We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevalence of Hepatitis C Virus Infection in HIV-Infected Children

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.
ClinicalTrials.gov Identifier: NCT00037076
Recruitment Status : Completed
First Posted : May 15, 2002
Last Update Posted : October 31, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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).


Condition or disease
HIV Infections Hepatitis 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.


Study Design

Study Type : Observational
Estimated Enrollment : 600 participants
Official Title: Hepatitis C Prevalence in Perinatally Infected HIV-Positive Children Enrolled in PACTG 219C
Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037076


  Show 39 Study Locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Study Chair: Susan Schuval
More 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 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: May 15, 2002    Key Record Dates
Last Update Posted: October 31, 2012
Last Verified: October 2012

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:
Infection
Hepatitis
Hepatitis A
Hepatitis C
HIV Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases