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

Not Applicable

Withdrawn

• Conditions: HIV Positive
• Interventions: Other: blood and urinary samples

• Registration Number: NCT03660722
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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 available

Study Timeline

• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-06
• Study Start: 2023-10
• Primary Completion: 2023-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood and urinary sample	blood and urinary samples	Blood and urinary sample in HIV 1 positive adults initiating treatment

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-etienne, France