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

HIV Clinical Trial

— HIVOL2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667678
• Other study ID #: 1508032
• Secondary ID: 2015-001455-68
• Status: Completed
• Phase: Phase 4
• Start date: February 8, 2016
• Est. completion date: September 30, 2018

Study information

• Verified date: March 2019
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
France	Chu Saint Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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