Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340548
Status:
TERMINATED
Last Update Posted:
2020-01-13
First Post:
2006-06-19
Brief Title:
Host Genetic Factors Influencing HIV1 and HCV Viral Loads and AIDS Clinical Progression in a Hemophilia Cohort HGDS-3
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Host Genetic Factors Influencing HIV1 and HCV Viral Loads and AIDS Clinical Progression in a Hemophilia Cohort HGDS-3
Status:
TERMINATED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lapse in IRB review
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Over 80 of the hemophiliac population who became infected with HIV prior to 1985 are also co-infected with HCV Thus hemophiliacs represent an important population for studies of the natural history of these chronic viral infections
Moreover the high rate of co-infection makes it an ideal group for assessing the interaction between the viruses and the relationship between viral specific immune responses and clinical progression
Although the hemophiliac poulation is unique co-infection by these chronic viral pathogens is becoming increasingly common particularly amongst intravenous drug users who account for approximately 25 of the HIV-1 epidemic in the United States
Objectives
The aim of this study is to determine if polymorphism in the promoter region of TH1 and Th2 cytokines are associated with 1 intracellular cytokines levels in CD4 Tcells 2 Human Immunodeficiency Virus HIV and Hepatitis C virus HCV viral loads and 3 clinical progression of HIV1 to AIDS in hemophiliacs
Eligibility
The current proposal will investigate host genetic factors related to HIV-1 and HCV immunopathogenesis by studying children and adolescents enrolled in the Hemophilia Growth and Development Study HGDS
Design
This study is in collaboration with the principle investigators of the Hemophilia Growth and Development Study HGDS as part of a grant Pathogenesis of HIV and HCV in Hemophilia HGDS-3 with funding support by NIHNICHD for the period 92501 through 8312005
This multicenter United States study represents a well-characterized prospectively followed cohort of HCV-infected hemophiliacs of whom 207 are HIV-1 co-infected
Enrollment of the hemophiliac cohort was completed between 389 and 690 The final observation of the cohort follow-up 16 was concluded during 798 No new samples or clinical data will be collected on this population
The LGD plays two roles in this project 1 an administrative role overseeing the withdrawal handling and transport of samples from the HGDSLGD and central repositories at the NCI-Frederick and 2 a scientific role continuing investigations to determine the role of host genetic factors in Th1 and Th2 immune response and regulation of HCV and HIV viral replication
Over 80 of the hemophiliac population who became infected with HIV prior to 1985 are also co-infected with HCV Thus hemophiliacs represent an important population for studies of the natural history of these chronic viral infections
Moreover the high rate of co-infection makes it an ideal group for assessing the interaction between the viruses and the relationship between viral specific immune responses and clinical progression
Although the hemophiliac poulation is unique co-infection by these chronic viral pathogens is becoming increasingly common particularly amongst intravenous drug users who account for approximately 25 of the HIV-1 epidemic in the United States
Objectives
The aim of this study is to determine if polymorphism in the promoter region of TH1 and Th2 cytokines are associated with 1 intracellular cytokines levels in CD4 Tcells 2 Human Immunodeficiency Virus HIV and Hepatitis C virus HCV viral loads and 3 clinical progression of HIV1 to AIDS in hemophiliacs
Eligibility
The current proposal will investigate host genetic factors related to HIV-1 and HCV immunopathogenesis by studying children and adolescents enrolled in the Hemophilia Growth and Development Study HGDS
Design
This study is in collaboration with the principle investigators of the Hemophilia Growth and Development Study HGDS as part of a grant Pathogenesis of HIV and HCV in Hemophilia HGDS-3 with funding support by NIHNICHD for the period 92501 through 8312005
This multicenter United States study represents a well-characterized prospectively followed cohort of HCV-infected hemophiliacs of whom 207 are HIV-1 co-infected
Enrollment of the hemophiliac cohort was completed between 389 and 690 The final observation of the cohort follow-up 16 was concluded during 798 No new samples or clinical data will be collected on this population
