5 Years Follow-up Evaluation of Deterioration Kidney Biomarkers of HIV Patients

NCT02667678 | Completed Phase 4

• 2 other identifiers: 15080322015-001455-68
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the biomarkers levels as IL-18, KIM-1 and Cystatin C for patients infected by HIV with failure in renal function at year 5. The main criterion will be a degradation of the glomerular filtration throughput measured. It will be compared to clinical scores of degradation risks of renal function for patients infected with HIV.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Stage of chronic kidney disease (according to the Glomerular Filtration Rate)

  The aim of this study is to compare the level of biological biomarkers as microalbuminuria, proteinuria, KIM-1, IL-18, and Cystatin C with the level of this markers 5 years ago, for the HIVOL study performed between 2011 and 2013. These levels will allow the researchers to have an idea concerning the renal function of the patients followed.

  Day 1

Study Arms (1)

Cohort HIVOL, patients infected by HIV

EXPERIMENTAL

Patients enrolled in HIVOL cohort (study performed between 2011 and 2013) will be contacted to participate to HIVOL-2. The intervention will be blood and urinary samples, with the use of iohexol (Omnipaque®) to have an idea on renal plasmatic clearance.

Biological: Cohort HIVOL, patients infected by HIV

Interventions

Cohort HIVOL, patients infected by HIV BIOLOGICAL

Researchers will take blood and urinary samples from the patients of the HIVOL cohort, to look at the renal clearance. The aim of this study is to check the renal function of the patients infected by HIV.

Also known as: Blood and urinary samples

Cohort HIVOL, patients infected by HIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient affiliated or entitled to a social security scheme
• Patient HIV infected
• Patient included in the HIVOL cohort with a GFR measure available
• Patients who have given their consent in writing

You may not qualify if:

• Pregnant or lactating women
• Patients treated with metformin
• Patients with a known allergy, regardless the type of allergy
• Patients with a history of thyroid dysfunction
• Any biological anomaly in the selection, which in the opinion of the investigator, may indicate a contraindication to the patient's participation in this study
• Degradation recent (not older than three months) of renal function defined as the degradation of more than 25 % GFR.
• Estimated GFR of less than 15 mL / min / 1.73m2
• History of major immediate or delayed skin reaction known to the injection of iodinated contrast medium (OMNIPAQUE®)
• Manifest thyrotoxicosis
• Hypersensitivity to the active substance or to any of the excipients (OMNIPAQUE®)
• Patient who expressed his refusal to participate in the study
• Patient justice under protection

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint Etienne

Saint-Etienne, 42100, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

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

Study Officials

• GAGNEUX-BRUNON Amandine, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: January 29, 2016
• Study Start: February 8, 2016
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: April 1, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)