Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00153621
Other study ID # 3406
Secondary ID NCRR 1K12RR01761
Status Completed
Phase N/A
First received September 8, 2005
Last updated May 2, 2008
Start date September 2004
Est. completion date September 2007

Study information

Verified date September 2005
Source Children's Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 320
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 21 Years
Eligibility 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

Study Design

Time Perspective: Prospective


Locations

Country Name City State
United States Children's National Medical Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Children's Research Institute

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2