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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Zidovudine

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Lymphoma, Large-Cell, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Bone Marrow Transplantation

Eligibility Criteria

12 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Johns Hopkins Hemapheresis Treatment Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002284

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Glaxo Wellcome

1. Study Identification

Unique Protocol Identification Number

NCT00002284

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 1995

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Glaxo Wellcome

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Non-Hodgkin, HIV Infections

Keywords

Lymphoma, Large-Cell, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Bone Marrow Transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Zidovudine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

Johns Hopkins Hemapheresis Treatment Ctr

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Lymphoma, Non-Hodgkin, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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