NCT00037076

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).

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Geographic Reach
2 countries

39 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2002

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

First QC Date

May 14, 2002

Last Update Submit

October 30, 2012

Conditions

Keywords

HIV SeropositivityHepatitis CPolymerase Chain ReactionRNA, ViralPrevalenceDisease Transmission, VerticalHepacivirusEnzyme ImmunoassayGB virus C

Eligibility Criteria

Age1 Year - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

Univ of Alabama at Birmingham - Pediatric

Birmingham, Alabama, 35233, United States

Location

Phoenix Childrens Hosp

Phoenix, Arizona, 85006, United States

Location

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

Children's Hosp of Oakland

Oakland, California, 94609-1809, United States

Location

Univ of California, San Diego

San Diego, California, 92103, United States

Location

UCSF, Moffitt Hospital (Pediatric)

San Francisco, California, 94143, United States

Location

Children's Hosp of Denver

Denver, Colorado, 802181088, United States

Location

Connecticut Childrens Med Ctr (Pediatric)

Farmington, Connecticut, 06030, United States

Location

Yale Univ Med School

New Haven, Connecticut, 06504, United States

Location

Howard Univ Hosp

Washington D.C., District of Columbia, 20060, United States

Location

Univ of Miami (Pediatric)

Miami, Florida, 33161, United States

Location

Med College of Georgia

Augusta, Georgia, 30912, United States

Location

The Med Ctr Inc

Columbus, Georgia, 31901, United States

Location

Mt Sinai Hosp Med Ctr / Dept of Pediatrics

Chicago, Illinois, 60608, United States

Location

The Univ of Chicago Children's Hosp

Chicago, Illinois, 60612, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

Tulane Univ / Charity Hosp of New Orleans

New Orleans, Louisiana, 701122699, United States

Location

Univ of Maryland at Baltimore / Univ Med Ctr

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Hosp - Pediatric

Baltimore, Maryland, 21287-4933, United States

Location

Baystate Med Ctr of Springfield

Springfield, Massachusetts, 01199, United States

Location

Univ of Massachusetts Med School

Worcester, Massachusetts, 016550001, United States

Location

Children's Hosp of Michigan

Detroit, Michigan, 48201, United States

Location

Univ of Medicine & Dentistry of New Jersey / Univ Hosp

Newark, New Jersey, 071032714, United States

Location

Children's Hospital at SUNY Downstate

Brooklyn, New York, 11203, United States

Location

Mount Sinai Med Ctr

New York, New York, 10029, United States

Location

Columbia Presbyterian Med Ctr

New York, New York, 10032, United States

Location

Univ of Rochester Med Ctr

Rochester, New York, 146420001, United States

Location

State Univ of New York at Stony Brook

Stony Brook, New York, 117948111, United States

Location

SUNY Health Sciences Ctr at Syracuse / Pediatrics

Syracuse, New York, 13210, United States

Location

Univ of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University (Pediatric)

Durham, North Carolina, 27705, United States

Location

Childrens Hosp of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

St. Christopher's Hosp for Children, Philadelphia

Philadelphia, Pennsylvania, 19134, United States

Location

Saint Jude Children's Research Hosp of Memphis

Memphis, Tennessee, 381052794, United States

Location

Vanderbilt Univ Med Ctr

Nashville, Tennessee, 372322581, United States

Location

Children's Med Ctr of Dallas

Dallas, Texas, 75235, United States

Location

Texas Children's Hosp / Baylor Univ

Houston, Texas, 77030, United States

Location

Univ. of Puerto Rico, U. Children's Hospital AIDS

San Juan, 00936-5067, Puerto Rico

Location

San Juan City Hosp

San Juan, 009367344, Puerto Rico

Location

Related Publications (5)

  • 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.

    PMID: 11176560BACKGROUND
  • 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.

    PMID: 11547740BACKGROUND
  • 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.

    PMID: 11547739BACKGROUND
  • 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.

    PMID: 9563703BACKGROUND
  • 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.

    PMID: 9806033BACKGROUND

MeSH Terms

Conditions

HIV InfectionsHepatitis CHIV Seropositivity

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Susan Schuval

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2002

First Posted

May 15, 2002

Study Completion

July 1, 2003

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations