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).

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment: 600

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Study Chair: Susan Schuval

Publications and helpful links

General Publications

• Tajiri H, Miyoshi Y, Funada S, Etani Y, Abe J, Onodera T, Goto M, Funato M, Ida S, Noda C, Nakayama M, Okada S. Prospective study of mother-to-infant transmission of hepatitis C virus. Pediatr Infect Dis J. 2001 Jan;20(1):10-4. doi: 10.1097/00006454-200101000-00003.
• Tillmann HL, Heiken H, Knapik-Botor A, Heringlake S, Ockenga J, Wilber JC, Goergen B, Detmer J, McMorrow M, Stoll M, Schmidt RE, Manns MP. Infection with GB virus C and reduced mortality among HIV-infected patients. N Engl J Med. 2001 Sep 6;345(10):715-24. doi: 10.1056/NEJMoa010398.
• Xiang J, Wunschmann S, Diekema DJ, Klinzman D, Patrick KD, George SL, Stapleton JT. Effect of coinfection with GB virus C on survival among patients with HIV infection. N Engl J Med. 2001 Sep 6;345(10):707-14. doi: 10.1056/NEJMoa003364.
• Thomas SL, Newell ML, Peckham CS, Ades AE, Hall AJ. A review of hepatitis C virus (HCV) vertical transmission: risks of transmission to infants born to mothers with and without HCV viraemia or human immunodeficiency virus infection. Int J Epidemiol. 1998 Feb;27(1):108-17. doi: 10.1093/ije/27.1.108.
• Papaevangelou V, Pollack H, Rochford G, Kokka R, Hou Z, Chernoff D, Hanna B, Krasinski K, Borkowsky W. Increased transmission of vertical hepatitis C virus (HCV) infection to human immunodeficiency virus (HIV)-infected infants of HIV- and HCV-coinfected women. J Infect Dis. 1998 Oct;178(4):1047-52. doi: 10.1086/515668.

Study record dates

Study Major Dates

• Study Completion (Actual): July 1, 2003

Study Registration Dates

• First Submitted: May 14, 2002
• First Submitted That Met QC Criteria: May 14, 2002
• First Posted (Estimate): May 15, 2002

Study Record Updates

• Last Update Posted (Estimate): October 31, 2012
• Last Update Submitted That Met QC Criteria: October 30, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Disease Transmission, Vertical; Prevalence; RNA, Viral; Hepatitis C; HIV Seropositivity; Polymerase Chain Reaction; Hepacivirus; Enzyme Immunoassay; GB virus C
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: PACTG P1028S; 11657 (Registry Identifier: DAIDS ES Registry Number)