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

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Bone Marrow Transplantation Lymphoma

Drug Information available for: Zidovudine

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	014A, 006
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002284 History of Changes
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

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Communicable Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Lymphoma
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections

Anti-HIV Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Lymphatic Diseases
Neoplasms
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 27, 2009