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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03660722
Other study ID # 1708212
Secondary ID 2018-001358-84
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2023
Est. completion date February 2024

Study information

Verified date November 2023
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 2024
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Chu Saint-Etienne Saint-etienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary faecal microbial alpha-diversity Change in faecal microbial alpha-diversity (change in mean Shannon Diversity Index score in faecal microbiota) . At 12 weeks
Secondary markers of gut epithelium integrity Change in markers of gut epithelium integrity and bacterial translocation At 12 weeks
Secondary inflammatory marker Change in inflammatory marker (c-reactive protein) at 12 weeks
Secondary circulating markers of monocyte activation Change in circulating marker of monocyte activation at 12 weeks
Secondary renal glomerular biomarkers Change in renal glomerular biomarker (KIM-1) at 12 weeks
Secondary bone biomarkers Change in bone biomarkers at 12 weeks
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