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

NCT00340548 | Terminated

• 2 other identifiers: 99990217302-C-N173
• Study Type: observational
• Target: 333
• Locations: 1 country
• Sites: 15

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..

Conditions

Hemophilia; AIDS

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Receipt of 333 samples

  Annually

Eligibility Criteria

• Age: 4 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• No subjects will be excluded from the HGDS cohort.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (15)

University of California, San Diego

La Jolla, California, 92093-0603, United States

Location

Childrens Hospital, Los Angeles

Los Angeles, California, 90054-0700, United States

Location

St. Vincent Hospital & Health Care Center

Indianapolis, Indiana, 46260, United States

Location

University of Iowa

Iowa City, Iowa, 52242-1101, United States

Location

Tulane University

New Orleans, Louisiana, 70112-2699, United States

Location

NCI Frederick Cancer Research Center

Frederick, Maryland, 21702-1201, United States

Location

Wayne State University Hutzel Hospital

Detroit, Michigan, 48201, United States

Location

Childrens Mercy Hospital

Kansas City, Missouri, United States

Location

University of Nebraska

Omaha, Nebraska, 68198-7830, United States

Location

Cornell University

New York, New York, 10021-4872, United States

Location

Mt. Sinai Medical Center

New York, New York, 10029-0574, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, United States

Location

Milton Hershey Medical Center

Hershey, Pennsylvania, 17033-2390, United States

Location

University of Texas, Houston

Houston, Texas, 77225, United States

Location

University of Texas, San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Related Publications (4)

• 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.

  PMID: 8791590 BACKGROUND

• 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.

  PMID: 11391167 BACKGROUND

• 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.

  PMID: 11170984 BACKGROUND

• 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.

  PMID: 8498644 BACKGROUND

MeSH Terms

Conditions

Hemophilia A; Acquired Immunodeficiency Syndrome; Coinfection; Hepatitis C

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Daniel W McVicar, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: April 9, 2002
• Primary Completion: January 9, 2020
• Study Completion: January 9, 2020
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

US (15)