HIV and Inflammatory or Autoimmune Disease: Rare Patients... | NCT05036811

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

NCT05036811

Sponsor

Tourcoing Hospital

Status

Unknown status

Last Update Posted

Sep 8, 2021Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Interventions

data collection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 7, 2021Actual

Primary Completion Date

Dec 2022Estimated

Completion Date

Mar 2023Estimated

First Submitted Date

Apr 16, 2021

First Submission Date that Met QC Criteria

Sep 6, 2021

First Posted Date

Sep 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2021

Last Update Posted Date

Sep 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Name	Type	Description	Arm Group Labels	Other Names
data collection	Other	data collection

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with HIV and an inflammatory or autoimmune disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nathalie VIGET, MD	Contact	0320694848		nviget@ch-tourcoing.fr
Solange TREHOUX, PhD	Contact	0320694280		strehoux@ch-tourcoing.fr

Overall Officials

Name	Affiliation	Role
Nathalie VIGET, MD	CH TOURCOING	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CH Tourcoing	Recruiting	Tourcoing			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided