Clinical trial NCT00037076: 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
Overall status: COMPLETED
Conditions: HIV Infections
Hepatitis C
Keywords: HIV Seropositivity
Hepatitis C
Polymerase Chain Reaction
RNA, Viral
Prevalence
Disease Transmission, Vertical
Hepacivirus
Enzyme Immunoassay
GB virus C
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2002-05-15
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham - Pediatric
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Childrens Hosp
state: Arizona
city: Los Angeles
country: United States
facility: Los Angeles County - USC Med Ctr
state: California
city: Oakland
country: United States
facility: Children's Hosp of Oakland
state: California
city: San Diego
country: United States
facility: Univ of California, San Diego
state: California
city: San Francisco
country: United States
facility: UCSF, Moffitt Hospital (Pediatric)
state: California
city: Denver
country: United States
facility: Children's Hosp of Denver
state: Colorado
city: Farmington
country: United States
facility: Connecticut Childrens Med Ctr (Pediatric)
state: Connecticut
city: New Haven
country: United States
facility: Yale Univ Med School
state: Connecticut
city: Washington
country: United States
facility: Howard Univ Hosp
state: District of Columbia
city: Miami
country: United States
facility: Univ of Miami (Pediatric)
state: Florida
city: Augusta
country: United States
facility: Med College of Georgia
state: Georgia
city: Columbus
country: United States
facility: The Med Ctr Inc
state: Georgia
city: Chicago
country: United States
facility: Mt Sinai Hosp Med Ctr / Dept of Pediatrics
state: Illinois
city: Chicago
country: United States
facility: The Univ of Chicago Children's Hosp
state: Illinois
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: New Orleans
country: United States
facility: Tulane Univ / Charity Hosp of New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: Univ of Maryland at Baltimore / Univ Med Ctr
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hosp - Pediatric
state: Maryland
city: Springfield
country: United States
facility: Baystate Med Ctr of Springfield
state: Massachusetts
city: Worcester
country: United States
facility: Univ of Massachusetts Med School
state: Massachusetts
city: Detroit
country: United States
facility: Children's Hosp of Michigan
state: Michigan
city: Newark
country: United States
facility: Univ of Medicine & Dentistry of New Jersey / Univ Hosp
state: New Jersey
city: Brooklyn
country: United States
facility: Children's Hospital at SUNY Downstate
state: New York
city: New York
country: United States
facility: Mount Sinai Med Ctr
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Med Ctr
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Med Ctr
state: New York
city: Stony Brook
country: United States
facility: State Univ of New York at Stony Brook
state: New York
city: Syracuse
country: United States
facility: SUNY Health Sciences Ctr at Syracuse / Pediatrics
state: New York
city: Chapel Hill
country: United States
facility: Univ of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University (Pediatric)
state: North Carolina
city: Philadelphia
country: United States
facility: Childrens Hosp of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: St. Christopher's Hosp for Children, Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: Saint Jude Children's Research Hosp of Memphis
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Univ Med Ctr
state: Tennessee
city: Dallas
country: United States
facility: Children's Med Ctr of Dallas
state: Texas
city: Houston
country: United States
facility: Texas Children's Hosp / Baylor Univ
state: Texas
city: San Juan
country: Puerto Rico
facility: Univ. of Puerto Rico, U. Children's Hospital AIDS
city: San Juan
country: Puerto Rico
facility: San Juan City Hosp
Study officials:
name: Susan Schuval
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.