Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects
NCT03660722 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2023-11-22
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.
Conditions
- HIV Positive
Interventions
- OTHER
-
blood and urinary samples
blood samples, rectal and urethral swabs , urine samples at inclusion, after 4 weeks then 12 weeks
Sponsors & Collaborators
-
Centre Hospitalier Universitaire de Saint Etienne
lead OTHER
Principal Investigators
-
Amandine GAGNEUX-BRUNON, MD · CHU SAINT-ETIENNE
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-31
- Primary Completion
- 2023-10-31
- Completion
- 2024-02-29
Countries
- France
Study Locations
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