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Renal Function Assessment in HIV Patient (HIVERS)

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ClinicalTrials.gov Identifier: NCT00821847
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : July 31, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Chronic Kidney Disease HIV Infections Other: DEXA scan

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Study Design

Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Markers of Glomerular Filtration Rate in the HIV Infected Patient - Role of Body Composition
Study Start Date : June 2009
Primary Completion Date : March 2012
Study Completion Date : March 2012

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
1:experimental
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Variability of creatinine plasma dosage within two different methods [ Time Frame: during the study ]
  2. Role of bone density on validity of renal function markers in HIV patients [ Time Frame: during the study ]

Eligibility Criteria

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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)
Criteria

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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821847


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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00821847     History of Changes
Other Study ID Numbers: P080202
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: June 2008

Keywords provided by Assistance Publique - Hôpitaux de Paris:
HIV
glomerular filtration rate
cockcroft
MDRD formula
creatinine
cystatin C
isotopic clearance
EDTA-51Cr
DEXA scan

Additional relevant MeSH terms:
HIV Infections
Kidney Diseases
Renal Insufficiency, Chronic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Urologic Diseases
Renal Insufficiency