Viewing Study NCT00001409



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001409
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 1999-11-03

Brief Title: Genetically Modified Lymphocytes to Treat HIV-Infected Identical Twins - Study Modifications
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: A Phase III Pilot Study of the Safety of the Adoptive Transfer of Syngeneic Gene-Modified Cytotoxic T Lymphocytes in HIV Infected Identical Twins
Status: COMPLETED
Status Verified Date: 2002-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Certain patients enrolled in NIH protocol 94-I-0206 at the Clinical Center may be eligible to participate in one or more of the following new options

Donorrecipient extension phase - Both the recipient HIV-infected twin and donor non-infected twin will participate in this extension of the CD4-zeta gene therapy study It will evaluate the safety and activity of infusing gene-modified CD4 cells as well as the modified CD8 cells
Corticosteroid administration - A corticosteroid such as prednisone hydrocortisone or prednisolone will be added to the interleukin-2 IL-2 regimen for preventing or treating side effects of IL-2 such as fever and other flu-like symptoms
Extended follow-up - A more intensive follow-up will be scheduled for patients with substantial numbers of lymphocytes that harbor the CD4-zeta gene Every 3 months participants will have blood tests and specialized tests of CD4 counts HIV-1 viral load and numbers of circulating cells containing the CD4-zeta gene every 3 months the frequency of follow-up visits may be reduced as time goes by
IL-2 continuation - Participants will continue to receive periodic treatment with IL-2 to see how long the genetically modified cells persist in the bloodstream and to evaluate the long-term response to IL-2
Home treatment with interleukin-2 - Participants may receive future IL-2 treatment cycles at home Home treatment involves less frequent data and safety monitoring and no medical evaluations at the Clinical Center except at the beginning of each cycle
Detailed Description: Open-label comparative sequentially randomized treatment with genetically unmodified or modified ex vivo-expanded T-lymphocytes in patients with HIV infection who possess a seronegative syngeneic twin Genetic modification consists of introduction of a gene for HLA-unrestricted universal receptors specific for the gp120 HIV envelope protein Treatment is divided into Periods I and II

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
94-I-0206 None None None