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NCT00001647 · ClinicalTrials.gov registry record · Phase 1
White Blood Cell Infusions to Treat HIV Infection
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00001647 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 30 participants.
The verdict
NCT00001647, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will evaluate the safety and immune system effects of infusing HIV-infected patients with multiple doses of lymphocytes (white blood cells) from their non-infected identical twin. It will determine whether the donated lymphocytes can improve immune function and reduce viral load in the infected twin. Identical twin pairs-one who is infected with HIV-1 and one who is negative for the virus-may be eligible for this study. Candidates will be screened with blood tests, a medical history and physical examination. Both twin participants will receive a tetanus booster shot, if needed. The non-infected twin will undergo apheresis to collect white blood cells. For this procedure, whole blood is collected, similar to the procedure for donating a unit of blood from a needle in the arm. The blood flows through a cell separator machine where the white cells are removed, and the rest of the blood (red cells, plasma and platelets) is returned to the donor through a catheter in the opposite arm. The collected lymphocytes will be given intravenously (through a vein) to the infected twin over a 60-minute period. This procedure-apheresis and infusions-will be repeated 4 days a week to complete one cycle. The cycles will be repeated about every 8 weeks for 6 cycles (about 1 year). The infected twin will have blood samples drawn on the first day of each cycle, 2 weeks after the beginning of each cycle, and 4 weeks after each cycle to evaluate immune status, viral load and other safety parameters. The frequency of these blood tests may change as the study progresses. The infected twin will also undergo apheresis immediately before each cycle of infusions and one month later to test the white cells for certain immune features. The number of apheresis procedures may be reduced as the study proceeds.
Interventions
- PROCEDURE White blood cell infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 1997-08 |
| Est. Completion | 2002-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001647
The ClinicalTrials.gov registry entry for NCT00001647 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 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 White blood cell infusion is the first listed.
NCT00001647 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001647 about?
NCT00001647 is a clinical study titled "White Blood Cell Infusions to Treat HIV Infection". This study will evaluate the safety and immune system effects of infusing HIV-infected patients with multiple doses of lymphocytes (white blood cells) from their non-infected identical twin. It will determine whether the donated lymphocytes can improve immune function and reduce viral load in the in...
What is the current status of trial NCT00001647?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 1997-08. Estimated completion is 2002-08.
What interventions are being tested in trial NCT00001647?
The interventions under investigation include: White blood cell infusion (PROCEDURE).
Who is sponsoring clinical trial NCT00001647?
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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