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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | November 2, 1999 | ||||||||||||
| Last Updated Date | June 23, 2005 | ||||||||||||
| Start Date ICMJE | |||||||||||||
| Primary Completion Date | |||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||
| Change History | Complete list of historical versions of study NCT00000852 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection | ||||||||||||
| Official Title ICMJE | A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection | ||||||||||||
| Brief 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). 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. |
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| 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). |
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| Study Phase | |||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Treatment | ||||||||||||
| Condition ICMJE | HIV Infections | ||||||||||||
| Intervention ICMJE | Procedure: Allogeneic lymphocyte transfer | ||||||||||||
| Study Arms / Comparison Groups | |||||||||||||
| Publications * | [No authors listed] Volunteers sought for HIV treatment study. NIAID AIDS Agenda. 1996 Sep;:3. No abstract available. | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 12 | ||||||||||||
| Completion Date | |||||||||||||
| Primary Completion Date | |||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Required:
Allowed:
Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:
Donors with the following symptoms or conditions are excluded:
Concurrent Medication: Excluded:
Prior Treatment: Excluded:
Required:
Active substance abuse. |
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| Gender | Both | ||||||||||||
| Ages | 18 Years to 50 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00000852 | ||||||||||||
| Responsible Party | |||||||||||||
| Study ID Numbers ICMJE | DATRI 016 | ||||||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||
| Verification Date | November 1998 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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