Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects Commencing Antiretroviral Therapy: the BIGgeR Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV Positive
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Locations
- 1
- Primary Endpoint
- faecal microbial alpha-diversity
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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) .
Secondary Outcomes
- renal glomerular biomarkers(at 12 weeks)
- bone biomarkers(at 12 weeks)
- markers of gut epithelium integrity(At 12 weeks)
- inflammatory marker(at 12 weeks)
- circulating markers of monocyte activation(at 12 weeks)