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Renal Function Assessment in HIV Patient (HIVERS)

This study has been completed.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: January 13, 2009
Last updated: July 30, 2012
Last verified: June 2008

Recent progress in antiretroviral therapy has turned HIV infection into a chronic disease. Patients survival has dramatically improved but complications may occur that need to be prevented and monitored. As much as 10 % of HIV patients may suffer from chronic kidney disease, an affection that is not symptomatic until a very late stage secondary to HIV infection, drugs exposure, hypertension or diabetes. Guidelines have suggested that renal function should be regularly assessed in HIV patients to perform early diagnosis for chronic kidney disease and allow initiation of preventive measures aimed at preserving renal function.

Plasma creatinine dosage is the easiest way to evaluate renal function but glomerular filtration rate estimation from cockcroft or MDRD formulae is a much better indicator of renal function. Other markers like cystatin C may be used. None of these markers has been validated in HIV patients. Therefore our study is aimed at comparing validity of creatinine clearance estimation with Cockcroft and Gault and MDRD formula and cystatin C compared to the gold standard measurement of glomerular renal function.

Condition Intervention
Chronic Kidney Disease
HIV Infections
Other: DEXA scan

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Markers of Glomerular Filtration Rate in the HIV Infected Patient - Role of Body Composition

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • GFR estimated with Cockcroft and Gault and MDRD formulae and cystatin C dosage compared to isotopic evaluation of GFR [ Time Frame: within 10 weeks after inclusion ]

Secondary Outcome Measures:
  • Variability of creatinine plasma dosage within two different methods [ Time Frame: during the study ]
  • Role of bone density on validity of renal function markers in HIV patients [ Time Frame: during the study ]

Enrollment: 45
Study Start Date: June 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
male, caucasian, HIV infected patients with glomerular filtration rate between 60 and 30 ml/min (estimated with cockcroft and Gault formulae)
Other: DEXA scan
DEXA scan

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
male, caucasian, HIV infected patients with glomerular filtration rate between 60 and 30 ml/min (estimated with cockcroft and Gault formulae)

Inclusion criteria :

  • 18 Years and older
  • Patients must have detectable HIV-1 by western-blot consent signature
  • Estimated glomerular filtration rate, by Modification of Diet in Renal Disease (MDRD) or Cockcroft equation, between 30 and 60 ml/min/1.73m2
  • Male
  • Caucasian
  • Patient provides informed consent
  • Patient able to respect the protocol
  • social security affiliation

Exclusion criteria :

  • acute renal failure
  • dysthyroidal function
  • metallic prosthesis
  • unable to understand the informed consent document
  • venous puncture impossible
  • receiving steroids
  • no possible follow up
  Contacts and Locations
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Please refer to this study by its identifier: NCT00821847

Pitié Salpetriere Hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Corinne Isnard Bagnis, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00821847     History of Changes
Other Study ID Numbers: P080202
Study First Received: January 13, 2009
Last Updated: July 30, 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris:
glomerular filtration rate
MDRD formula
cystatin C
isotopic clearance
DEXA scan

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
HIV Infections
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases processed this record on May 25, 2017