Prevalence of Hepatitis C Virus Infection in HIV-Infected Children
NCT ID: NCT00037076
Last Updated: 2012-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
600 participants
OBSERVATIONAL
2003-07-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Eligibility Criteria
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Inclusion Criteria
* 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
* Have hemophilia.
* Contracted HIV through a route other than from the mother around the time of birth.
1 Year
20 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Susan Schuval
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States
Phoenix Childrens Hosp
Phoenix, Arizona, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
Children's Hosp of Oakland
Oakland, California, United States
Univ of California, San Diego
San Diego, California, United States
UCSF, Moffitt Hospital (Pediatric)
San Francisco, California, United States
Children's Hosp of Denver
Denver, Colorado, United States
Connecticut Childrens Med Ctr (Pediatric)
Farmington, Connecticut, United States
Yale Univ Med School
New Haven, Connecticut, United States
Howard Univ Hosp
Washington D.C., District of Columbia, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Med College of Georgia
Augusta, Georgia, United States
The Med Ctr Inc
Columbus, Georgia, United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, United States
The Univ of Chicago Children's Hosp
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, United States
Children's Hosp of Michigan
Detroit, Michigan, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States
Children's Hospital at SUNY Downstate
Brooklyn, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Columbia Presbyterian Med Ctr
New York, New York, United States
Univ of Rochester Med Ctr
Rochester, New York, United States
State Univ of New York at Stony Brook
Stony Brook, New York, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States
Univ of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University (Pediatric)
Durham, North Carolina, United States
Childrens Hosp of Philadelphia
Philadelphia, Pennsylvania, United States
St. Christopher's Hosp for Children, Philadelphia
Philadelphia, Pennsylvania, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States
Children's Med Ctr of Dallas
Dallas, Texas, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States
Univ. of Puerto Rico, U. Children's Hospital AIDS
San Juan, , Puerto Rico
San Juan City Hosp
San Juan, , Puerto Rico
Countries
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References
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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.
Other Identifiers
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11657
Identifier Type: REGISTRY
Identifier Source: secondary_id
PACTG P1028S
Identifier Type: -
Identifier Source: org_study_id