HIV Positive
Conditions
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.
Interventions
OTHERblood and urinary samples
blood samples, rectal and urethral swabs , urine samples at inclusion, after 4 weeks then 12 weeks
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| faecal microbial alpha-diversity | At 12 weeks | Change in faecal microbial alpha-diversity (change in mean Shannon Diversity Index score in faecal microbiota) . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| renal glomerular biomarkers | at 12 weeks | Change in renal glomerular biomarker (KIM-1) |
| bone biomarkers | at 12 weeks | Change in bone biomarkers |
Countries
France
Outcome results
None listed