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NCT00001353 · ClinicalTrials.gov registry record
Safety and Survival of Genetically Modified White Blood Cells in HIV-Infected Persons - A Study in Identical Twin Pairs
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 24
- Enrollment target
NCT00001353 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 24 participants.
The verdict
NCT00001353 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 24 participants
- Enrollment target
Study Summary
This study will evaluate the safety of giving lymphocytes (white blood cells) containing a new gene to HIV-infected individuals and will determine how long the cells survive in the bloodstream. Although the genetically altered cells will not directly benefit participants, knowledge about the safety, side effects and survival of these gene-marked cells in HIV-infected patients may lead to new treatment strategies. Identical twin pairs 18 years of age and older-one infected with HIV, the other non-infected-may be eligible for this study. Candidates will be screened with a medical history, physical examination and blood tests. All participants will have a tetanus booster shot. Non-infected twins will undergo a procedure called apheresis to collect white blood cells. For this procedure, whole blood is collected through a needle in an arm vein, similar to donating blood. The blood is separated it into its components by centrifugation (spinning), the white cells are removed, and the rest of the blood is returned to the body, either through the same needle or through another needle in the other arm. The harvested white cells will be grown in culture for approximately 10 days to 2 weeks to increase their numbers up to 1000-fold. A gene called NeoR, which is derived from bacteria, will be inserted into the cells, and these gene-marked cells will be infused into the HIV-infected twin. HIV-infected twins will be admitted to the NIH Clinical Center for the first cell infusion. The gene-marked cells will be infused over a 60-minute period through a plastic tube (catheter) placed in an arm vein, or, if a suitable arm vein cannot be found, through a special catheter placed into a large vein in the neck or chest. Vital signs (temperature, pulse, blood pressure and breathing rate), blood oxygen concentration, and urine output will be monitored regularly for 24 hours. Blood samples will be collected before and after the infusion to monitor for gene-marked cells. Patients will be d
Interventions
- DRUG Genetically Marked Syngeneic T Lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 1993-03 |
| Est. Completion | 2002-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001353
The ClinicalTrials.gov registry entry for NCT00001353 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Genetically Marked Syngeneic T Lymphocytes is the first listed.
NCT00001353 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001353 about?
NCT00001353 is a clinical study titled "Safety and Survival of Genetically Modified White Blood Cells in HIV-Infected Persons - A Study in Identical Twin Pairs". This study will evaluate the safety of giving lymphocytes (white blood cells) containing a new gene to HIV-infected individuals and will determine how long the cells survive in the bloodstream. Although the genetically altered cells will not directly benefit participants, knowledge about the safety,...
What is the current status of trial NCT00001353?
This trial is currently completed. The enrollment target is 24 participants. The study started on 1993-03. Estimated completion is 2002-03.
What interventions are being tested in trial NCT00001353?
The interventions under investigation include: Genetically Marked Syngeneic T Lymphocytes (DRUG).
Who is sponsoring clinical trial NCT00001353?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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