Bone, Inflammation, Gut and Renal Biomarkers in Antiretro... | NCT03660722

Studies
Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects

NCT03660722

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Withdrawn

Last Update Posted

Nov 22, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

HIV Positive

Interventions

blood and urinary samples

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

ID	Type	Description	Link
2018-001358-84	EudraCT Number

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study not started

Expanded Access Info

Start Date

Oct 2023Estimated

Primary Completion Date

Oct 2023Estimated

Completion Date

Feb 2024Estimated

First Submitted Date

Sep 4, 2018

First Submission Date that Met QC Criteria

Sep 4, 2018

First Posted Date

Sep 6, 2018Actual

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

Nov 20, 2023

Last Update Posted Date

Nov 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Description Module

Brief Summary

Co-morbidities, including low bone mineral density, increased visceral adiposity and chronic kidney disease (CKD) are frequent in people living with HIV, and may be driven by ongoing inflammation and immune activation. Initiation of ART reduces inflammation and immune activation and is associated with changes in bone and renal biomarkers and gut microbiota. Investigators hypothesise that changes in gut microbiome when starting antiretroviral therapy correlate to changes in bone and renal biomarkers and wish to explore possible mechanisms linking these by investigating changes in markers of inflammation and immune activation.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Blood and urinary sample	Other	Blood and urinary sample in HIV 1 positive adults initiating treatment	Other: blood and urinary samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood and urinary samples	Other	blood samples, rectal and urethral swabs , urine samples at inclusion, after 4 weeks then 12 weeks	Blood and urinary sample

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
faecal microbial alpha-diversity	Change in faecal microbial alpha-diversity (change in mean Shannon Diversity Index score in faecal microbiota) .	At 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
markers of gut epithelium integrity	Change in markers of gut epithelium integrity and bacterial translocation	At 12 weeks
inflammatory marker	Change in inflammatory marker (c-reactive protein)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV-1 positive
Age 18-64 years
Able to give informed consent
Not previously treated for chronic HIV-1 infection, except for pre- or post- exposure prophylaxis exposure or treatment for mother to child transmission >12 months ago
Due to commence antiretroviral therapy by treating clinician

Exclusion Criteria:

- Previous major intestinal surgery/inflammatory bowel conditions
Infective diarrhoea in the last 3 months
BMI<18.5
Currently pregnant OR planning to conceive during the study period
Previous use of antiretroviral therapy, except for pre- or post- exposure prophylaxis exposure or treatment for mother to child transmission >12 months ago
Use of antibiotics (except for prophylactic co-trimoxazole) within the last 2 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amandine GAGNEUX-BRUNON, MD	Centre Hospitalier Universitaire de Saint Etienne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Saint-Etienne		Saint-Etienne			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
D006679	HIV Seropositivity

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
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided