search
Back to results

Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects (BIGGER)

Primary Purpose

HIV Positive

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood and urinary samples
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HIV Positive

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Saint-Etienne

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Blood and urinary sample

Arm Description

Blood and urinary sample in HIV 1 positive adults initiating treatment

Outcomes

Primary Outcome Measures

faecal microbial alpha-diversity
Change in faecal microbial alpha-diversity (change in mean Shannon Diversity Index score in faecal microbiota) .

Secondary Outcome Measures

markers of gut epithelium integrity
Change in markers of gut epithelium integrity and bacterial translocation
inflammatory marker
Change in inflammatory marker (c-reactive protein)
circulating markers of monocyte activation
Change in circulating marker of monocyte activation
renal glomerular biomarkers
Change in renal glomerular biomarker (KIM-1)
bone biomarkers
Change in bone biomarkers

Full Information

First Posted
September 4, 2018
Last Updated
June 2, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
search

1. Study Identification

Unique Protocol Identification Number
NCT03660722
Brief Title
Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects
Acronym
BIGGER
Official Title
Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects Commencing Antiretroviral Therapy: the BIGgeR Study.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Positive

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blood and urinary sample
Arm Type
Other
Arm Description
Blood and urinary sample in HIV 1 positive adults initiating treatment
Intervention Type
Other
Intervention Name(s)
blood and urinary samples
Intervention Description
blood samples, rectal and urethral swabs , urine samples at inclusion, after 4 weeks then 12 weeks
Primary Outcome Measure Information:
Title
faecal microbial alpha-diversity
Description
Change in faecal microbial alpha-diversity (change in mean Shannon Diversity Index score in faecal microbiota) .
Time Frame
At 12 weeks
Secondary Outcome Measure Information:
Title
markers of gut epithelium integrity
Description
Change in markers of gut epithelium integrity and bacterial translocation
Time Frame
At 12 weeks
Title
inflammatory marker
Description
Change in inflammatory marker (c-reactive protein)
Time Frame
at 12 weeks
Title
circulating markers of monocyte activation
Description
Change in circulating marker of monocyte activation
Time Frame
at 12 weeks
Title
renal glomerular biomarkers
Description
Change in renal glomerular biomarker (KIM-1)
Time Frame
at 12 weeks
Title
bone biomarkers
Description
Change in bone biomarkers
Time Frame
at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carine LABRUYERE, CRA
Phone
0477120764
Email
carine.labruyere@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Amandine GAGNEUX-BRUNON, MD
Phone
0477120764
Email
Amandine.Gagneux-Brunon@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amandine GAGNEUX-BRUNON, MD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
Saint-etienne
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amandine GAGNEUX-BRUNON, MD
Email
Amandine.Gagneux-Brunon@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Amandine GAGNEUX-BRUNON, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs