Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037076
Status:
COMPLETED
Last Update Posted:
2012-10-31
First Post:
2002-05-14
Brief Title:
Prevalence of Hepatitis C Virus Infection in HIV-Infected Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Hepatitis C Prevalence in Perinatally Infected HIV-Positive Children Enrolled in PACTG 219C
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11657 | REGISTRY | DAIDS ES Registry Number | None |