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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05869084
Other study ID # APHP211566
Secondary ID IDRCB: 2021-A026
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date July 1, 2022

Study information

Verified date May 2023
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Screening for early peripheral obstruction could therefore make it possible to initiate appropriate anti-inflammatory treatment, if necessary, and early preventive management.


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


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date July 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 11 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
pulmonary function tests
pulmonary function tests

Locations

Country Name City State
France Robert Debre Hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resistance measured by forced oscillometry (5hZ) Resistance measured by forced oscillometry (5hZ) 24 hours
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