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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: HIV Infections; Lymphoma, Non-Hodgkin

Treatments: Drug: Zidovudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002284

014A

006

Details and patient eligibility

About

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.

Sex: All

Ages: 12 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.