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Renal Function Assessment in HIV Patient (HIVERS)

This study has been completed.
Sponsor:
Collaborator:
Sidaction
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00821847
First received: January 13, 2009
Last updated: July 30, 2012
Last verified: June 2008
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Variability of creatinine plasma dosage within two different methods [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • Role of bone density on validity of renal function markers in HIV patients [ Time Frame: during the study ] [ Designated as safety issue: No ]

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
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
Other Name: DEXA scan

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

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
Acquired Immunodeficiency Syndrome
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on June 18, 2013