the occurrence of impaired respiratory function in adulthood For this this single-center prospective study chose to perform respiratory function explorations with forced oscillometry with the Endpoint main factor of the peripheral obstruction the R5HZ parameter expressed in % predicted. Patients from 11 to 25 years to whom it was proposed added to that to answer a questionnaire of respiratory quality of life
- Conditions
- HIV
- Being tested
- pulmonary function tests
- Keywords
- antiretrovirals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary function testsDiagnostic test
pulmonary function tests
| Study group | Role | What they receive |
|---|---|---|
| pulmonary function tests | Experimental | Not described Receives: Diagnostic Test: pulmonary function tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resistance measured by forced oscillometry (5hZ)
Resistance measured by forced oscillometry (5hZ)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Mar 2022
- Primary completion1 Jun 2022
- Study completion1 Jul 2022
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronique HOUDOUIN, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869084
- Sponsor's protocol ID
- APHP211566
- Other IDs
- IDRCB: 2021-A02635-36
- Acronym
- ResppedHIV
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bronchial Obstruction in Adolescents With HIV
- ClinicalTrials.gov ID
- NCT05869084
- Acronym / sponsor ID
- ResppedHIV / APHP211566
- Conditions
- HIV
- Keywords
- antiretrovirals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 22 May 2023 (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.
In children, data from the literature find a higher prevalence of asthma in the population treated for HIV. Bronchial hyperreactivity, indicative of chronic inflammation and bronchial obstruction, is also present.
Screening for early peripheral obstruction could therefore make it possible to initiate appropriate anti-inflammatory treatment, if necessary, and early preventive management.
Detailed description
In adults chronically infected with HIV, there is an increased prevalence impaired respiratory function, with a greater occurrence of COPD than in the uninfected population. In children, data from the literature find a prevalence of greater atopy in the HIV-infected pediatric population. Furthermore, a bronchial hyperreactivity or even peripheral bronchial obstruction, indicative of a local chronic inflammation has been found in young adolescents treated since the birth for HIV infection in utero. Screening for early peripheral obstruction in HIV-infected adolescents could therefore make it possible to initiate, if necessary, a anti-inflammatory treatment, and early management to prevent the occurrence of impaired respiratory function in adulthood For this this single-center prospective study chose to perform respiratory function explorations with forced oscillometry with the Endpoint main factor of the peripheral obstruction the R5HZ parameter expressed in % predicted. Patients from 11 to 25 years to whom it was proposed added to that to answer a questionnaire of respiratory quality of life
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary function tests | Experimental | Diagnostic Test: pulmonary function tests |
Who may qualify
- Ages
- 11 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Children over 11 and Under 25-year-old infected with HIV and on antiretrovirals and followed up at Robert Debré hospital for this pathology
- Consent of the holders of parental authority and Patients informed and not objecting to participate in research Exclusion Criteria : •
- Age ≤ 11 years old
- Not treated for HIV
- Patients under guardianship / curatorship
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulmonary function testspulmonary function tests | Diagnostic test | pulmonary function tests |
Primary outcome
Resistance measured by forced oscillometry (5hZ)
Time frame: 24 hours
Resistance measured by forced oscillometry (5hZ)
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 22 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Veronique HOUDOUIN, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary function tests in people with HIV, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 0 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 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Resistance measured by forced oscillometry (5hZ) (time frame: 24 hours). 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 22 May 2023.