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Prevalence of Hepatitis C Virus Infection in HIV-Infected Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00037076
First Posted: May 15, 2002
Last Update Posted: October 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
May 14, 2002
May 15, 2002
October 31, 2012
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Complete list of historical versions of study NCT00037076 on ClinicalTrials.gov Archive Site
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Prevalence of Hepatitis C Virus Infection in HIV-Infected Children
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.

Observational
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  • HIV Infections
  • Hepatitis C
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
July 2003
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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.
Sexes Eligible for Study: All
1 Year to 20 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00037076
PACTG P1028S
11657 ( Registry Identifier: DAIDS ES Registry Number )
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: Susan Schuval
National Institute of Allergy and Infectious Diseases (NIAID)
October 2012