Host Genetic Factors Influencing HIV1 and HCV Viral Loads and AIDS Clinical Progression in a Hemophilia Cohort (HGDS-3)

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00340548
First received: June 19, 2006
Last updated: March 14, 2014
Last verified: March 2013
  Purpose

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
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)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 333
Study Start Date: March 2002
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 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..

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00340548

Locations
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, Houston
Houston, Texas, United States, 77225
University of Texas, San Antonio
San Antonio, Texas, United States, 78229-3900
Sponsors and Collaborators
Investigators
Principal Investigator: Michael Dean, Ph.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00340548     History of Changes
Other Study ID Numbers: 999902173, 02-C-N173
Study First Received: June 19, 2006
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Genotyping
Polymorphisms
Co-Infection
Chemokines
Associations
HIV
HCV
Hepatitis C
Hemophilia

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on April 14, 2014