White Blood Cell Infusions to Treat HIV Infection

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 3, 1999

Keywords

ClinConnect Summary

This phase I/II study will evaluate the safety, immunologic effects, and potential efficacy of repeated infusions of syngeneic lymphocytes obtained from HIV-1 seronegative identical twins given in the setting of maximum anti-retroviral therapy. Unfractionated lymphocytes from each seronegative twin will be obtained by lymphocytapheresis and directly transferred to the HIV-1 seropositive twin. Four separate lymphocytaphereses and transfers will be performed over one week, and this cycle may be repeated as frequently as every 8 weeks for a total of up to 6 cycles. The recipient twin will be m...

Gender

ALL

Eligibility criteria

• • Identical twin pair, one of whom is seropositive for HIV-1, the other twin HIV seronegative, by standard testing ELISA and Western blot testing.
• • Documented nadir CD4 count of HIV-infected twin less than 100 cells/mm(3) on at least 2 evaluations.
• • Patients with Kaposi's sarcoma limited to the skin and/or mucous membranes are eligible for this study, but must not have received any systemic therapy for KS within 4 weeks prior to entry. The KS activity must be stable such that the patient is unlikely to require systemic therapy (either chemotherapy or radiation) over the next 4 months. The diagnosis of KS must have been confirmed by biopsy.
• • Must be free from serious psychological or emotional illness and able to provide written informed consent.
• • Anticipated survival of greater than 3 months.
• • Must be 18 years of age or older.
• • Maximal (i.e., combination) anti-retroviral therapy, including the use of agents available on an FDA-approved expanded access program, may be used to achieve a virologic response. Patients must be tolerating a stable regimen of anti-retroviral drugs for at least 4 weeks prior to starting study.
• DONOR AND RECIPIENT:
• • No lymphoma or active, life-threatening opportunistic infection. Patients with HIV-related infections requiring chronic suppressive therapy are eligible for study if their condition has been stable for greater than or equal to 4 weeks.
• • Must be 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-1 positive sero-status and the risk of transmission of HIV-1 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 at entry or unwillingness to practice barrier birth control or abstinence during the study.
• • No experimental therapy within 4 weeks of study participation. Antiretroviral agents available on an FDA-sanctioned, expanded access basis are permitted.
• DONOR:
• • Subjects with untreated or inadequately treated medical condition (e.g., cardiopulmonary disease, acute infection) which, in the judgment of the Principal Investigator, precludes apheresis will be excluded.
• • Subjects with serologic positivity for Epstein Barr virus or Cytomegalovirus if the recipient twin tests seronegative for the corresponding virus will be excluded.
• • No serologic findings consistent with active Hepatitis B virus or Hepatitis C virus infection, regardless of the recipient twin's status.
• • Subjects with serologic positivity for HIV-1 or HIV-2. Donors will be tested for HIV prior to each lymphapheresis cycle will be excluded.
• • Both CD4 count and CD4% must not be below the laboratory range for normals.