NCT05869084

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

May 11, 2023

Last Update Submit

May 11, 2023

Conditions

HIV

Keywords

antiretrovirals

Outcome Measures

Primary Outcomes (1)

  • Resistance measured by forced oscillometry (5hZ)

    Resistance measured by forced oscillometry (5hZ)

    24 hours

Study Arms (1)

pulmonary function tests

EXPERIMENTAL
Diagnostic Test: pulmonary function tests

Interventions

pulmonary function testsDIAGNOSTIC_TEST

pulmonary function tests

pulmonary function tests

Eligibility Criteria

Age11 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children over 11 and Under 25-year-old infected with HIV and on antiretrovirals and followed up at Robert Debré hospital for this pathology

You may not qualify if:

  • Age ≤ 11 years old
  • Not treated for HIV
  • Patients under guardianship / curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

Location

MeSH Terms

Interventions

Respiratory Function Tests

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Veronique HOUDOUIN, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2023

First Posted

May 22, 2023

Study Start

March 1, 2022

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

May 22, 2023

Record last verified: 2023-05

Locations

FR(1)