Prevalence of Hepatitis C Virus Infection in HIV-Infected Children

Hepatitis C Prevalence in Perinatally Infected HIV-Positive Children Enrolled in PACTG 219C

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00037076

Enrollment

600

Registered

2002-05-15

Start date

Unknown

Completion date

2003-07-31

Last updated

2012-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, HIV Infections

Keywords

HIV Seropositivity, Hepatitis C, Polymerase Chain Reaction, RNA, Viral, Prevalence, Disease Transmission, Vertical, Hepacivirus, Enzyme Immunoassay, GB virus C

Brief summary

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).

Detailed description

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.

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

1 Years to 20 Years

Healthy volunteers

Inclusion criteria

Patients may be eligible for this substudy if they: * Are between 1 year and 20 years of age. * Were infected with HIV from the mother at or around the time of birth. * Are enrolled in PACTG 219C. * Children known to be HCV-infected will be permitted to enter the substudy.

Exclusion criteria

Patients may not be eligible for this substudy if they: * Have hemophilia. * Contracted HIV through a route other than from the mother around the time of birth.

Countries

Puerto Rico, United States

Outcome results