CClinicalTrials.gg
CompletedNCT05869084ResppedHIVUpdated May 22, 2023

Assessment of Bronchial Obstruction in Adolescents With HIV

An interventional study of pulmonary function tests in HIV, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 11 Years to 25 Years. Per ClinicalTrials.gov, last updated 2023-05-22.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Mar 2022, registered May 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
11 Years to 25 Years
Sex
All
01

Study 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.

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

02

Conditions studied

  • HIV

Keywords

  • antiretrovirals
03

In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    pulmonary function tests

    Diagnostic Test: pulmonary function tests

Interventions

  • Diagnostic testpulmonary function tests

    pulmonary function tests

06

What researchers measure

Primary outcomes

  1. Resistance measured by forced oscillometry (5hZ)

    Resistance measured by forced oscillometry (5hZ)

    Time frame: 24 hours

07

Study locations

1 site
  • Robert Debre Hospital
    Paris, 75019, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05869084
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
May 22, 2023
Start date
Mar 1, 2022
Primary completion
Jun 1, 2022
Completion
Jul 1, 2022
Last update
May 22, 2023

Study contacts

Veronique HOUDOUIN, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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