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Completed

NCT Number: NCT02667678

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

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chu Saint Etienne

Saint-Etienne, 42100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cohort HIVOL, patients infected by HIV

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.

Other names: Blood and urinary samples

Primary outcomes

  1. Stage of chronic kidney disease (according to the Glomerular Filtration Rate)

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: HIVOL2

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2016
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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