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

NCT ID: NCT02667678

Last Updated: 2019-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-08
• Study Completion Date: 2018-09-30

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.

Conditions

HIV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cohort HIVOL, patients infected by HIV

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Blood and urinary samples

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GAGNEUX-BRUNON Amandine, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Chu Saint Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2015-001455-68

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1508032

Identifier Type: -

Identifier Source: org_study_id