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A Study of Azidothymidine (AZT) in the Treatment of HIV Infection in Patients Receiving a Bone Marrow Transplant

Sponsor
Glaxo Wellcome (Industry)
Overall Status
Completed
CT.gov ID
NCT00002284
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

To determine whether zidovudine (AZT) in conjunction with bone marrow transplantation prevents the reinfection of donor hematopoietic/lymphoid cells in patients with positive HTLV III antibody and large cell/diffuse histiocytic lymphoma. Patients who are candidates will be evaluated for HTLV III activity and drug levels.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Pilot Study To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients Receiving a Bone Marrow Transplant

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Exclusion Criteria

    Co-existing Condition:

    Patients with current life-threatening infection at time of transplant that would preclude a transplant are excluded.

    Concurrent Medication:
    Excluded:
    • Other anti-retroviral agents.

    Patients with current life-threatening infection at time of transplant that would preclude a transplant are excluded.

    Patients must be:

    • HTLV III antibody positive by ELISA or Western blot or HTLV III viremia.

    • At high mortal risk with a diagnosis of AIDS or AIDS Related Complex (ARC).

    • Also patient must fall into one of the following categories:

    • Have an HIV seronegative identical twin to serve as a bone marrow donor.

    • Have documentation of large cell/diffuse histiocytic lymphoma/DPDL.

    • Be a good risk candidate for bone marrow transplant.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins Hemapheresis Treatment Ctr Baltimore Maryland United States 21205

    Sponsors and Collaborators

    • Glaxo Wellcome

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002284
    Other Study ID Numbers:
    • 014A
    • 006
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Feb 1, 1995
    Keywords provided by , ,
    Lymphoma, Large-Cell
    Acquired Immunodeficiency Syndrome
    AIDS-Related Complex
    Zidovudine
    Bone Marrow Transplantation
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    HIV Infections
    Acquired Immunodeficiency Syndrome
    Lymphoma, Non-Hodgkin
    Zidovudine

    Study Results

    No Results Posted as of Jun 24, 2005