Prevalence of Hepatitis C Virus Infection in HIV-Infected Children

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: Hepatitis C; HIV Infections

Study type: Observational

Funder types: NIH

Identifiers

NCT00037076

PACTG P1028S

11657 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 1 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.