Lymphoma, Non-HodgkinNCT00002284
A Study of Azidothymidine (AZT) in the Treatment of HIV Infection in Patients Receiving a Bone Marrow Transplant
A study testing Zidovudine in people with Lymphoma, Non-Hodgkin and HIV Infections, run by Glaxo Wellcome at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Lymphoma, Non-Hodgkin, HIV Infections
- What is being tested?
- Zidovudine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Hemapheresis Treatment Ctr
Baltimore, Maryland, 21205
About this study
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
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.
- Conditions
- Lymphoma, Non-Hodgkin, HIV Infections
- Being tested
- Zidovudine
- Keywords
- Lymphoma, Large-Cell, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Bone Marrow Transplantation
- Medical subject headings
- Lymphoma, Non-Hodgkin, HIV Infections, Dendritic Cell Sarcoma, Interdigitating, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZidovudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002284
- Sponsor's protocol ID
- 014A
- Other IDs
- 006
- Status last verified
- Feb 1995
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00002284
- Acronym / sponsor ID
- 014A
- Conditions
- Lymphoma, Non-Hodgkin, HIV Infections
- Keywords
- Lymphoma, Large-Cell, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Bone Marrow Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Glaxo WellcomeIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Patients with current life-threatening infection at time of transplant that would preclude a transplant are excluded.
- Other anti-retroviral agents.
- Patients with current life-threatening infection at time of transplant that would preclude a transplant are excluded.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zidovudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zidovudine in people with Lymphoma, Non-Hodgkin and HIV Infections, run by Glaxo Wellcome at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.