Prevalence of Hepatitis C Virus Infection in HIV-Infected Children
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Purpose
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).
| Condition |
|---|
|
HIV Infections Hepatitis C |
| Study Type: | Observational |
| Official Title: | Hepatitis C Prevalence in Perinatally Infected HIV-Positive Children Enrolled in PACTG 219C |
| Estimated Enrollment: | 600 |
| Study Completion Date: | July 2003 |
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.
Eligibility| Ages Eligible for Study: | 1 Year to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Show 39 Study Locations| Study Chair: | Susan Schuval |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00037076 History of Changes |
| Other Study ID Numbers: | PACTG P1028S, 11657 |
| Study First Received: | May 14, 2002 |
| Last Updated: | October 30, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
HIV Seropositivity Hepatitis C Polymerase Chain Reaction RNA, Viral Prevalence |
Disease Transmission, Vertical Hepacivirus Enzyme Immunoassay GB virus C |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis C Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on June 18, 2013