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NCT00001535 · ClinicalTrials.gov registry record · Phase 1
Twins Study of Gene Therapy for HIV Infection
A Phase 1 study of HIV Infection and Acquired Immunodeficiency Syndrome, sponsored by National Human Genome Research Institute (NHGRI).
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT00001535 is a Phase 1 study of HIV Infection and Acquired Immunodeficiency Syndrome that has completed, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 48 participants, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00001535, a Phase 1 study of HIV Infection and Acquired Immunodeficiency Syndrome, has completed, sponsored by National Human Genome Research Institute (NHGRI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test the safety and effectiveness of genetically altered T lymphocytes (white blood cells of the immune system) in reducing viral load in patients infected with the human immunodeficiency virus (HIV). The lymphocytes will have two genes inserted into them; a laboratory-manufactured anti-HIV gene designed to inhibit HIV reproduction (either the RevTD or Rev-TD-antiTAR gene), and a "marker" gene that will show whether or not the inserted genes have gotten into the cells. Identical twin pairs 18 years of age and older- one of whom is HIV-positive (infected with the human immunodeficiency virus) and the other HIV-negative (not infected) may be eligible for this study. All participants will have a complete medical history and physical examination, blood tests and a tetanus booster shot, if indicated. The non HIV-infected twin will then undergo lymphapheresis to collect lymphocytes. In this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The lymphocytes are then removed, and the red cells and plasma are returned to the donor, either through the same needle or through a second needle placed in the other arm. The donor cells are grown in the laboratory for a few days, and then the new genes are inserted into them. The genetically altered cells are grown in the laboratory for several days until their numbers increase approximately a thousand-fold. They are then infused intravenously (through a vein) into the infected twin. These procedures-lymphapheresis, gene modification and infusion-will be repeated at approximately 2-month intervals up to four times. Each lymphocyte infusion takes about 60 minutes. The patient's vital signs (temperature, pulse, blood pressure and breathing) are monitored frequently during the infusion and hourly for 4 hours after the infusion. Blood samples are taken the day of the infusion, 3 days later, and then weekly to monito
Conditions Studied
Interventions
- DRUG Syngeneic Lymphocytes (CD4+) Cultured with OKT3 (Ortho) and Interleukin-2 (Chiro
Study Locations (1)
Maryland
- National Human Genome Research Institute (NHGRI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 1996-03 |
| Est. Completion | 2002-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001535
The ClinicalTrials.gov registry entry for NCT00001535 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (80% lower). The listed sponsor is National Human Genome Research Institute (NHGRI), which has 185 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with HIV Infection appearing as the primary indexed condition, and to 1 intervention - of which Syngeneic Lymphocytes (CD4+) Cultured with OKT3 (Ortho) and Interleukin-2 (Chiro is the first listed.
NCT00001535 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001535 about?
NCT00001535 is a clinical study titled "Twins Study of Gene Therapy for HIV Infection". This study will test the safety and effectiveness of genetically altered T lymphocytes (white blood cells of the immune system) in reducing viral load in patients infected with the human immunodeficiency virus (HIV). The lymphocytes will have two genes inserted into them; a laboratory-manufactured a...
What is the current status of trial NCT00001535?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 1996-03. Estimated completion is 2002-03.
What conditions does trial NCT00001535 study?
This clinical trial studies the following conditions: HIV Infection, Acquired Immunodeficiency Syndrome, Kaposi's Sarcoma.
What interventions are being tested in trial NCT00001535?
The interventions under investigation include: Syngeneic Lymphocytes (CD4+) Cultured with OKT3 (Ortho) and Interleukin-2 (Chiro (DRUG).
Who is sponsoring clinical trial NCT00001535?
This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001535 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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