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

This study has been completed.

Sponsored by: Glaxo Wellcome
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002284
  Purpose

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 Intervention
Lymphoma, Non-Hodgkin
HIV Infections
Drug: Zidovudine

MedlinePlus related topics:   AIDS    Bone Marrow Transplantation    Lymphoma   

ChemIDplus related topics:   Zidovudine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Dose Comparison
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
  Eligibility
Ages Eligible for Study:   12 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002284

Locations
United States, Maryland
Johns Hopkins Hemapheresis Treatment Ctr    
      Baltimore, Maryland, United States, 21205

Sponsors and Collaborators
Glaxo Wellcome
  More Information


Study ID Numbers:   014A, 006
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002284
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Lymphoma, Large-Cell  
Acquired Immunodeficiency Syndrome  
AIDS-Related Complex  
Zidovudine  
Bone Marrow Transplantation  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Immunoproliferative Disorders
Acquired Immunodeficiency Syndrome
Zidovudine
AIDS-Related Complex
Immunologic Deficiency Syndromes
Lymphoma, large-cell
Virus Diseases
Lymphatic Diseases
HIV Infections
Sexually Transmitted Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Retroviridae Infections

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Neoplasms by Histologic Type
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Neoplasms
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 16, 2008




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