Ignite Creation Date:
2024-05-05 @ 11:21 AM
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
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 |