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

Centre Hospitalier Universitaire de Saint Etienne

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

HIV Positive

Interventions

blood and urinary samplesOTHER

blood samples, rectal and urethral swabs , urine samples at inclusion, after 4 weeks then 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

Chu Saint-Etienne

Saint-Etienne, France

Outcomes

Primary Outcomes

faecal microbial alpha-diversity

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

Time frame: At 12 weeks

Secondary Outcomes

markers of gut epithelium integrity

Change in markers of gut epithelium integrity and bacterial translocation

Time frame: At 12 weeks

inflammatory marker

Change in inflammatory marker (c-reactive protein)

Time frame: at 12 weeks

circulating markers of monocyte activation

Change in circulating marker of monocyte activation

Time frame: at 12 weeks

renal glomerular biomarkers

Change in renal glomerular biomarker (KIM-1)

Time frame: at 12 weeks

bone biomarkers

Change in bone biomarkers

Time frame: at 12 weeks

Data from ClinicalTrials.gov

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