Host Genetic Factors Influencing HIV1 and HCV Viral Loads and AIDS Clinical Progression in a Hemophilia Cohort (HGDS-3)
NCT ID: NCT00340548
Last Updated: 2020-01-13
Study Results
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Basic Information
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TERMINATED
333 participants
OBSERVATIONAL
2002-04-09
2020-01-09
Brief Summary
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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 NIH/NICHD for the period 9/25/01 through 8/31/2005.
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 3/89 and 6/90. The final observation of the cohort (follow-up 16) was concluded during 7/98. 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 HGDS/LGD 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..
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Detailed Description
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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 NIH/NICHD for the period 9/25/01 through 8/31/2005.
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 3/89 and 6/90. The final observation of the cohort (follow-up 16) was concluded during 7/98. 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 HGDS/LGD 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..
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
4 Years
100 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Daniel W McVicar, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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University of California, San Diego
La Jolla, California, United States
Childrens Hospital, Los Angeles
Los Angeles, California, United States
St. Vincent Hospital & Health Care Center
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Tulane University
New Orleans, Louisiana, United States
NCI Frederick Cancer Research Center
Frederick, Maryland, United States
Wayne State University Hutzel Hospital
Detroit, Michigan, United States
Childrens Mercy Hospital
Kansas City, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Cornell University
New York, New York, United States
Mt. Sinai Medical Center
New York, New York, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Milton Hershey Medical Center
Hershey, Pennsylvania, United States
University of Texas, Houston
Houston, Texas, United States
University of Texas, San Antonio
San Antonio, Texas, United States
Countries
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References
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Dean M, Carrington M, Winkler C, Huttley GA, Smith MW, Allikmets R, Goedert JJ, Buchbinder SP, Vittinghoff E, Gomperts E, Donfield S, Vlahov D, Kaslow R, Saah A, Rinaldo C, Detels R, O'Brien SJ. Genetic restriction of HIV-1 infection and progression to AIDS by a deletion allele of the CKR5 structural gene. Hemophilia Growth and Development Study, Multicenter AIDS Cohort Study, Multicenter Hemophilia Cohort Study, San Francisco City Cohort, ALIVE Study. Science. 1996 Sep 27;273(5283):1856-62. doi: 10.1126/science.273.5283.1856.
Daar ES, Lynn H, Donfield S, Gomperts E, Hilgartner MW, Hoots WK, Chernoff D, Arkin S, Wong WY, Winkler CA; Hemophilia Growth and Development Study. Relation between HIV-1 and hepatitis C viral load in patients with hemophilia. J Acquir Immune Defic Syndr. 2001 Apr 15;26(5):466-72. doi: 10.1097/00126334-200104150-00011.
Daar ES, Lynn H, Donfield S, Gomperts E, O'Brien SJ, Hilgartner MW, Hoots WK, Chernoff D, Arkin S, Wong WY, Winkler CA; Hemophilia Growth and Development Study. Hepatitis C virus load is associated with human immunodeficiency virus type 1 disease progression in hemophiliacs. J Infect Dis. 2001 Feb 15;183(4):589-95. doi: 10.1086/318539. Epub 2001 Jan 12.
Hilgartner MW, Donfield SM, Willoughby A, Contant CF Jr, Evatt BL, Gomperts ED, Hoots WK, Jason J, Loveland KA, McKinlay SM, et al. Hemophilia growth and development study. Design, methods, and entry data. Am J Pediatr Hematol Oncol. 1993 May;15(2):208-18. doi: 10.1097/00043426-199305000-00009.
Other Identifiers
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02-C-N173
Identifier Type: -
Identifier Source: secondary_id
999902173
Identifier Type: -
Identifier Source: org_study_id
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