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

Further Study Details: 

Expected Total Enrollment:  600

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.

Ages Eligible for Study:  1 Year   -   20 Years,  Genders Eligible for Study:  Both

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.

Alabama
      Univ of Alabama at Birmingham - Pediatric, Birmingham,  Alabama,  35233,  United States
Arizona
      Phoenix Childrens Hosp, Phoenix,  Arizona,  85006,  United States
California
      Los Angeles County - USC Med Ctr, Los Angeles,  California,  90033,  United States
      Univ of California, San Diego, San Diego,  California,  92103,  United States
      Children's Hosp of Oakland, Oakland,  California,  94609-1809,  United States
      UCSF, Moffitt Hospital (Pediatric), San Francisco,  California,  94143,  United States
Colorado
      Children's Hosp of Denver, Denver,  Colorado,  802181088,  United States
Connecticut
      Yale Univ Med School, New Haven,  Connecticut,  06504,  United States
      Connecticut Childrens Med Ctr (Pediatric), Farmington,  Connecticut,  06030,  United States
District of Columbia
      Howard Univ Hosp, Washington,  District of Columbia,  20060,  United States
Florida
      Univ of Miami (Pediatric), Miami,  Florida,  33161,  United States
Georgia
      Med College of Georgia, Augusta,  Georgia,  30912,  United States
      The Med Ctr Inc, Columbus,  Georgia,  31901,  United States
Illinois
      Mt Sinai Hosp Med Ctr / Dept of Pediatrics, Chicago,  Illinois,  60608,  United States
      University of Illinois, Chicago,  Illinois,  60612,  United States
      The Univ of Chicago Children's Hosp, Chicago,  Illinois,  60612,  United States
Louisiana
      Tulane Univ / Charity Hosp of New Orleans, New Orleans,  Louisiana,  701122699,  United States
Maryland
      Univ of Maryland at Baltimore / Univ Med Ctr, Baltimore,  Maryland,  21201,  United States
      Johns Hopkins Hosp - Pediatric, Baltimore,  Maryland,  21287-4933,  United States
Massachusetts
      Baystate Med Ctr of Springfield, Springfield,  Massachusetts,  01199,  United States
      Univ of Massachusetts Med School, Worcester,  Massachusetts,  016550001,  United States
Michigan
      Children's Hosp of Michigan, Detroit,  Michigan,  48201,  United States
New Jersey
      Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark,  New Jersey,  071032714,  United States
New York
      Mount Sinai Med Ctr, New York,  New York,  10029,  United States
      SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse,  New York,  13210,  United States
      State Univ of New York at Stony Brook, Stony Brook,  New York,  117948111,  United States
      Univ of Rochester Med Ctr, Rochester,  New York,  146420001,  United States
      Children's Hospital at SUNY Downstate, Brooklyn,  New York,  11203,  United States
      Columbia Presbyterian Med Ctr, New York,  New York,  10032,  United States
North Carolina
      Univ of North Carolina at Chapel Hill, Chapel Hill,  North Carolina,  27599,  United States
      Duke University (Pediatric), Durham,  North Carolina,  27705,  United States
Pennsylvania
      St. Christopher's Hosp for Children, Philadelphia, Philadelphia,  Pennsylvania,  19134,  United States
      Childrens Hosp of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States
Tennessee
      Saint Jude Children's Research Hosp of Memphis, Memphis,  Tennessee,  381052794,  United States
      Vanderbilt Univ Med Ctr, Nashville,  Tennessee,  372322581,  United States
Texas
      Children's Med Ctr of Dallas, Dallas,  Texas,  75235,  United States
      Texas Children's Hosp / Baylor Univ, Houston,  Texas,  77030,  United States
Puerto Rico
      San Juan City Hosp, San Juan,  009367344,  Puerto Rico
      Univ. of Puerto Rico, U. Children's Hospital AIDS, San Juan,  00936-5067,  Puerto Rico

Study chairs or principal investigators

Susan Schuval,  Study Chair

Study ID Numbers:  PACTG P1028S
Record last reviewed:  August 2004
Last Updated:  April 7, 2005
Record first received:  May 14, 2002
ClinicalTrials.gov Identifier:  NCT00037076
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08