Search / Trial NCT00001535

Twins Study of Gene Therapy for HIV Infection

Launched by NATIONAL HUMAN GENOME RESEARCH INSTITUTE (NHGRI) · Nov 3, 1999

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Intracellular Immunization Immune Based Therapy Ex Vivo Cell Processing Identical Twins Hiv/Aids Kaposi's Sarcoma

Description

This phase I/II pilot study will evaluate the safety, relative survival, and potential efficacy of infusions of activated, genetically engineered, syngeneic CD4+ T lymphocytes obtained from HIV-1 seronegative identical twins. T cells from each seronegative twin will be obtained by apheresis, enriched for CD4+ cells, induced to polyclonal proliferation with anti-CD3 and rIL-2 stimulation, divided into aliquots which will then be individually transduced with a control retroviral vector and up to two additional retroviral vectors containing potentially therapeutic genes (antisense TAR and/or t...

Gender

All

Eligibility criteria

  • INCLUSION CRITERIA:
  • An identical twin pair, one of whom is seropositive for HIV-1, the other twin seronegative, by standard ELISA and Western blot testing.
  • 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 diagnosis of KS must have been confirmed by biopsy.
  • 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/mm(3). Patients with baseline CD4 counts above 500 cells/mm(3) 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. "Significant and persistent viral activation" is defined as a 50 percent or greater increase above baseline in any virologic parameter for at least 2 consecutive weeks.
  • Recipient's CD4 count greater than 50 cells/mm(3).
  • Recipient and Donor willing to have samples stored and undergo HLA testing.
  • EXCLUSION CRITERIA (Donor and Recipient):
  • Lymphomas.
  • Unwillingness 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.
  • Recent history of substance abuse unless evidence is provided of an ongoing therapeutic intervention (i.e. medical therapy or counseling) to control such abuse.
  • Pregnant 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.
  • EXCLUSION CRITERIA (Donor):
  • Untreated or inadequately treated medical condition (e.g., cardiopulmonary disease, acute infection) which, in the judgement of the Principal Investigator, precludes apheresis.
  • Serologic positivity for Epstein Barr virus, Cytomegalovirus, Hepatitis B or Hepatitis C, if and only if the recipient twin tests seronegative for the corresponding virus.

Attachments

readout_NCT00001535_2023-12-10.pdf

4.5 MB

NCT00001535_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
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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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