Clinical trial NCT02667678: 5 Years Follow-up Evaluation of Deterioration Kidney Biomarkers of HIV Patients
Official title: 5 Years Follow-up Evaluation of Deterioration Kidney Biomarkers of HIV Patients : HIVOL 2 Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Stage of chronic kidney disease (according to the Glomerular Filtration Rate)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: Chu Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: GAGNEUX-BRUNON Amandine, MD
role: PRINCIPAL_INVESTIGATOR
References: