HIV InfectionsNCT00000852
A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection
A study testing Allogeneic lymphocyte transfer in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
To examine, in HIV-infected patients, the safety of allogeneic lymphocyte transfer (i.e., infusion of white blood cells taken from an HIV-negative parent, sibling, or adult offspring who has a compatible blood type). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Allogeneic lymphocyte transfer
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Concurrent Medication:
- Required:
- Stable antiretroviral therapy.
- Allowed:
- Maintenance therapy for a controlled opportunistic infection.
- Patients must have:
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- HIV infection.
- CD4 count 50-200 cells/mm3.
- No ongoing major opportunistic infections.
- Been on stable antiretroviral therapy for the past 2 months.
- Tonsils present.
- Life expectancy greater than 6 months.
- An HLA-single haplotype matched, single haplotype mismatched parent, sibling, or adult offspring who is ABO, Rh compatible to serve as an HIV-negative lymphocyte donor.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Lymphoma or other malignancy requiring chemotherapy.
- Bleeding disorder that would preclude a tonsillar biopsy.
- Antibody on donor/recipient lymphocyte reactive antibody assay.
- Donors with the following symptoms or conditions are excluded:
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- Medical condition that would endanger health of donor or recipient.
- Failure to meet established donor standards on blood screening tests.
- CMV seropositivity if the patient (recipient) is CMV seronegative.
- Pregnancy.
- Concurrent Medication:
- Excluded:
- GM-CSF or G-CSF.
- Any investigational drug.
- Immunomodulators (such as interferon, steroids, topical corticosteroids, thalidomide, pentoxifylline, IL-2).
- Nonsteroidal anti-inflammatory drugs.
- Aspirin.
- Prior Treatment:
- Excluded:
- Blood transfusion within the past 2 months.
- Required:
- Stable antiretroviral therapy for at least 2 months prior to study entry.
- Active substance abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
About this study
To examine, in HIV-infected patients, the safety of allogeneic lymphocyte transfer (i.e., infusion of white blood cells taken from an HIV-negative parent, sibling, or adult offspring who has a compatible blood type). To measure the distribution and survival of allogeneic lymphocytes in the circulation of HIV-infected patients, and to determine whether their infusion results in enhanced immunity. To determine whether enhanced immunity is passively transferred or actively induced.
There is evidence that periodic infusion of allogeneic lymphocytes obtained from the peripheral blood of HLA-matched HIV-1 seronegative siblings of patients with AIDS can, in some instances, restore the number of circulating CD4+ lymphocytes. However, more controlled studies are needed to better quantitate the immunologic reconstitution seen with this type of therapy.
Read the detailed description
There is evidence that periodic infusion of allogeneic lymphocytes obtained from the peripheral blood of HLA-matched HIV-1 seronegative siblings of patients with AIDS can, in some instances, restore the number of circulating CD4+ lymphocytes. However, more controlled studies are needed to better quantitate the immunologic reconstitution seen with this type of therapy.
Lymphocytes obtained by leukapheresis from a healthy, HIV-negative parent, sibling, or adult offspring of the HIV-infected patient are infused at day 0 and at weeks 4 and 8. A small portion of the lymphocytes obtained at day 0 will be radiolabeled prior to infusion, and two total body scans will be performed. Patients also undergo two tonsillar biopsies. Patients are followed weekly for 16 weeks, then by telephone periodically for 3 years (at 1 year, 2 years, 2.5 years, and 3 years).
- Conditions
- HIV Infections
- Being tested
- Allogeneic lymphocyte transfer
- Keywords
- T-Lymphocytes, Acquired Immunodeficiency Syndrome, Transplantation, Homologous, Immunotherapy, Adoptive
- 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.
Allogeneic lymphocyte transferProcedure or surgery
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Enrolment
- 12 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Lederman M, Study chairLee E, Study chairDeyton L, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000852
- Sponsor's protocol ID
- DATRI 016
- Status last verified
- Nov 1998
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Volunteers sought for HIV treatment study. NIAID AIDS Agenda. 1996 Sep:3.
PubMed 11363923
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 of Allogeneic Lymphocyte Transfer in HIV Infection
- ClinicalTrials.gov ID
- NCT00000852
- Acronym / sponsor ID
- DATRI 016
- Conditions
- HIV Infections
- Keywords
- T-Lymphocytes, Acquired Immunodeficiency Syndrome, Transplantation, Homologous, Immunotherapy, Adoptive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- 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 examine, in HIV-infected patients, the safety of allogeneic lymphocyte transfer (i.e., infusion of white blood cells taken from an HIV-negative parent, sibling, or adult offspring who has a compatible blood type). To measure the distribution and survival of allogeneic lymphocytes in the circulation of HIV-infected patients, and to determine whether their infusion results in enhanced immunity. To determine whether enhanced immunity is passively transferred or actively induced.
There is evidence that periodic infusion of allogeneic lymphocytes obtained from the peripheral blood of HLA-matched HIV-1 seronegative siblings of patients with AIDS can, in some instances, restore the number of circulating CD4+ lymphocytes. However, more controlled studies are needed to better quantitate the immunologic reconstitution seen with this type of therapy.
Detailed description
There is evidence that periodic infusion of allogeneic lymphocytes obtained from the peripheral blood of HLA-matched HIV-1 seronegative siblings of patients with AIDS can, in some instances, restore the number of circulating CD4+ lymphocytes. However, more controlled studies are needed to better quantitate the immunologic reconstitution seen with this type of therapy.
Lymphocytes obtained by leukapheresis from a healthy, HIV-negative parent, sibling, or adult offspring of the HIV-infected patient are infused at day 0 and at weeks 4 and 8. A small portion of the lymphocytes obtained at day 0 will be radiolabeled prior to infusion, and two total body scans will be performed. Patients also undergo two tonsillar biopsies. Patients are followed weekly for 16 weeks, then by telephone periodically for 3 years (at 1 year, 2 years, 2.5 years, and 3 years).
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Stable antiretroviral therapy.
- Maintenance therapy for a controlled opportunistic infection.
- HIV infection.
- CD4 count 50-200 cells/mm3.
- No ongoing major opportunistic infections.
Key exclusion criteria (23 listed)
- Lymphoma or other malignancy requiring chemotherapy.
- Bleeding disorder that would preclude a tonsillar biopsy.
- Antibody on donor/recipient lymphocyte reactive antibody assay.
- Medical condition that would endanger health of donor or recipient.
- Failure to meet established donor standards on blood screening tests.
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 |
|---|---|---|
| Allogeneic lymphocyte transfer | Procedure or surgery | – |
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.
- Background: PubMed 11363923Volunteers sought for HIV treatment study. NIAID AIDS Agenda. 1996 Sep:3.
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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.
Lederman M study chair
Lee E study chair
Deyton L study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allogeneic lymphocyte transfer in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 13 inclusion and 23 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?
On the ClinicalTrials.gov record for NCT00000852, which also lists 1 linked publication.
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.