HIV InfectionsNCT00037076
Prevalence of Hepatitis C Virus Infection in HIV-Infected Children
An observational study of HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 39 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 20 years
- Conditions the study is for
- HIV Infections, Hepatitis C
- How many people
- 600 participants
- Where
- 39 sitesin 2 countries
- Study dates
- Start not givento Jul 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
39 sites in 2 countries.
39 sites in 2 countries
United States37 sites
Med College of Georgia
Augusta, Georgia, 30912
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 21287-4933
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
Children's Hospital at SUNY Downstate
Brooklyn, New York, 11203
Univ of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608
The Univ of Chicago Children's Hosp
Chicago, Illinois, 60612
University of Illinois
Chicago, Illinois, 60612
The Med Ctr Inc
Columbus, Georgia, 31901
Children's Med Ctr of Dallas
Dallas, Texas, 75235
Children's Hosp of Denver
Denver, Colorado, 802181088
Children's Hosp of Michigan
Detroit, Michigan, 48201
Duke University (Pediatric)
Durham, North Carolina, 27705
Connecticut Childrens Med Ctr (Pediatric)
Farmington, Connecticut, 06030
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
Univ of Miami (Pediatric)
Miami, Florida, 33161
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 372322581
Yale Univ Med School
New Haven, Connecticut, 06504
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
Mount Sinai Med Ctr
New York, New York, 10029
Columbia Presbyterian Med Ctr
New York, New York, 10032
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
Children's Hosp of Oakland
Oakland, California, 94609-1809
Childrens Hosp of Philadelphia
Philadelphia, Pennsylvania, 19104
St. Christopher's Hosp for Children, Philadelphia
Philadelphia, Pennsylvania, 19134
Phoenix Childrens Hosp
Phoenix, Arizona, 85006
Univ of Rochester Med Ctr
Rochester, New York, 146420001
Univ of California, San Diego
San Diego, California, 92103
UCSF, Moffitt Hospital (Pediatric)
San Francisco, California, 94143
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
Puerto Rico2 sites
Univ. of Puerto Rico, U. Children's Hospital AIDS
San Juan, 00936-5067
San Juan City Hosp
San Juan, 009367344
About this study
Official title: Hepatitis C Prevalence in Perinatally Infected HIV-Positive Children Enrolled in PACTG 219C
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).
Read the 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.
- 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
- Medical subject headings
- HIV Infections, Hepatitis C, HIV Seropositivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2002 (estimated)
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 600 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Susan Schuval, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037076
- Sponsor's protocol ID
- PACTG P1028S
- Other IDs
- 11657
- Status last verified
- Oct 2012
- First submitted
- 14 May 2002
- Last updated
- 31 Oct 2012
- Results posted
- No
Publications
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.
PubMed 11176560Tillmann 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.
PubMed 11547740Xiang 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.
PubMed 11547739Thomas 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.
PubMed 9563703Papaevangelou 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.
PubMed 9806033
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Prevalence in Perinatally Infected HIV-Positive Children Enrolled in PACTG 219C
- ClinicalTrials.gov ID
- NCT00037076
- Acronym / sponsor ID
- PACTG P1028S
- Conditions
- HIV Infections, Hepatitis C
- Keywords
- HIV Seropositivity, Hepatitis C, Polymerase Chain Reaction, RNA, Viral, Prevalence, Disease Transmission, Vertical, Hepacivirus, Enzyme Immunoassay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study completion
- Jul 2003 (actual)
- First posted
- 15 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 1 year to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Have hemophilia.
- Contracted HIV through a route other than from the mother around the time of birth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
- Background: PubMed 11176560Tajiri 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.
- Background: PubMed 11547740Tillmann 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.
- Background: PubMed 11547739Xiang 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.
- Background: PubMed 9563703Thomas 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.
- Background: PubMed 9806033Papaevangelou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Schuval study chair
39 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Hepatitis C, run by National Institute of Allergy and Infectious Diseases (NIAID) at 39 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00037076, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2012.