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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Terminated

CT.gov ID

NCT00340548

Collaborator

(none)

333

Enrollment

Locations

213

Duration (Months)

22.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
Hemophilia AIDS

Detailed Description

Background:

Objectives:

Eligibility:

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.

Study Design

Study Type:

Observational

Actual Enrollment :

333 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Apr 9, 2002

Actual Primary Completion Date :

Jan 9, 2020

Actual Study Completion Date :

Jan 9, 2020

Outcome Measures

Primary Outcome Measures

Receipt of 333 samples [Annually]

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego	La Jolla	California	United States	92093-0603
2	Childrens Hospital, Los Angeles	Los Angeles	California	United States	90054-0700
3	St. Vincent Hospital & Health Care Center	Indianapolis	Indiana	United States	46260
4	University of Iowa	Iowa City	Iowa	United States	52242-1101
5	Tulane University	New Orleans	Louisiana	United States	70112-2699
6	NCI Frederick Cancer Research Center	Frederick	Maryland	United States	21702-1201
7	Wayne State University Hutzel Hospital	Detroit	Michigan	United States	48201
8	Childrens Mercy Hospital	Kansas City	Missouri	United States
9	University of Nebraska	Omaha	Nebraska	United States	68198-7830
10	Cornell University	New York	New York	United States	10021-4872
11	Mt. Sinai Medical Center	New York	New York	United States	10029-0574
12	University of Oklahoma	Oklahoma City	Oklahoma	United States
13	Milton Hershey Medical Center	Hershey	Pennsylvania	United States	17033-2390
14	University of Texas, Houston	Houston	Texas	United States	77225
15	University of Texas, San Antonio	San Antonio	Texas	United States	78229-3900