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:

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 or to comply with study requirements

-Unable to return to NIH or Washington Hospital Center for two follow-up visits over a 9-month period

-New opportunistic or bacterial infection within past 3 months or active opportunistic infection.

-Active malignancy, other than non-melanoma skin cancer and cutaneous Kaposi sarcoma not requiring treatment. Rationale: systemic inflammation may induce microalbuminuria.

-Diabetes by history

-IL-2, IL-7 or IFN-alpha therapy within past 3 months. Rationale: IL-2 and IFN-alpha therapy induce renal dysfunction and IL-7 may be associated with systemic inflammation.

-Non compliance, alcohol use, and drug use are conditions that make study completion unlikely or difficult.

-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).

-Serum creatinine greater than 1.4 mg/dL.

-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

Anti-Retroviral Toxicity

Lipodystrophy

Metabolic Syndrome

Tubular Injury

Renal Biopsy

Proteinuria

Tenofovir Toxicity

HAART Toxicity

Recruitment Keyword(s):

HIV Positive

HIV-Associated Focal Segmental Glomerulosclerosis

Condition(s):

HIV-Associated Focal Segmental Glomerulosclerosis

HIV-Associated Collapsing Glomerulopathy

Proteinuria

Albuminuria

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

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

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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