Renal Function Assessment in HIV Patient

NCT00821847 | Completed DMC

• 1 other identifier: P080202
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; HIV Infections

Keywords

HIV; glomerular filtration rate; cockcroft; MDRD formula; creatinine; cystatin C; isotopic clearance; EDTA-51Cr; DEXA scan

Outcome Measures

Primary Outcomes (1)

• GFR estimated with Cockcroft and Gault and MDRD formulae and cystatin C dosage compared to isotopic evaluation of GFR

  within 10 weeks after inclusion

Secondary Outcomes (2)

• Variability of creatinine plasma dosage within two different methods

  during the study

• Role of bone density on validity of renal function markers in HIV patients

  during the study

Study Arms (1)

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

Interventions

DEXA scan OTHER

DEXA scan

1:experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• acute renal failure
• dysthyroidal function
• metallic prosthesis
• unable to understand the informed consent document
• venous puncture impossible
• receiving steroids
• no possible follow up

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Sidaction: collaborator

Study Sites (1)

Pitié Salpetriere Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; HIV Infections

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Corinne Isnard Bagnis, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: June 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: July 31, 2012

Record last verified: 2008-06

Locations

FR (1)