From, clinicaltrials.

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

-MedlinePlus related topics: AIDS Kidney Failure

U.S. FDA Resources

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

-Estimated Enrollment: 320

-Study Start Date: September 2004

-Study Completion Date: September 2007

 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

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