Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 positive subjects commencing Antiretroviral Therapy

Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 positive subjects commencing Antiretroviral Therapy - BIGgeR

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001358-84-FR

Enrollment

Registered

2018-04-03

Start date

2018-10-12

Completion date

Unknown

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-positive subjects initiating antiretroviral therapy MedDRA version: 20.1 Level: LLT Classification code 10020160 Term: HIV disease System Organ Class: 100000004862

Interventions

Product Name: rilpivirine Pharmaceutical Form: Tablet Product Name: emtricitabine Pharmaceutical Form: Capsule Product Name: raltégravir Pharmaceutical Form: Coated tablet Product Name: lamivudine

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Previous major intestinal surgery/inflammatory bowel conditions - Infective diarrhoea in the last 3 months - BMI12 months ago - Use of antibiotics (except for prophylactic co-trimoxazole) within the last 2 months

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine if there is an association between change in faecal microbiota and antiretroviral initiation as characterised by change in alpha-diversity evaluated by Shannon Diversity Index.;Secondary Objective: Change in faecal microbiota correlate with change in : - markers of gut epithelial dysfunction and bacterial translocation - inflammatory marker: c-reactive protein - monocyte activation markers - bone turnover markers - renal (glomerular) biomarkers - liver stiffness measurement - bone mineral density at lumbar spine and femoral neck;Primary end point(s): Change in faecal microbial alpha-diversity (change in mean Shannon Diversity Index score in faecal microbiota) from baseline to 12 weeks;Timepoint(s) of evaluation of this end point: 12 weeks	—

Measure

Time frame

Main Objective: To determine if there is an association between change in faecal microbiota and antiretroviral initiation as characterised by change in alpha-diversity evaluated by Shannon Diversity Index.;Secondary Objective: Change in faecal microbiota correlate with change in : - markers of gut epithelial dysfunction and bacterial translocation - inflammatory marker: c-reactive protein - monocyte activation markers - bone turnover markers - renal (glomerular) biomarkers - liver stiffness measurement - bone mineral density at lumbar spine and femoral neck;Primary end point(s): Change in faecal microbial alpha-diversity (change in mean Shannon Diversity Index score in faecal microbiota) from baseline to 12 weeks;Timepoint(s) of evaluation of this end point: 12 weeks

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Secondary

Measure	Time frame
Secondary end point(s): • Change in markers of gut epithelium integrity and bacterial translocation (e.g. FABP) • Change in inflammatory marker (c-reactive protein) at 12 weeks • Change in circulating markers of monocyte activation (e.g. sCD14, sCD163) • Change in renal glomerular biomarkers at 12 weeks (e.g. KIM-1/ alpha-1 microglobulin, NAG) • Change in bone biomarkers at 12 weeks (OC, P1NP, CTX);Timepoint(s) of evaluation of this end point: 12 weeks	—

Measure

Time frame

Secondary end point(s): • Change in markers of gut epithelium integrity and bacterial translocation (e.g. FABP) • Change in inflammatory marker (c-reactive protein) at 12 weeks • Change in circulating markers of monocyte activation (e.g. sCD14, sCD163) • Change in renal glomerular biomarkers at 12 weeks (e.g. KIM-1/ alpha-1 microglobulin, NAG) • Change in bone biomarkers at 12 weeks (OC, P1NP, CTX);Timepoint(s) of evaluation of this end point: 12 weeks

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Countries

France

Contacts

Public ContactProject manager

CHU de Saint Etienne

marie.peuriere@chu-st-etienne.fr0477829272+33

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026