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Prevalence of Hepatitis C Virus Infection in HIV-Infected Children

Primary Purpose

HIV Infections, Hepatitis C

Status
Completed
Phase
Locations
International
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring HIV Seropositivity, Hepatitis C, Polymerase Chain Reaction, RNA, Viral, Prevalence, Disease Transmission, Vertical, Hepacivirus, Enzyme Immunoassay, GB virus C

Eligibility Criteria

1 Year - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Alabama at Birmingham - Pediatric
  • Phoenix Childrens Hosp
  • Los Angeles County - USC Med Ctr
  • Children's Hosp of Oakland
  • Univ of California, San Diego
  • UCSF, Moffitt Hospital (Pediatric)
  • Children's Hosp of Denver
  • Connecticut Childrens Med Ctr (Pediatric)
  • Yale Univ Med School
  • Howard Univ Hosp
  • Univ of Miami (Pediatric)
  • Med College of Georgia
  • The Med Ctr Inc
  • Mt Sinai Hosp Med Ctr / Dept of Pediatrics
  • The Univ of Chicago Children's Hosp
  • University of Illinois
  • Tulane Univ / Charity Hosp of New Orleans
  • Univ of Maryland at Baltimore / Univ Med Ctr
  • Johns Hopkins Hosp - Pediatric
  • Baystate Med Ctr of Springfield
  • Univ of Massachusetts Med School
  • Children's Hosp of Michigan
  • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
  • Children's Hospital at SUNY Downstate
  • Mount Sinai Med Ctr
  • Columbia Presbyterian Med Ctr
  • Univ of Rochester Med Ctr
  • State Univ of New York at Stony Brook
  • SUNY Health Sciences Ctr at Syracuse / Pediatrics
  • Univ of North Carolina at Chapel Hill
  • Duke University (Pediatric)
  • Childrens Hosp of Philadelphia
  • St. Christopher's Hosp for Children, Philadelphia
  • Saint Jude Children's Research Hosp of Memphis
  • Vanderbilt Univ Med Ctr
  • Children's Med Ctr of Dallas
  • Texas Children's Hosp / Baylor Univ
  • Univ. of Puerto Rico, U. Children's Hospital AIDS
  • San Juan City Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 14, 2002
Last Updated
October 30, 2012
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00037076
Brief Title
Prevalence of Hepatitis C Virus Infection in HIV-Infected Children
Official Title
Hepatitis C Prevalence in Perinatally Infected HIV-Positive Children Enrolled in PACTG 219C
Study Type
Observational

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hepatitis C
Keywords
HIV Seropositivity, Hepatitis C, Polymerase Chain Reaction, RNA, Viral, Prevalence, Disease Transmission, Vertical, Hepacivirus, Enzyme Immunoassay, GB virus C

7. Study Design

Enrollment
600 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Schuval
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham - Pediatric
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Phoenix Childrens Hosp
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Children's Hosp of Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609-1809
Country
United States
Facility Name
Univ of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCSF, Moffitt Hospital (Pediatric)
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Children's Hosp of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
802181088
Country
United States
Facility Name
Connecticut Childrens Med Ctr (Pediatric)
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Yale Univ Med School
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
Howard Univ Hosp
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Univ of Miami (Pediatric)
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Med College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
The Med Ctr Inc
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31901
Country
United States
Facility Name
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
The Univ of Chicago Children's Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Tulane Univ / Charity Hosp of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
Univ of Maryland at Baltimore / Univ Med Ctr
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Hosp - Pediatric
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-4933
Country
United States
Facility Name
Baystate Med Ctr of Springfield
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Univ of Massachusetts Med School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
016550001
Country
United States
Facility Name
Children's Hosp of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032714
Country
United States
Facility Name
Children's Hospital at SUNY Downstate
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
146420001
Country
United States
Facility Name
State Univ of New York at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948111
Country
United States
Facility Name
SUNY Health Sciences Ctr at Syracuse / Pediatrics
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Univ of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University (Pediatric)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Childrens Hosp of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
St. Christopher's Hosp for Children, Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Saint Jude Children's Research Hosp of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
381052794
Country
United States
Facility Name
Vanderbilt Univ Med Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
372322581
Country
United States
Facility Name
Children's Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Children's Hosp / Baylor Univ
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ. of Puerto Rico, U. Children's Hospital AIDS
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
Facility Name
San Juan City Hosp
City
San Juan
ZIP/Postal Code
009367344
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
11176560
Citation
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.
Results Reference
background
PubMed Identifier
11547740
Citation
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.
Results Reference
background
PubMed Identifier
11547739
Citation
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.
Results Reference
background
PubMed Identifier
9563703
Citation
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.
Results Reference
background
PubMed Identifier
9806033
Citation
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.
Results Reference
background

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Prevalence of Hepatitis C Virus Infection in HIV-Infected Children

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