Prevalence of Proteinuria and Chronic Kidney Disease in Pediatric HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
Children's Research Institute
ClinicalTrials.gov Identifier:
NCT00153621
First received: September 8, 2005
Last updated: May 2, 2008
Last verified: September 2005
  Purpose

Among adults with Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome (AIDS), Chronic Kidney Disease (CKD) has previously been reported to occur in approximately 10% of children with HIV-infection. The frequency of CKD, its causes, and its natural history in children and adolescents with HIV-infection have not been systematically studied, particularly in the era of new anti-retroviral medications. The primary aim of this study is to determine the how common pediatric HIV-infected individuals have evidence of persistent proteinuria and CKD.


Condition
Chronic Kidney Failure
AIDS-Associated Nephropathy
HIV Infections

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prevalence of Proteinuria and Chronic Kidney Disease in Pediatric Patients in the Special Immunology, Burgess, and Nephrology Clinics

Resource links provided by NLM:


Further study details as provided by Children's Research Institute:

Estimated Enrollment: 320
Study Start Date: September 2004
Study Completion Date: September 2007
  Hide Detailed Description

Detailed Description:

Human Immunodeficiency Virus-infection has been a significant cause of pediatric morbidity and mortality since it was first identified in the early 1980s. In 1997, HIV became the fourth leading cause of death among children 1 to 4 years of age. As of December 2001, there were 9,074 children under the age of 13 years who have been diagnosed with AIDS in the United States and its territories, and an additional 3,923 children with HIV-infection under the age of 13 years. Human Immunodeficiency Virus-infection and AIDS do not affect children equally in the United States. Whereas whites comprise 61% of the pediatric population, they represent only 15-20% of children with HIV or AIDS. In contrast, African-Americans account for only 14% of the US pediatric population, but they represent 60-65% of children with HIV or AIDS. The prevalence rate of AIDS among African-American children in 2001 was 14 times greater than among white children, and 7 times higher than among Hispanic children.

A variety of renal, electrolyte, and acid-base disturbances have been described in patients with HIV-infection. These abnormalities may be associated with the HIV-infection itself, opportunistic infections, antiviral medications, or unrelated primary disorders. Proteinuria may serve as an early indicator of HIV-associated nephropathy (HIVAN), the pathologic renal lesions associated with HIV-infection itself. Autopsy data in adults with HIV-infection or AIDS have demonstrated a prevalence of HIVAN of between 1 and 15%. The prevalence of HIVAN in the pediatric population has been reported between 7 and 15%. The racial disparity seen in the AIDS population has also been described in the pediatric HIVAN population. Reports of HIVAN in pediatric populations found that 137 of 155 children (89%) in Miami, Florida and 208 of 217 children (96%) in Washington, DC were African-American.

The medical progress made in the treatment of HIV infection with highly active antiretroviral therapies (HAART) has led to a dramatic decline in the incidence of death among adults with HIV-infection. By 1999, however, HIV became the third leading cause of end-stage renal disease (ESRD) among African-Americans aged 20 to 64 years. In contrast to the declining incidence of HIV-infection in the adult population, the incidence of ESRD due to HIVAN has decreased much slower for unknown reasons. The incidence of pediatric AIDS cases also has been declining over the past decade, from 952 new cases diagnosed in 1992 to only 101 in 2001. The impact of the declining incidence of pediatric AIDS cases upon the incidence of pediatric HIVAN remains unknown. The progression of pediatric HIVAN appears to occur more slowly than the adult HIVAN population, with a mean time from initial diagnosis of HIVAN to ESRD of 8 to 20 months. Mortality is high in the pediatric HIV-infected population, with nearly 80% of pediatric patients with HIVAN dying.

For this study, we seek to estimate the prevalence of CKD in HIV-infected patients overall and within specific racial groups.

Participants will be screened with a first-morning macroscopic urinalysis for the detection of proteinuria, and a semi-quantitative measurement of proteinuria using urine protein-to-creatinine and urine microalbumin-to-creatinine ratios. Those patients who have proteinuria of greater than or equal to 1+ on a first-morning macrourinalysis, or a urine protein-to-creatinine ratio of > 0.20 or a urine microalbumin-to-creatinine ratio of > 30 mcg/mg of creatinine, will have a repeat first-morning macroscopic urinalysis, and urine protein-to-creatinine and urine microalbumin-to-creatinine ratios performed 3 months later. Prior to the obtaining of any of the urine samples, those participants who are taking angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) therapy for their anti-proteinuric or anti-hypertensive effects will discontinue their medication for 2 weeks prior to the urine sample collection. After collecting the first-morning urine sample, the study participant may resume his/her prior ACEI or ARB at the previously prescribed dose and schedule. Those patients who have fixed proteinuria on a first-morning macroscopic urinalysis on 2 occasions separated by 3 months will be referred to the Pediatric Nephrology Clinic for further evaluation for proteinuria and/or CKD. The calculated GFR will be determined using the most recent serum creatinine and patient height from the medical record using the Schwartz formula. Chronic Kidney Disease will be defined, as in the NKF KDOQI guidelines.

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Known/confirmed HIV-infection or AIDS
  • Age > 1 but < 21 years of age
  • Able to tolerate discontinuation of ACEI or ARB
  • Either gender

Exclusion Criteria:

  • HIV negative status
  • Age < 1 or > 21 years of age
  • Unable to tolerate discontinuation of ACEI or ARB
  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: NCT00153621

Locations
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Children's Research Institute
Investigators
Principal Investigator: Kevin D. McBryde, MD Children's Research Institute
Study Director: Susan L. Furth, MD, PhD Johns Hopkins University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00153621     History of Changes
Other Study ID Numbers: 3406, NCRR 1K12RR017613-01
Study First Received: September 8, 2005
Last Updated: May 2, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Research Institute:
Pediatrics
Chronic Kidney Failure
HIV
Acquired Immunodeficiency Syndrome
AIDS-Associated Nephropathy

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Kidney Diseases
Kidney Failure, Chronic
Proteinuria
Renal Insufficiency
AIDS-Associated Nephropathy
Renal Insufficiency, Chronic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014