Search / Trial NCT00001647

White Blood Cell Infusions to Treat HIV Infection

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

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Trial Information

Current as of March 05, 2024

Completed

Keywords

Aids Immunotherapy Adoptive Cell Transfers T Cell Repertoire Identical Twins

Description

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.

Attachments

readout_NCT00001647_2024-03-05.pdf

4.5 MB

NCT00001647_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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