Trials / Withdrawn
WithdrawnNCT03660722
Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects
Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects Commencing Antiretroviral Therapy: the BIGgeR Study.
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | blood and urinary samples | blood samples, rectal and urethral swabs , urine samples at inclusion, after 4 weeks then 12 weeks |
Timeline
- Start date
- 2023-10-01
- Primary completion
- 2023-10-01
- Completion
- 2024-02-01
- First posted
- 2018-09-06
- Last updated
- 2023-11-22
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03660722. Inclusion in this directory is not an endorsement.