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Protocol Number:
07-DK-0212
- Title:
Prospective Evaluation of Albuminuria in HIV Positive Patients
- Number:
07-DK-0212
- Summary:
This study will examine the following: 1) how common albuminuria and proteinuria are among HIV-positive patients, 2) what causes albuminuria or proteinuria in these patients and 3) whether the condition becomes more severe over time. HIV-infected people are more likely than others to develop kidney disease. The earliest indicator of the possible presence of kidney disease is albuminuria (increased amounts of the protein albumin in the urine). A later indicator is the appearance of other proteins, a condition called proteinuria.
HIV-infected patients 8 years of age and older who do not have diabetes, chronic kidney disease or cancer may be eligible for this study.
Participants provide a urine sample during three visits as follows: the first upon enrollment in the study, a second 3 months later, and a third about 6 months after that. Blood samples are drawn at the first and last visits. At the first visit a medical history is taken and blood pressure, height, weight, waist circumference, hip circumference and upper arm skin thickness are measured.
Participants who are found to have albuminuria or proteinuria are asked to undergo a kidney biopsy for research purposes. The procedure is optional. Participants who develop heavy proteinuria may be recommended to undergo a kidney biopsy in order to determine the nature of the kidney disease and begin treatment. The biopsy requires a 2-day hospital stay. For the procedure, an anesthetic is given to numb the skin and a needle is inserted and guided into the kidney to withdraw a small tissue sample. The needle is passed twice, and possibly three times. Following the procedure, the subject remains in bed rest for at least 10 hours to minimize the risk of excessive bleeding.
- Sponsoring Institute:
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Recruitment Detail
- Type:
Participants currently recruited/enrolled
- Gender:
Male & Female
- Referral Letter Required:
No
- Population Exclusion(s):
None
- Eligibility Criteria:
INCLUSION CRITERIA:
-HIV+ adults and children greater than 8 years of age
EXCLUSION CRITERIA:
-Inability or unwillingness to give consent or assent
-Unable to return to NIH or Washington Hospital Center for two follow-up visits over a 9-month period
-New opportunistic infection within past 3 months or active opportunistic infection
-Active malignancy, other than non-melanoma skin cancer
-Diabetes by history
-IL-2 therapy within past 3 months
-Non compliance, -Alcohol use, and Drug use
-Diabetes (fasting glucose greater than 125 mg/dL or 2 hour oral glucose tolerance value greater than or equal to 200 mg/dL or current diagnosis of diabetes).
-Chronic kidney disease, defined as urine protein/creatinine ratio greater than 0.5 and sustained on at least 2 measurements.
-Pregnant Women
- Special Instructions:
Currently Not Provided
- Keywords:
-
Focal Segmental Glomerulosclerosis
-
Collapsing Glomerulopathy
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Anti-Retroviral Toxicity
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Lipodystrophy
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Metabolic Syndrome
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Tubular Injury
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Renal Biopsy
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Proteinuria
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Tenofovir Toxicity
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HAART Toxicity
- Recruitment Keyword(s):
-
HIV Positive
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HIV-Associated Focal Segmental Glomerulosclerosis
- Condition(s):
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HIV-Associated Focal Segmental Glomerulosclerosis
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HIV-Associated Collapsing Glomerulopathy
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Proteinuria
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Albuminuria
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Renal Tubular Toxicity
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Intervention(s):
- None
- Supporting Site:
- National Institute of Diabetes and Digestive and Kidney Diseases
- Contact(s):
-
Patient Recruitment and Public Liaison Office
Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 Electronic Mail:prpl@mail.cc.nih.gov
- Citation(s):
-
Han TM, Naicker S, Ramdial PK, Assounga AG. A cross-sectional study of HIV-seropositive patients with varying degrees of proteinuria in South Africa. Kidney Int, 2006. 69(12): p. 2243-50
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Jones CA, Francis ME, Eberhardt MS, Chavers B, Coresh J, Engelgau M, Kusek JW, Byrd-Holt D, Narayan KM, Herman WH, Jones CP, Salive M, Agodoa LY. Microalbuminuria in the US population: third National Health and Nutritional Examination Survey. Am J Kidney Dis, 2002. 39: p. 445-459
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Chavers BM, Bilous RW, Ellis EN, Steffes MW, Mauer SM. Glomerular lesions and urinary albumin excretion in type I diabetes without overt proteinuria. N Engl J Med, 1989. 320(15): p. 966-70.
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Bethesda, Maryland 20892. Last update: 09/20/2008
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