5 Years Follow-up Evaluation of Deterioration Kidney Biomarkers of HIV Patients (HIVOL2)

5 Years Follow-up Evaluation of Deterioration Kidney Biomarkers of HIV Patients : HIVOL 2 Study.

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Biological: Cohort HIVOL, patients infected by HIV

Detailed Description

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.

From 2011 to 2013, researchers realized a study called HIVOL, on the diagnostic performance of GFR (Glomerular Filtration Rate) estimators in patients infected with HIV. It lead to a publication in AIDS, retaken in the rational of recommendations of Infectious Diseases Society of America for the Chronic Renal Diseases support for patients infected with HIV.

235 patients were involved, for everyone researchers have a GFR measure (by Iohexol plasmatic clearance) and urinary and plasma samples.

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42100
    • Chu Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort HIVOL, patients infected by HIV; 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; 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.; Other Names: Blood and urinary samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: GAGNEUX-BRUNON Amandine, MD, Chu Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2016
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): April 1, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1508032; 2015-001455-68 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No