ResppedHIV: Assessment of Bronchial Obstruction in Adolescents With HIV

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT05869084

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV	Diagnostic Test: pulmonary function tests	N/A

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

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Assessment of Bronchial Obstruction in Adolescents With HIV

Actual Study Start Date :

Mar 1, 2022

Actual Primary Completion Date :

Jun 1, 2022

Actual Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pulmonary function tests	Diagnostic Test: pulmonary function tests pulmonary function tests

Arm

Intervention/Treatment

Experimental: pulmonary function tests

Diagnostic Test: pulmonary function tests

pulmonary function tests

Outcome Measures

Primary Outcome Measures

Resistance measured by forced oscillometry (5hZ) [24 hours]
Resistance measured by forced oscillometry (5hZ)

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Robert Debre Hospital	Paris		France	75019

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Veronique HOUDOUIN, PhD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT05869084

Other Study ID Numbers:

APHP211566
IDRCB: 2021-A02635-36

First Posted:

May 22, 2023

Last Update Posted:

May 22, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Assistance Publique - Hôpitaux de Paris

antiretrovirals

Study Results

No Results Posted as of May 22, 2023