NCT00002284

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

February 1, 1995

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Lymphoma, Non-HodgkinHIV Infections

Keywords

Lymphoma, Large-CellAcquired Immunodeficiency SyndromeAIDS-Related ComplexZidovudineBone Marrow Transplantation

Interventions

ZidovudineDRUG

Eligibility Criteria

Age12 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hemapheresis Treatment Ctr

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinHIV InfectionsDendritic Cell Sarcoma, InterdigitatingAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Zidovudine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesHistiocytic Disorders, MalignantHistiocytosisSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1995-02

Locations

US(1)