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

November 20, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne

Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects Commencing Antiretroviral Therapy: the BIGgeR Study.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

Study Contact Backup

Study Locations

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 to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

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

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Blood and urinary sample
Blood and urinary sample in HIV 1 positive adults initiating treatment
Other: blood and urinary samples
blood samples, rectal and urethral swabs , urine samples at inclusion, after 4 weeks then 12 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
markers of gut epithelium integrity
Time Frame: At 12 weeks
Change in markers of gut epithelium integrity and bacterial translocation
At 12 weeks
inflammatory marker
Time Frame: at 12 weeks
Change in inflammatory marker (c-reactive protein)
at 12 weeks
circulating markers of monocyte activation
Time Frame: at 12 weeks
Change in circulating marker of monocyte activation
at 12 weeks
renal glomerular biomarkers
Time Frame: at 12 weeks
Change in renal glomerular biomarker (KIM-1)
at 12 weeks
bone biomarkers
Time Frame: at 12 weeks
Change in bone biomarkers
at 12 weeks

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Amandine GAGNEUX-BRUNON, MD, CHU Saint-Etienne

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 (Estimated)

October 1, 2023

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

September 4, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1708212
  • 2018-001358-84 (EudraCT Number)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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