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OpenTrials
Completed

NCT Number: NCT02522338

Measurement of Glomerular Filtration Rate (GFR) in HIV Patients: Single-center Study Comparing the Accuracy of Estimators of GFR Versus Iohexol Plasma Clearance

Cystatin C, a protease inhibitor produced by most nucleated cells, is freely filtered by the kidneys, and its plasma assay reflects the GFR.

Compare, in HIV patients, the predictive performance of 11 formula to estimate GFR based on assay plasma cystatin C with that of the MDRD formulas.

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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 de SAINT-ETIENNE

Saint-Etienne, 42000, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients infected with HIV, and included in the cohort NADIS

Exclusion criteria

  • Patient with a known allergy
  • Patients treated with metformin
  • Patients with severe hepatic impairment defined as a TP spontaneously below 50%
  • Patients with a history of dysthyroidism
  • Patient with active neoplasia other than skin cancer
  • Degradation recent (not older than 3 months) in renal function defined as the deterioration of GFR over 25%.
  • Estimated GFR less than 15 mL/min/1, 73m2
  • Pregnant or lactating
  • Subjects under the protection of justice

Treatment and study plan

Iohexol

Drug

10 ml de l'iohexol (300 mgI/ml)

Primary outcomes

  1. Patient with a predictive performance range -30% to +30%

    Time frame: day 0

    for each estimator :predictive performance calculated by [(DFG estimé* - DFG mesuré par iohexol**)/DFG mesuré par iohexol]X100

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: HIVOL

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 13, 2015
Registry last updated
Mar 10, 2016

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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