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

Phase 4

Completed

• Conditions: HIV
• Interventions: Biological: Cohort HIVOL, patients infected by HIV

• Registration Number: NCT02667678
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

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 Timeline

• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Study Start: 2016-02-08
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort HIVOL, patients infected by HIV	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.

Primary Outcome Measures

Name	Time	Method
Stage of chronic kidney disease (according to the Glomerular Filtration Rate)	Day 1	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.

Trial Locations

Locations (1)

Chu Saint Etienne; 🇫🇷 Saint-etienne, France