Evaluation of Albuminuria HIV-Infected Patients

NCT00524992 | Completed

• 2 other identifiers: 07021207-DK-0212
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HIV-Associated Focal Segmental Glomerulosclerosis; HIV-Associated Collapsing Glomerulopathy; Proteinuria; Albuminuria; Renal Tubular Toxicity

Keywords

Focal Segmental Glomerulosclerosis; Collapsing Glomerulopathy; Anti-Retroviral Toxicity; Lipodystrophy; Metabolic Syndrome; Tubular Injury; Renal Biopsy; Proteinuria; Tenofovir Toxicity; HAART Toxicity; HIV Positive; HIV-Associated Focal Segmental Glomerulosclerosis

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV+ adults and children greater than 8 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (2)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• 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 Jun;69(12):2243-50. doi: 10.1038/sj.ki.5000339. Epub 2006 May 3.

  PMID: 16672914 BACKGROUND

• 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 Nutrition Examination Survey. Am J Kidney Dis. 2002 Mar;39(3):445-59. doi: 10.1053/ajkd.2002.31388.

  PMID: 11877563 BACKGROUND

• 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 Apr 13;320(15):966-70. doi: 10.1056/NEJM198904133201503.

  PMID: 2784542 BACKGROUND

• Hadigan C, Edwards E, Rosenberg A, Purdy JB, Fleischman E, Howard L, Mican JM, Sampath K, Oyalowo A, Johnson A, Adler A, Rehm C, Smith M, Lai L, Kopp JB. Microalbuminuria in HIV disease. Am J Nephrol. 2013;37(5):443-51. doi: 10.1159/000350384. Epub 2013 Apr 20.

  PMID: 23615312 DERIVED

MeSH Terms

Conditions

Proteinuria; Albuminuria; Glomerulosclerosis, Focal Segmental; Lipodystrophy; Metabolic Syndrome; HIV Seropositivity

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glomerulonephritis; Nephritis; Kidney Diseases; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; HIV Infections; 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

Study Officials

• Jeffrey B Kopp, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2007
• First Posted: September 5, 2007
• Study Start: August 29, 2007
• Study Completion: December 24, 2014
• Last Updated: April 5, 2018

Record last verified: 2014-12-24

Locations

US (2)