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

NCT03660722 | Withdrawn

• 2 other identifiers: 17082122018-001358-84
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

HIV Positive

Outcome Measures

Primary Outcomes (1)

• faecal microbial alpha-diversity

  Change in faecal microbial alpha-diversity (change in mean Shannon Diversity Index score in faecal microbiota) .

  At 12 weeks

Secondary Outcomes (5)

• markers of gut epithelium integrity

  At 12 weeks

• inflammatory marker

  at 12 weeks

• circulating markers of monocyte activation

  at 12 weeks

• renal glomerular biomarkers

  at 12 weeks

• bone biomarkers

  at 12 weeks

Study Arms (1)

Blood and urinary sample

OTHER

Blood and urinary sample in HIV 1 positive adults initiating treatment

Other: blood and urinary samples

Interventions

blood and urinary samples OTHER

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

Blood and urinary sample

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

HIV Seropositivity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Amandine GAGNEUX-BRUNON, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: October 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: February 1, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)