The LGD plays two roles in this project 1 an administrative role overseeing the withdrawal handling and transport of samples from the HGDSLGD and central repositories at the NCI-Frederick and 2 a scientific role continuing investigations to determine the role of host genetic factors in Th1 and Th2 immune response and regulation of HCV and HIV viral replication
Detailed Description:
Background
Over 80 of the hemophiliac population who became infected with HIV prior to 1985 are also co-infected with HCV Thus hemophiliacs represent an important population for studies of the natural history of these chronic viral infections
Moreover the high rate of co-infection makes it an ideal group for assessing the interaction between the viruses and the relationship between viral specific immune responses and clinical progression
Although the hemophiliac poulation is unique co-infection by these chronic viral pathogens is becoming increasingly common particularly amongst intravenous drug users who account for approximately 25 of the HIV-1 epidemic in the United States
Objectives
The aim of this study is to determine if polymorphism in the promoter region of TH1 and Th2 cytokines are associated with 1 intracellular cytokines levels in CD4 Tcells 2 Human Immunodeficiency Virus HIV and Hepatitis C virus HCV viral loads and 3 clinical progression of HIV1 to AIDS in hemophiliacs
Eligibility
The current proposal will investigate host genetic factors related to HIV-1 and HCV immunopathogenesis by studying children and adolescents enrolled in the Hemophilia Growth and Development Study HGDS
Design
This study is in collaboration with the principle investigators of the Hemophilia Growth and Development Study HGDS as part of a grant Pathogenesis of HIV and HCV in Hemophilia HGDS-3 with funding support by NIHNICHD for the period 92501 through 8312005
This multicenter United States study represents a well-characterized prospectively followed cohort of HCV-infected hemophiliacs of whom 207 are HIV-1 co-infected
Enrollment of the hemophiliac cohort was completed between 389 and 690 The final observation of the cohort follow-up 16 was concluded during 798 No new samples or clinical data will be collected on this population
The LGD plays two roles in this project 1 an administrative role overseeing the withdrawal handling and transport of samples from the HGDSLGD and central repositories at the NCI-Frederick and 2 a scientific role continuing investigations to determine the role of host genetic factors in Th1 and Th2 immune response and regulation of HCV and HIV viral replication
Over 80 of the hemophiliac population who became infected with HIV prior to 1985 are also co-infected with HCV Thus hemophiliacs represent an important population for studies of the natural history of these chronic viral infections
Moreover the high rate of co-infection makes it an ideal group for assessing the interaction between the viruses and the relationship between viral specific immune responses and clinical progression
Although the hemophiliac poulation is unique co-infection by these chronic viral pathogens is becoming increasingly common particularly amongst intravenous drug users who account for approximately 25 of the HIV-1 epidemic in the United States
Objectives
The aim of this study is to determine if polymorphism in the promoter region of TH1 and Th2 cytokines are associated with 1 intracellular cytokines levels in CD4 Tcells 2 Human Immunodeficiency Virus HIV and Hepatitis C virus HCV viral loads and 3 clinical progression of HIV1 to AIDS in hemophiliacs
Eligibility
The current proposal will investigate host genetic factors related to HIV-1 and HCV immunopathogenesis by studying children and adolescents enrolled in the Hemophilia Growth and Development Study HGDS
Design
This study is in collaboration with the principle investigators of the Hemophilia Growth and Development Study HGDS as part of a grant Pathogenesis of HIV and HCV in Hemophilia HGDS-3 with funding support by NIHNICHD for the period 92501 through 8312005
This multicenter United States study represents a well-characterized prospectively followed cohort of HCV-infected hemophiliacs of whom 207 are HIV-1 co-infected
Enrollment of the hemophiliac cohort was completed between 389 and 690 The final observation of the cohort follow-up 16 was concluded during 798 No new samples or clinical data will be collected on this population
The LGD plays two roles in this project 1 an administrative role overseeing the withdrawal handling and transport of samples from the HGDSLGD and central repositories at the NCI-Frederick and 2 a scientific role continuing investigations to determine the role of host genetic factors in Th1 and Th2 immune response and regulation of HCV and HIV viral replication
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 |
|---|---|---|---|
| 02-C-N173 | None | None | None |