Prevalence of Hepatitis C Virus Infection in HIV-Infected Children
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Purpose
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).
| Condition |
|---|
|
HIV Infections Hepatitis C |
| Study Type: | Observational |
| Official Title: | Hepatitis C Prevalence in Perinatally Infected HIV-Positive Children Enrolled in PACTG 219C |
| Estimated Enrollment: | 600 |
| Study Completion Date: | July 2003 |
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| Ages Eligible for Study: | 1 Year to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham - Pediatric | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Arizona | |
| Phoenix Childrens Hosp | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| Children's Hosp of Oakland | |
| Oakland, California, United States, 94609-1809 | |
| Univ of California, San Diego | |
| San Diego, California, United States, 92103 | |
| UCSF, Moffitt Hospital (Pediatric) | |
| San Francisco, California, United States, 94143 | |
| United States, Colorado | |
| Children's Hosp of Denver | |
| Denver, Colorado, United States, 802181088 | |
| United States, Connecticut | |
| Connecticut Childrens Med Ctr (Pediatric) | |
| Farmington, Connecticut, United States, 06030 | |
| Yale Univ Med School | |
| New Haven, Connecticut, United States, 06504 | |
| United States, District of Columbia | |
| Howard Univ Hosp | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Florida | |
| Univ of Miami (Pediatric) | |
| Miami, Florida, United States, 33161 | |
| United States, Georgia | |
| Med College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| The Med Ctr Inc | |
| Columbus, Georgia, United States, 31901 | |
| United States, Illinois | |
| Mt Sinai Hosp Med Ctr / Dept of Pediatrics | |
| Chicago, Illinois, United States, 60608 | |
| University of Illinois | |
| Chicago, Illinois, United States, 60612 | |
| The Univ of Chicago Children's Hosp | |
| Chicago, Illinois, United States, 60612 | |
| United States, Louisiana | |
| Tulane Univ / Charity Hosp of New Orleans | |
| New Orleans, Louisiana, United States, 701122699 | |
| United States, Maryland | |
| Univ of Maryland at Baltimore / Univ Med Ctr | |
| Baltimore, Maryland, United States, 21201 | |
| Johns Hopkins Hosp - Pediatric | |
| Baltimore, Maryland, United States, 21287-4933 | |
| United States, Massachusetts | |
| Baystate Med Ctr of Springfield | |
| Springfield, Massachusetts, United States, 01199 | |
| Univ of Massachusetts Med School | |
| Worcester, Massachusetts, United States, 016550001 | |
| United States, Michigan | |
| Children's Hosp of Michigan | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| Univ of Medicine & Dentistry of New Jersey / Univ Hosp | |
| Newark, New Jersey, United States, 071032714 | |
| United States, New York | |
| Children's Hospital at SUNY Downstate | |
| Brooklyn, New York, United States, 11203 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 10032 | |
| Univ of Rochester Med Ctr | |
| Rochester, New York, United States, 146420001 | |
| State Univ of New York at Stony Brook | |
| Stony Brook, New York, United States, 117948111 | |
| SUNY Health Sciences Ctr at Syracuse / Pediatrics | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Univ of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Duke University (Pediatric) | |
| Durham, North Carolina, United States, 27705 | |
| United States, Pennsylvania | |
| St. Christopher's Hosp for Children, Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19134 | |
| Childrens Hosp of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| Saint Jude Children's Research Hosp of Memphis | |
| Memphis, Tennessee, United States, 381052794 | |
| Vanderbilt Univ Med Ctr | |
| Nashville, Tennessee, United States, 372322581 | |
| United States, Texas | |
| Children's Med Ctr of Dallas | |
| Dallas, Texas, United States, 75235 | |
| Texas Children's Hosp / Baylor Univ | |
| Houston, Texas, United States, 77030 | |
| Puerto Rico | |
| San Juan City Hosp | |
| San Juan, Puerto Rico, 009367344 | |
| Univ. of Puerto Rico, U. Children's Hospital AIDS | |
| San Juan, Puerto Rico, 00936-5067 | |
| Study Chair: | Susan Schuval |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00037076 History of Changes |
| Other Study ID Numbers: | PACTG P1028S, 11657 |
| Study First Received: | May 14, 2002 |
| Last Updated: | October 30, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
HIV Seropositivity Hepatitis C Polymerase Chain Reaction RNA, Viral Prevalence |
Disease Transmission, Vertical Hepacivirus Enzyme Immunoassay GB virus C |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis C Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on May 23, 2013