NCT05036811

Brief Summary

Follow-up registry of patients living with HIV who also have various inflammatory and autoimmune pathologies that may require immunosuppressive treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 16, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 7, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

September 8, 2021

Status Verified

April 1, 2021

Enrollment Period

1.5 years

First QC Date

April 16, 2021

Last Update Submit

September 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients living with HIV who have an inflammatory or autoimmune disease

    At the end of the study an average of 18 months

Secondary Outcomes (4)

  • Number of patients on immunosuppressive treatment,

    At the end of the study an average of 18 months

  • Occurrence of infectious complications

    At the end of the study an average of 18 months

  • Number of patients on remission

    At the end of the study an average of 18 months

  • Evolution of CD4 and HIV viral load

    At the end of the study an average of 18 months

Interventions

data collection

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with HIV and an inflammatory or autoimmune disease

You may qualify if:

  • Patient living with HIV
  • Carrier of one or more of the following diseases:
  • Sarcoidosis Multiple sclerosis Myasthenia gravis Crohn's disease Hemorrhagic rectocolitis Autoimmune hepatitis Arthropathic psoriasis Still's disease, other rheumatoid arthritides, juvenile polyarthritides, Rheumatoid arthritis Vasculitides: periarteritis nodosa and related conditions, other necrotizing vasculopathies (periarteritis nodosa, juvenile periarteritis, Churg-Strauss disease, polyangiitis, Kawasaki disease, Horton's disease, Wegener's disease, thrombotic microangiopathy, Takayashu syndrome, Good-Pasture's syndrome, thrombocytopenic purpura) Lupus Polymyositis or dermatopolymyositis Connectivitis (Behcet's disease, Gougerot-Sjöogren syndrome) Inflammatory spondyloarthropathies (APS, spondyloarthritis, other spondyloarthropathies)

You may not qualify if:

  • Opposition of the person
  • Minor patients
  • Patients under judicial protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH Tourcoing

Tourcoing, France

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Data Collection

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Nathalie VIGET, MD

    CH TOURCOING

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie VIGET, MD

CONTACT

Solange TREHOUX, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2021

First Posted

September 8, 2021

Study Start

June 7, 2021

Primary Completion

December 1, 2022

Study Completion

March 1, 2023

Last Updated

September 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations