HIV and Inflammatory or Autoimmune Disease: Rare Patients, Many Questions (MAIVIH) (MAIVIH)

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

Study Overview

• Status: Recruiting
• Conditions: Hiv
• Intervention / Treatment: Other: data collection

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Nathalie VIGET, MD; Phone Number: 0320694848; Email: nviget@ch-tourcoing.fr

Study Locations

• France
  • Tourcoing, France
    • Recruiting
    • CH Tourcoing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with HIV and an inflammatory or autoimmune disease

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Tourcoing Hospital
• Investigators: Principal Investigator: Nathalie VIGET, MD, CH Tourcoing

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: September 6, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: NRIPH_2020_11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No