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Prospective Study of HIV Infection in Hemophiliacs

This study has been completed.
Study NCT00005309.   Last updated on June 23, 2005.   Information provided by National Heart, Lung, and Blood Institute (NHLBI)

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Descriptive Information Fields
Brief Title  Prospective Study of HIV Infection in Hemophiliacs
Official Title 
Brief Summary

To examine mechanisms of individual differences in the progression of HIV infection in hemophiliacs.

Detailed Description

BACKGROUND:

In the late 1980s, hemophiliacs were transfused with a variety of blood products, including large amounts of cryoprecipitate. In comparison to other cohorts, hemophiliacs are CMV(-), resulting in a comparison group for the study of this virus as a potential cofactor. In contrast, non A, non-B hepatitis is common in comparison to other cohorts, and preliminary data prior to 1990 suggested that this chronic disease predisposes to more rapid progression of HIV infection.

DESIGN NARRATIVE:

Disease-free survival rates were determined in HIV-infected hemophiliacs. The effects of co-factors such as intensive transfusion, concomitant cytomegalovirus or chronic NANB hepatitis infection were ascertained. Host-virus interaction was assessed through the use of plasma cultures, specific antibody titers, and markers of immune changes detected by flow cytometry and immune function assays. The immunology of asymptomatic stable infection was investigated. The safety of volunteer donor blood products was determined in seronegative patients exposed to over 50,000 donors yearly and the risk of sexual transmission of HIV to spouses of seropositive patients was monitored.

Study Phase
Study Type  Observational
Study Design  Natural History
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Acquired Immunodeficiency Syndrome
HIV Infections
Blood Disease
Hemophilia A
Hepatitis, Viral, Human
Blood Transfusion
Cytomegalovirus Infections
Intervention 
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  July 1990
Completion Date March 1995
Eligibility Criteria 

No eligibility criteria

Gender Male
Ages
Accepts Healthy Volunteers No
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00005309
Organization ID 3012
Secondary IDs ††
Study Sponsor  National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ††
Investigators 
Investigator:     George Gjerset     Puget Sound Blood Center    
Information Provided By National Heart, Lung, and Blood Institute (NHLBI)
Verification Date March 2005
First Received Date  May 25, 2000
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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