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

Phase 1

Conditions: HIV-positive subjects initiating antiretroviral therapy
MedDRA version: 20.1Level: LLTClassification code 10020160Term: HIV diseaseSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2018-001358-84-FR

Lead Sponsor: CHU de Saint Etienne

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 50

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

-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

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 :<br>-markers of gut epithelial dysfunction and bacterial translocation<br>-inflammatory marker: c-reactive protein<br>-monocyte activation markers<br>-bone turnover markers<br>-renal (glomerular) biomarkers<br>-liver stiffness measurement<br>-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

Secondary Outcome Measures

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