Prospective Study of HIV Infection in Hemophiliacs
Primary Purpose
Acquired Immunodeficiency Syndrome, HIV Infections, Blood Disease
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Acquired Immunodeficiency Syndrome
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005309
First Posted
May 25, 2000
Last Updated
December 12, 2018
Sponsor
Bloodworks
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005309
Brief Title
Prospective Study of HIV Infection in Hemophiliacs
Study Type
Observational
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 1990 (Actual)
Primary Completion Date
March 1995 (Actual)
Study Completion Date
March 1995 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bloodworks
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Immunodeficiency Syndrome, HIV Infections, Blood Disease, Hemophilia A, Hepatitis, Viral, Human, Blood Transfusion, Cytomegalovirus Infections
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Gjerset
Organizational Affiliation
Bloodworks
12. IPD Sharing Statement
Learn more about this trial
Prospective Study of HIV Infection in Hemophiliacs
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