Status:
ACTIVE_NOT_RECRUITING
Safety and Survival of Genetically Modified White Blood Cells in HIV-infected Twins The Gemini Study
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV
Eligibility:
All Genders
21+ years
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: ...
Detailed Description
Intramural NIAID sponsored several phase I-II studies of cell transfers during the 1990's, including gene-modified cells, in identical twins discordant for HIV infection. These studies were both novel...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Activet participation, in an NIAID/CCMD/NHGRI protocol involving the transfer of unmodified lymphocytes, gene-marked lymphocytes or cells containing potentially therapeutic genes in the treatment of HIV-1 infection (cell donors and recipients were eligible).
- Ongoing follow-up with a primary medical care provider who manages the subject's HIV-related and/or other medical conditions.
- Agree to comply with study requirements and clinical policies.
- Able to provide informed consent.
- EXCLUSION CRITERIA:
- A history of gross noncompliance with prior NIAID/CCMD protocol requirements that, in the opinion of the Principal Investigator, is likely to seriously compromise the safety or value of an individual's participation in the present protocol.
- Refusal to follow Clinical Center policy on partner notification (if HIV-positive).
- Refusal to permit research blood specimens to be stored (frozen) for potential future studies, including RCR testing will be excluded (participants who have received gene-modified cells may refuse to have specimens stored for research purposes other than RCR).
- Any medical condition that, in the opinion of the Principal Investigator, would make the subject inappropriate for protocol participation (such as anemia or inadequate venous access).
- Refusal to allow the NIH research team to exchange pertinent medical information with the subjects primary medical care provider.
Exclusion
Key Trial Info
Start Date :
January 5 2001
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 30 2030
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04799483
Start Date
January 5 2001
End Date
January 30 2030
Last Update
March 22 2024
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892