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

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002284

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: February 1995

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00002284 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of Azidothymidine (AZT) in the Treatment of HIV Infection in Patients Receiving a Bone Marrow Transplant
Official Title ^ICMJE	A Pilot Study To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients Receiving a Bone Marrow Transplant
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	Lymphoma, Non-Hodgkin HIV Infections
Intervention ^ICMJE	Drug: Zidovudine
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	12 Years to 50 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00002284
Other Study ID Numbers ^ICMJE	014A, 006
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Glaxo Wellcome
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	February 1995
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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