A Study of the Safety and Survival of the Adoptive Transfer of Genetically Marked Syngeneic Lymphocytes in HIV-Infected Identical Twins
Drug Data
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
Summary
Study start date: March 1, 1993
Actual date on which the first participant was enrolled.This phase I/II pilot project will evaluate the survival, tolerance, safety, and efficacy of infusions of activated, gene marked, syngeneic T lymphocytes obtained from HIV seronegative identical twins on the functional immune status of HIV infected twin recipients. T cells from each seronegative twin will be obtained by periodic apheresis, induced to polyclonal proliferation with anti-CD3 and rIL-2 stimulation, transduced with distinctive neoR retroviral vectors, and expanded 10-1,000 fold in numbers during approximately 2 weeks of culture. These marked T cells will then be infused into the seropositive twins and the survival of the uniquely marked T cell populations will be monitored by vector-specific PCR, while the recipients' functional immune status is monitored by standard in vitro and in vivo testing protocols. A total of 3 cycles of treatment may be given at intervals of 6 weeks between infusions.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
An identical twin pair, one of whom is seropositive for HIV, the other twin seronegative, by standard ELISA and Western blot testing. Patients with Kaposi's sarcoma are eligible for this study, but must not have received any systemic therapy for KS within 4 weeks prior to entry. The diagnosis of KS must have been confirmed by biopsy. Patients must be free from serious psychological or emotional illness and able to provide written informed consent. Anticipated survival greater than 3 months. 18 years of age or older. Treatment with FDA-approved and/or expanded access antiretroviral agent(s) for patients with baseline CD4 counts below 500 cells/mm3. Patients with baseline CD4 counts above 500 cells/mm3 are eligible to receive cell therapy on this protocol, but must be treated with antiretroviral therapy if evidence of significant and persistent viral activation occurs in association with a cell infusion (a 50 percent or greater increase above baseline in any virologic parameter for at least 2 consecutive weeks). No patients with lymphoma. Willing to comply with current NIH Clinical Center guidelines concerning appropriate notification of all current sexual partners of an individual regarding his or her HIV positive sero-status and the risk of transmission of HIV infection. No recent history of substance abuse unless evidence is provided of an ongoing therapeutic intervention (i.e., medical therapy or counseling) to control such abuse. No pregnancy.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, United StatesOpen National Institute of Allergy and Infectious Diseases (NIAID) in Google Maps