HIV InfectionsNCT00002285
A Study of Zidovudine and T Lymphocyte Transfer in the Treatment of HIV Type III in Patients With AIDS
A study testing Zidovudine in people with HIV Infections, run by Glaxo Wellcome at 1 site in United States.
Trial summary
To determine the safety and efficacy of zidovudine (AZT) treatment combined with syngeneic or HLA identical allogeneic lymphocyte transfer in the presence of interleukin 2 (IL-2) as a treatment for AIDS. Patients with documented HIV viremia will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Co-existing Condition:
- Patients with the following are excluded:
- Lymphoma. Active central nervous system (CNS) infection by bacteria, varicella zoster virus, herpes simplex virus, or Cryptococcus neoformans. Any prior CNS infection due to Toxoplasma gondii. Any active life-threatening infection including Pneumocystis carinii pneumonia (PCP) (if prior PCP then pre-PCP arterial PO2 must be above 80), disseminated cryptococcosis (if there was a prior cryptococcosis infection the patient must have had a negative blood and cerebrospinal fluid (CSF) culture taken more than 6 weeks after the last antifungal therapy).
- Any prior mycobacterium avium-intracellulare isolation.
- Patients with the following conditions are excluded:
- Lymphoma. Active central nervous system (CNS) infection by bacteria, varicella zoster virus, herpes simplex virus, or Cryptococcus neoformans. Any prior CNS infection due to Toxoplasma gondii. Any active life-threatening infection including Pneumocystis carinii pneumonia (PCP) (if prior PCP then pre-PCP arterial PO2 must be above 80), disseminated cryptococcosis (if there was a prior cryptococcosis infection the patient must have had a negative blood and cerebrospinal fluid (CSF) culture taken more than 6 weeks after the last antifungal therapy).
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- Any prior mycobacterium avium-intracellulare isolation. Patients accepted for allogenic cell transfer must meet the CDC criteria for AIDS. Those patients who meet the criteria only because of Kaposi's sarcoma must also have a history of generalized lymphadenopathy (CDC category III), neurologic disease (CDC category IV-B), or constitutional disease (CDC category IV-A). Patients may be accepted for syngeneic cell transfer even if they have not met the CDC AIDS criteria, provided they have had constitutional disease (CDC category IV-A) or a specified non-AIDS defining secondary infection (CDC category IV-C2).
- Patients must have a positive blood culture for the AIDS virus before the beginning of therapy.
- Patients must be skin test negative for PPD. Patients must have a life expectancy of at least 6 months and a Karnofsky status of 60 or above.
- Patients must sign an informed consent agreement. From eligible patients precedence will be given to those with identical twin donors, then to Minnesota residents. The first patient must have an identical twin donor. Among eligible Minnesota patients without identical twin donors, the order of enrollment will be determined by overall good health, the presence of Kaposi's sarcoma (which permits monitoring of response by measuring lesions) and/or the presence of cytomegalovirus (CMV) viremia (which permits monitoring of response by remission of CMV viremia).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, 27709
About this study
Official title: A Phase I/II Pilot Trial To Evaluate Zidovudine (AZT) and T Lymphocyte Transfer in the Treatment of Human Immunodeficiency Virus Type-III (HIV) Infection in AIDS Patients
To determine the safety and efficacy of zidovudine (AZT) treatment combined with syngeneic or HLA identical allogeneic lymphocyte transfer in the presence of interleukin 2 (IL-2) as a treatment for AIDS. Patients with documented HIV viremia will be evaluated. Effects on virus replication, immune function, and clinical condition will be monitored with periodic virus cultures, estimates of lymphocyte type and numbers, cell surface markers, in vitro lymphocyte responses and frequent clinical evaluations.
- Conditions
- HIV Infections
- Being tested
- Zidovudine
- Keywords
- Virus Replication, Pilot Projects, Immune Tolerance, Lymphocytes, Drug Evaluation, Combined Modality Therapy, Acquired Immunodeficiency Syndrome, Transplantation, Homologous, Zidovudine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
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 HIV InfectionsStudies 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
- NCT00002285
- Sponsor's protocol ID
- 014B
- Other IDs
- 27433-10
- 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 Phase I/II Pilot Trial To Evaluate Zidovudine (AZT) and T Lymphocyte Transfer in the Treatment of Human Immunodeficiency Virus Type-III (HIV) Infection in AIDS Patients
- ClinicalTrials.gov ID
- NCT00002285
- Acronym / sponsor ID
- 014B
- Conditions
- HIV Infections
- Keywords
- Virus Replication, Pilot Projects, Immune Tolerance, Lymphocytes, Drug Evaluation, Combined Modality Therapy, Acquired Immunodeficiency Syndrome, Transplantation, Homologous
- 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 the safety and efficacy of zidovudine (AZT) treatment combined with syngeneic or HLA identical allogeneic lymphocyte transfer in the presence of interleukin 2 (IL-2) as a treatment for AIDS. Patients with documented HIV viremia will be evaluated. Effects on virus replication, immune function, and clinical condition will be monitored with periodic virus cultures, estimates of lymphocyte type and numbers, cell surface markers, in vitro lymphocyte responses and frequent clinical evaluations.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Lymphoma. Active central nervous system (CNS) infection by bacteria, varicella zoster virus, herpes simplex virus, or Cryptococcus neoformans. Any prior CNS infection due to Toxoplasma gondii. Any active life-threatening infection including Pneumocystis carinii pneumonia (PCP) (if prior PCP then pre-PCP arterial PO2 must be above 80), disseminated cryptococcosis (if there was a prior cryptococcosis infection the patient must have had a negative blood and cerebrospinal fluid (CSF) culture taken more than 6 weeks after the last antifungal therapy).
- Any prior mycobacterium avium-intracellulare isolation.
- Lymphoma. Active central nervous system (CNS) infection by bacteria, varicella zoster virus, herpes simplex virus, or Cryptococcus neoformans. Any prior CNS infection due to Toxoplasma gondii. Any active life-threatening infection including Pneumocystis carinii pneumonia (PCP) (if prior PCP then pre-PCP arterial PO2 must be above 80), disseminated cryptococcosis (if there was a prior cryptococcosis infection the patient must have had a negative blood and cerebrospinal fluid (CSF) culture taken more than 6 weeks after the last antifungal therapy).
- Any prior mycobacterium avium-intracellulare isolation. Patients accepted for allogenic cell transfer must meet the CDC criteria for AIDS. Those patients who meet the criteria only because of Kaposi's sarcoma must also have a history of generalized lymphadenopathy (CDC category III), neurologic disease (CDC category IV-B), or constitutional disease (CDC category IV-A). Patients may be accepted for syngeneic cell transfer even if they have not met the CDC AIDS criteria, provided they have had constitutional disease (CDC category IV-A) or a specified non-AIDS defining secondary infection (CDC category IV-C2).
- Patients must have a positive blood culture for the AIDS virus before the beginning of therapy.
Key exclusion criteria (0 listed)
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 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 10 inclusion and 0 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.