Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04799483
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2021-03-15
Brief Title:
Safety and Survival of Genetically Modified White Blood Cells in HIV-infected Twins The Gemini Study
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Gemini Study Study of the Long-Term Safety and Persistence of Cells Following Cell Transfers or Gene Therapy in Identical Twins Discordant for HIV Infection
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
This study will consolidate under one umbrella protocol all NIH studies of the safety and survival of gene-modified lymphocytes in HIV-infected twins The major purposes of the current study are to
place subjects from the various identical twin cell transfergene therapy studies on a single more uniform schedule of visits
examine the long-term safety of apheresis procedures in non-HIV-infected lymphocyte donor twins
examine the long-term safety of lymphocytes in HIV-infected lymphocyte recipient twins
Identical twins enrolled in NIH protocols 93-I-0110 94-I-0206 96-HG-0051 and 97-I-0165 involving the transfer of lymphocytes for the treatment of HIV infection are eligible to continue their research participation under the current protocol 02-I-0080
Participants will not undergo any additional research procedures in this study They will continue to take their antiretroviral therapy and will be followed at least once a year or more often if medically indicated with a medical history physical examination and blood tests for routine studies and to determine the number of lymphocytes in the blood Recipient twins will also have blood levels of gene-modified lymphocytes checked
Recipient twins will have some blood stored for RCR replication competent retrovirus testing should it become necessary A special virus was used to insert genes into the donated lymphocytes and although the virus was rendered incapable of growing in the body a theoretical risk exists that the virus could mix with other viruses and possibly begin growing or reproducing If a participant subsequently develops medical problems the stored blood samples can be checked for RCR to see if it may be a cause of the problem
place subjects from the various identical twin cell transfergene therapy studies on a single more uniform schedule of visits
examine the long-term safety of apheresis procedures in non-HIV-infected lymphocyte donor twins
examine the long-term safety of lymphocytes in HIV-infected lymphocyte recipient twins
Identical twins enrolled in NIH protocols 93-I-0110 94-I-0206 96-HG-0051 and 97-I-0165 involving the transfer of lymphocytes for the treatment of HIV infection are eligible to continue their research participation under the current protocol 02-I-0080
Participants will not undergo any additional research procedures in this study They will continue to take their antiretroviral therapy and will be followed at least once a year or more often if medically indicated with a medical history physical examination and blood tests for routine studies and to determine the number of lymphocytes in the blood Recipient twins will also have blood levels of gene-modified lymphocytes checked
Recipient twins will have some blood stored for RCR replication competent retrovirus testing should it become necessary A special virus was used to insert genes into the donated lymphocytes and although the virus was rendered incapable of growing in the body a theoretical risk exists that the virus could mix with other viruses and possibly begin growing or reproducing If a participant subsequently develops medical problems the stored blood samples can be checked for RCR to see if it may be a cause of the problem
Detailed Description:
Intramural NIAID sponsored several phase I-II studies of cell transfers during the 1990s including gene-modified cells in identical twins discordant for HIV infection These studies were both novel in the field of alternative treatment strategies for HIV infection and served as early studies in the developing field of clinical gene therapy The current protocol represents an umbrella protocol in which these early trials have been consolidated for purposes of long-term safety monitoring and long-term follow-up of gene-modified cell persistence Cell recipients as well as donors enrolled in Intramural NIAID twin gene marking gene therapy and cell transfer studies have been eligible for study participation Participants are monitored for safety per a uniform standardized schedule No gene therapy cell transfers or other investigational therapeutic interventions occur under the auspices of this protocol
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 |
|---|---|---|---|
| 02-I-0080 | None | None | None |