HIV Infections Clinical Trial
Official title:
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.
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