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NCT00559416 · ClinicalTrials.gov registry record · Phase 1
Lymphocyte Infusions for the Treatment of HIV-Infected Patients Failing Anti-HIV Therapy
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Terminated
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT00559416 is a Phase 1 study that was terminated before completion, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 14 participants.
The verdict
NCT00559416, a Phase 1 study, was terminated before completion, sponsored by National Institutes of Health Clinical Center (CC).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
Some HIV-infected individuals have a white blood cell marker known as HLA-B\*57 that appears to help control the progress of the disease; however, not all who have the HLA-B\*57 marker are able to control the infection. This study will examine the effects of giving white blood cells with HLA-B\*57 from an individual who controls HIV infection to an individual who cannot control HIV infection, as a form of HIV treatment. All candidates will be screened with a medical history, physical examination, and blood and urine tests. Both donor and recipient volunteers must be HIV-positive individuals 18 years of age or older who have the HLA-B\*57 marker and are receiving care. Donor candidates must have positive HIV antibody tests for at least seven years with a recent CD4 cell count greater than 400 cells/mm?, HIV viral load less than 50 copies/mL, and no previous HIV viral load greater than 1,000 copies/mL. Recipient candidates must have positive HIV antibody tests with a recent CD4 cell count less than 400 cells/mm? and HIV viral load greater than 10,000 copies/mL, and must have failed at least two prior combination antiretroviral regimes and are willing to receive or resume combination antiretroviral therapy. Donor volunteers will be excluded if they have taken certain antiretrovirals drugs, have a medical history of cancer or of other blood-borne illnesses, or have other medical conditions that might interfere with the study. Recipient volunteers will be excluded if they have a medical history of malignant cancer or other medical conditions that might possibly interfere with the study. Donors will undergo apheresis to separate white blood cells from circulating blood before the red blood cells and plasma are returned to the bloodstream. The procedure will take up to five hours, and donors will be required to return for additional tests. Donors may be asked to return for further white blood cell donations, a maximum of six procedures per year. Recipients will undergo
Interventions
- DRUG Cell Transfer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2007-11-08 |
| Est. Completion | 2016-09-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00559416
The ClinicalTrials.gov registry entry for NCT00559416 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cell Transfer is the first listed.
NCT00559416 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00559416 about?
NCT00559416 is a clinical study titled "Lymphocyte Infusions for the Treatment of HIV-Infected Patients Failing Anti-HIV Therapy". Some HIV-infected individuals have a white blood cell marker known as HLA-B\*57 that appears to help control the progress of the disease; however, not all who have the HLA-B\*57 marker are able to control the infection. This study will examine the effects of giving white blood cells with HLA-B\*57 f...
What is the current status of trial NCT00559416?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2007-11-08. Estimated completion is 2016-09-30.
What interventions are being tested in trial NCT00559416?
The interventions under investigation include: Cell Transfer (DRUG).
Who is sponsoring clinical trial NCT00559416?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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