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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
  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:


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

  Hide Detailed Description

Detailed Description:

Aim of the study :

The aim of our study is to test the different available markers for the estimation of glomerular filtration rate (GFR) in HIV patients in order to determine which one is the more appropriated in this particular population. We will analyze the role of the variation in muscular mass in the estimation of GFR

Background :

Several lines of evidence point to renal disease becoming an important complication of human immunodeficiency virus infection and therapy. The spectrum of renal disease in the HIV patient has dramatically changed with HIV associated nephropathy becoming less prevalent and chronic kidney disease [CKD] becoming an everyday concern parallel to the prevalence of renal risk factors such as aging, hypertension and diabetes. Different studies have shown that the prevalence of CKD defined as an estimated glomerular filtration rate below 60 ml/min/1.73m2 is around 10% in HIV patients. CKD is associated with increased mortality, a new concept that has emerged in the past years putting CKD in the top 5 critical cardiovascular risk factors. Evaluating individual renal function in HIV patients allows better care in prevention of cardiovascular events as well as initiation of nephro-protection strategies in order to slow down the loss of renal function and alleviate or postpone the need for dialysis. Since HIV patients also receive chronic multi-therapy, evaluating renal function is also mandatory to allow drug dosage adaptation.

Plasma creatinine dosage is routinely used to estimate GFR but it is closely correlated to age, sex, weight and ethnic origin of the patients. All these factors make creatinine unreliable for GFR estimation. Laboratory dosage of creatinine may be performed with different techniques (JAFFE or enzymatic dosage) with a 20% variation in the results for the same patient. None of the GFR estimation formulae (Cockcroft et Gault or MDRD) have been validated in HIV patients. Cystatin C, a new marker still under evaluation, seems to show some interest in such patients because of its relative independency with regard to muscle mass, but has not been tested in HIV patients. Some cystatin C based formulae have been proposed but not yet tested and validated in HIV patients. HIV infected patients may exhibit abnormal body composition particularly affecting lipids but also, as shown recently, muscle mass. Our study will precisely measure body composition in order to allow interpretation of the variations of the renal markers with regard to muscle mass.

METHODS :

60 patients (men, caucasians) with an estimated GFR between 60 and 15 ml/min/1.73m2 will be included in the study. After giving all necessary information and collection of informed consent, blood will be drown to allow creatinine, cystatin C, albumin, C reactive protein and urea dosages. GFR will be measured using plasmatic clearance of EDTA-51Cr. Body composition will be performed using DEXA scan. Two visits will be necessary to complete the evaluation for every patient, scheduled at the same time than the routine medical visits.

Expected results :

Our study should allow better definition of the ideal marker for GFR in HIV infected male. Il will also afford better comprehension of the factors involved in the variation of creatinine dosage in this population namely those related to the biochemical dosage and to the change in body composition.

Conclusion :

HIV infection and its treatment is definitely a serious risk factor for renal disease. Although, optimal care for HIV-infected patients becomes more and more complex due to multiple comorbidities, efforts must be made to diagnose a decline in glomerular filtration rate in order to provide improved control of CKD-associated cardiovascular risk and optimized antiretroviral therapy. Therefore evaluating glomerular filtration rate is critical in HIV-infected patients to allow determination of the optimum follow up strategy and the critical therapeutic measures, namely drug dosage adaptation.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 19, 2014