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Hepatitis C Prevalence in Perinatally Infected HIV-Positive Children Enrolled in PACTG 219C
The purpose of this study is to find out how many children who are infected with HIV are also infected with hepatitis C virus (HCV). HCV infection is a major health concern. HIV-infected adults who are co-infected with HCV appear to have more rapid HIV disease progression. There is little data on how widespread HCV is among children who are HIV-infected. Information from this study will help determine the need for future HCV studies. This study also will obtain blood samples for future testing for other hepatitis viruses such as hepatitis G virus (HGV or GB virus C).
HCV infection is a major public health concern with worldwide seroprevalence estimated at 1 percent. HIV-infected adults co-infected with HCV appear to have accelerated HIV disease progression. There is little data on HCV prevalence in the pediatric HIV-infected population. This substudy will provide estimates of HCV prevalence among HIV-infected children and determine the need for future HCV natural history and treatment protocols. In addition, this substudy will archive samples from patients for future testing for other hepatitis viruses such as hepatitis G virus (HGV or GB virus C). Patients participating in PACTG 219C are selected randomly to enroll into PACTG P1028S. Patients who agree to participate have a single blood draw for HCV antibody (Enzyme Immunoassay-EIA) testing and HCV RNA (Polymerase Chain Reaction-PCR) testing. An additional blood draw is necessary in the case of discordant results between the HCV EIA and HCV PCR. HCV-negative patients have 1 study visit. Patients with positive HCV test results have 2 visits. Patients with discordant HCV test results have 2 or 3 visits.
Age
1 - 20 years
Sex
ALL
Healthy Volunteers
No
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States
Phoenix Childrens Hosp
Phoenix, Arizona, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
Children's Hosp of Oakland
Oakland, California, United States
Univ of California, San Diego
San Diego, California, United States
UCSF, Moffitt Hospital (Pediatric)
San Francisco, California, United States
Children's Hosp of Denver
Denver, Colorado, United States
Connecticut Childrens Med Ctr (Pediatric)
Farmington, Connecticut, United States
Yale Univ Med School
New Haven, Connecticut, United States
Howard Univ Hosp
Washington D.C., District of Columbia, United States
Completion Date
July 1, 2003
Last Updated
October 31, 2012
600
Estimated participants
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
NCT04142047
NCT06694805
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06953479