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NCT00037076 Clinical Trial

Prevalence of Hepatitis C Virus Infection in HIV-Infected Children

HIV Infections Clinical Trial

Official title:
Hepatitis C Prevalence in Perinatally Infected HIV-Positive Children Enrolled in PACTG 219C

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00037076
Other study ID # PACTG P1028S
Secondary ID 11657
Status Completed
Phase N/A
First received May 14, 2002
Last updated October 30, 2012
Est. completion date July 2003

Study information
Verified date October 2012
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date July 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 20 Years
Eligibility 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 Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
Puerto Rico San Juan City Hosp San Juan
Puerto Rico Univ. of Puerto Rico, U. Children's Hospital AIDS San Juan
United States Med College of Georgia Augusta Georgia
United States Johns Hopkins Hosp - Pediatric Baltimore Maryland
United States Univ of Maryland at Baltimore / Univ Med Ctr Baltimore Maryland
United States Univ of Alabama at Birmingham - Pediatric Birmingham Alabama
United States Children's Hospital at SUNY Downstate Brooklyn New York
United States Univ of North Carolina at Chapel Hill Chapel Hill North Carolina
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 The Med Ctr Inc Columbus Georgia
United States Children's Med Ctr of Dallas Dallas Texas
United States Children's Hosp of Denver Denver Colorado
United States Children's Hosp of Michigan Detroit Michigan
United States Duke University (Pediatric) Durham North Carolina
United States Connecticut Childrens Med Ctr (Pediatric) Farmington Connecticut
United States Texas Children's Hosp / Baylor Univ Houston Texas
United States Los Angeles County - USC Med Ctr Los Angeles California
United States Saint Jude Children's Research Hosp of Memphis Memphis Tennessee
United States Univ of Miami (Pediatric) Miami Florida
United States Vanderbilt Univ Med Ctr Nashville Tennessee
United States Yale Univ Med School New Haven Connecticut
United States Tulane Univ / Charity Hosp of New Orleans New Orleans Louisiana
United States Columbia Presbyterian Med Ctr New York New York
United States Mount Sinai Med Ctr New York New York
United States Univ of Medicine & Dentistry of New Jersey / Univ Hosp Newark New Jersey
United States Children's Hosp of Oakland Oakland California
United States Childrens Hosp of Philadelphia Philadelphia Pennsylvania
United States St. Christopher's Hosp for Children, Philadelphia Philadelphia Pennsylvania
United States Phoenix Childrens Hosp Phoenix Arizona
United States Univ of Rochester Med Ctr Rochester New York
United States Univ of California, San Diego San Diego California
United States UCSF, Moffitt Hospital (Pediatric) San Francisco California
United States Baystate Med Ctr of Springfield Springfield Massachusetts
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 Howard Univ Hosp Washington District of Columbia
United States Univ of Massachusetts Med School Worcester Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (5)

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. — View 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. — View 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. Review. — View 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. — View Citation

Xiang J, Wünschmann 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. — View Citation

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