Prevalence of Hepatitis C Virus Infection in HIV-Infected Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00037076
First received: May 14, 2002
Last updated: October 30, 2012
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 600
Study Completion Date: July 2003
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.

  Eligibility

Ages Eligible for Study:   1 Year to 20 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037076

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States, 35233
United States, Arizona
Phoenix Childrens Hosp
Phoenix, Arizona, United States, 85006
United States, California
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Children's Hosp of Oakland
Oakland, California, United States, 94609-1809
Univ of California, San Diego
San Diego, California, United States, 92103
UCSF, Moffitt Hospital (Pediatric)
San Francisco, California, United States, 94143
United States, Colorado
Children's Hosp of Denver
Denver, Colorado, United States, 802181088
United States, Connecticut
Connecticut Childrens Med Ctr (Pediatric)
Farmington, Connecticut, United States, 06030
Yale Univ Med School
New Haven, Connecticut, United States, 06504
United States, District of Columbia
Howard Univ Hosp
Washington, District of Columbia, United States, 20060
United States, Florida
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
United States, Georgia
Med College of Georgia
Augusta, Georgia, United States, 30912
The Med Ctr Inc
Columbus, Georgia, United States, 31901
United States, Illinois
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, United States, 60608
University of Illinois
Chicago, Illinois, United States, 60612
The Univ of Chicago Children's Hosp
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
United States, Maryland
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States, 21287-4933
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Univ of Massachusetts Med School
Worcester, Massachusetts, United States, 016550001
United States, Michigan
Children's Hosp of Michigan
Detroit, Michigan, United States, 48201
United States, New Jersey
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
United States, New York
Children's Hospital at SUNY Downstate
Brooklyn, New York, United States, 11203
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Mount Sinai Med Ctr
New York, New York, United States, 10029
Univ of Rochester Med Ctr
Rochester, New York, United States, 146420001
State Univ of New York at Stony Brook
Stony Brook, New York, United States, 117948111
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States, 13210
United States, North Carolina
Univ of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University (Pediatric)
Durham, North Carolina, United States, 27705
United States, Pennsylvania
Childrens Hosp of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
St. Christopher's Hosp for Children, Philadelphia
Philadelphia, Pennsylvania, United States, 19134
United States, Tennessee
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States, 381052794
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States, 372322581
United States, Texas
Children's Med Ctr of Dallas
Dallas, Texas, United States, 75235
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States, 77030
Puerto Rico
Univ. of Puerto Rico, U. Children's Hospital AIDS
San Juan, Puerto Rico, 00936-5067
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Sponsors and Collaborators
Investigators
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:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Flaviviridae Infections

ClinicalTrials.gov processed this record on October 19, 2014