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


N/A
N/A
N/A
Not Enrolling
Both
Hemophilia

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Trial Information

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


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..

Inclusion 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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Michael Dean, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

999902173

NCT ID:

NCT00340548

Start Date:

March 2002

Completion Date:

Related Keywords:

  • Hemophilia
  • Genotyping
  • Polymorphisms
  • Co-Infection
  • Chemokines
  • Associations
  • HIV
  • HCV
  • Hepatitis C
  • Hemophilia
  • Hemophilia A

Name

Location

University of IowaIowa City, Iowa  52242
University of OklahomaOklahoma City, Oklahoma  73190
Wayne State University Hutzel HospitalDetroit, Michigan  48201
University of California, San DiegoLa Jolla, California  92037-1709
NCI Frederick Cancer Research CenterFrederick, Maryland  21702-1201
University of NebraskaOmaha, Nebraska  68198
Mt. Sinai Medical CenterNew York, New York  10029
Cornell UniversityNew York, New York  10021
Childrens Hospital, Los AngelesLos Angeles, California  90054-0700
St. Vincent Hospital & Health Care CenterIndianapolis, Indiana  46260
Tulane UniversityNew Orleans, Louisiana  70112-2699
Childrens Mercy HospitalKansas City, Missouri  
Milton Hershey Medical CenterHershey, Pennsylvania  17033-2390
University of Texas, HoustonHouston, Texas  77225
University of Texas, San AntonioSan Antonio, Texas  78229-3900