Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects

HIV Positive Clinical Trial

— BIGGER  

Official title:

Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects Commencing Antiretroviral Therapy: the BIGgeR Study.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03660722
• Other study ID #: 1708212
• Secondary ID: 2018-001358-84
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• HIV Positive
• HIV Seropositivity
• Inflammation

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