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

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Completed; Phase 4

Conditions: HIV

Treatments: Biological: Cohort HIVOL, patients infected by HIV

Study type: Interventional

Funder types: Other

Identifiers

NCT02667678

2015-001455-68 (EudraCT Number)

1508032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 173 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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173 participants in 1 patient group

Cohort HIVOL, patients infected by HIV

Experimental group

Description:

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.

Treatment:

Biological: Cohort HIVOL, patients infected by HIV