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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00340548 |
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 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..
Condition |
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Hemophilia |
Study Type: | Observational |
Official Title: | Host Genetic Factors Influencing HIV1 and HCV Viral Loads and AIDS Clinical Progression in a Hemophilia Cohort (HGDS-3) |
Estimated Enrollment: | 333 |
Study Start Date: | March 2002 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
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 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..
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
The current Study will involve analysis of existing samples (DNA, serum, cells, plasma) and data. The entire set of 333 subjects in the HGDS cohort will be analyzed.
EXCLUSION CRITERIA:
No subjects will be excluded from the HGDS cohort.
United States, California | |
University of California, San Diego | |
La Jolla, California, United States, 92093-0603 | |
Childrens Hospital, Los Angeles | |
Los Angeles, California, United States, 90054-0700 | |
United States, Indiana | |
St. Vincent Hospital & Health Care Center | |
Indianapolis, Indiana, United States, 46260 | |
United States, Iowa | |
University of Iowa | |
Iowa City, Iowa, United States, 52242-1101 | |
United States, Louisiana | |
Tulane University | |
New Orleans, Louisiana, United States, 70112-2699 | |
United States, Maryland | |
NCI Frederick Cancer Research Center | |
Frederick, Maryland, United States, 21702-1201 | |
United States, Michigan | |
Wayne State University Hutzel Hospital | |
Detroit, Michigan, United States, 48201 | |
United States, Missouri | |
Childrens Mercy Hospital | |
Kansas City, Missouri, United States | |
United States, Nebraska | |
University of Nebraska | |
Omaha, Nebraska, United States, 68198-7830 | |
United States, New York | |
Cornell University | |
New York, New York, United States, 10021-4872 | |
Mt. Sinai Medical Center | |
New York, New York, United States, 10029-0574 | |
United States, Oklahoma | |
University of Oklahoma | |
Oklahoma City, Oklahoma, United States | |
United States, Pennsylvania | |
Milton Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033-2390 | |
United States, Texas | |
University of Texas, San Antonio | |
San Antonio, Texas, United States, 78229-3900 | |
University of Texas, Houston | |
Houston, Texas, United States, 77225 |
Study ID Numbers: | 999902173, 02-C-N173 |
Study First Received: | June 19, 2006 |
Last Updated: | August 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00340548 History of Changes |
Health Authority: | United States: Federal Government |
Genotyping Polymorphisms Co-Infections Chemokines Associations |
HIV HCV Hepatitis C Hemophilia Co-Infection |
Hepatitis Hemorrhagic Disorders Genetic Diseases, Inborn Hematologic Diseases HIV Infections Blood Coagulation Disorders |
Hemophilia A Acquired Immunodeficiency Syndrome Disease Progression Hepatitis C Hemostatic Disorders |
Hemorrhagic Disorders Blood Coagulation Disorders, Inherited Genetic Diseases, Inborn Coagulation Protein Disorders |
Hematologic Diseases Blood Coagulation Disorders Hemophilia A |