Data collection in Hiv - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Hiv

Intervention / Treatment

Other: data collection

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Locations

France
- - Tourcoing, France
    - Recruiting
    - CH Tourcoing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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 Time Frame: At the end of the study an average of 18 months	At the end of the study an average of 18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients on immunosuppressive treatment, Time Frame: At the end of the study an average of 18 months	At the end of the study an average of 18 months
Occurrence of infectious complications Time Frame: At the end of the study an average of 18 months	At the end of the study an average of 18 months
Number of patients on remission Time Frame: At the end of the study an average of 18 months	At the end of the study an average of 18 months
Evolution of CD4 and HIV viral load Time Frame: At the end of the study an average of 18 months	At the end of the study an average of 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tourcoing Hospital

Investigators

Principal Investigator: Nathalie VIGET, MD, CH Tourcoing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)