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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
Bloodworks
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Acquired Immunodeficiency Syndrome

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    December 12, 2018
    Sponsor
    Bloodworks
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    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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