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Home > "P" Clinical Trials Conditions > Prevalence of Hepatitis C Virus Infection in HIV-Infected Children  Prevalence of Hepatitis C Virus Infection in HIV-Infected Children
Prevalence of Hepatitis C Virus Infection in HIV-Infected Children
For Condition: Hepatitis C,HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: 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).
Details: 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:
Study Type: Observational, Screening, Defined Population
Minimum Age/Maximum Age: 1 Year/20 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 600
Location and Contact Information:
Overall Study Official:
SusanSchuval, Study Chair,
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Univ. of Puerto Rico, U. Children's Hospital AIDS
San Juan, , 00936-5067
Puerto Rico
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608
United States
Children's Hosp of Oakland
Oakland, California, 94609-1809
United States
Univ of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
The Univ of Chicago Children's Hosp
Chicago, Illinois, 60612
United States
St. Christopher's Hosp for Children, Philadelphia
Philadelphia, Pennsylvania, 19134
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
University of Illinois
Chicago, Illinois, 60612
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 372322581
United States
UCSF, Moffitt Hospital (Pediatric)
San Francisco, California, 94143
United States
Univ of California, San Diego
San Diego, California, 92103
United States
Univ of Rochester Med Ctr
Rochester, New York, 146420001
United States
Duke University (Pediatric)
Durham, North Carolina, 27705
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Connecticut Childrens Med Ctr (Pediatric)
Farmington, Connecticut, 06030
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
The Med Ctr Inc
Columbus, Georgia, 31901
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Phoenix Childrens Hosp
Phoenix, Arizona, 85006
United States
Childrens Hosp of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 21287-4933
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Children's Hospital at SUNY Downstate
Brooklyn, New York, 11203
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Children's Med Ctr of Dallas
Dallas, Texas, 75235
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Additional Information:
Study ID Numbers: PACTG P1028S;
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037076
Other Hiv Infections Studies:
1. An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Dideoxycytidine (ddC) in Patients With AIDS or Advanced ARC Who Previously Demonstrated Intolerance to Zidovudine (AZT) in Protocol N3300 or N3492
2. A Study of DTC in Patients With AIDS and AIDS Related Complex
3. HIV Infection in Homosexual and Bisexual Men
4. A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients
5. Evaluation of the Interaction Between High Dose Sulfamethoxazole/Trimethoprim and Zidovudine
Related Studies:
Other HIV Infections Clinical Trials
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Other Miami Clinical Trials
Prevalence of Hepatitis C Virus Infection in HIV-Infected Children
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