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NCT04799483 · ClinicalTrials.gov registry record
Safety and Survival of Genetically Modified White Blood Cells in HIV-infected Twins The Gemini Study
A clinical trial of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- 32
- Enrollment target
- 1
- Study location
NCT04799483: Active study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04799483 is a study of HIV that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 32 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04799483, a study of HIV, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- 32 participants
- Enrollment target
- 1
- Study location
Study 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 transfer/gene 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.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2001-01-05 |
| Est. Completion | 2030-01-30 |
What the registry record for NCT04799483 still lists
NCT04799483 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (93% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 0 interventions.
NCT04799483 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04799483 about?
NCT04799483 is a clinical study titled "Safety and Survival of Genetically Modified White Blood Cells in HIV-infected Twins The Gemini Study". 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 transfer/gene therapy studies on a single, mor...
What is the current status of trial NCT04799483?
This trial is currently active not recruiting. The enrollment target is 32 participants. The study started on 2001-01-05. Estimated completion is 2030-01-30.
What conditions does trial NCT04799483 study?
This clinical trial studies the following conditions: HIV.
Who is sponsoring clinical trial NCT04799483?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04799483 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04799483's enrollment target sits among peer trials
32 260th of 303 higher than 42 of 303 other HIV trials
participants (enrollment target), bucketed by value
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