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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02667678
Acronym
HIVOL2
Enrollment
173
Registered
2016-01-29
Start date
2016-02-08
Completion date
2018-09-30
Last updated
2019-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

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.

Interventions

BIOLOGICALCohort 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.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stage of chronic kidney disease (according to the Glomerular Filtration Rate)Day 1The 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026