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NCT01177059 · ClinicalTrials.gov registry record · Phase 2
Long Term Follow-Up Study of Human Immunodeficiency Virus Type 1 (HIV-1) Positive Patients Who Have Received OZ1 Gene Therapy as Part of a Clinical Trial
A Phase 2 study of HIV-1, sponsored by Janssen-Cilag Pty.
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 6
- Study locations
NCT01177059: Completed Phase 2 study of HIV-1, sponsored by Janssen-Cilag Pty.
NCT01177059 is a Phase 2 study of HIV-1 that has completed, run by Janssen-Cilag Pty. The registered enrollment target is 68 participants, below the 129-participant average among 9 other HIV-1 trials with a reported enrollment target (47% lower). The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01177059, a Phase 2 study of HIV-1, has completed, sponsored by Janssen-Cilag Pty.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this Observational Study is long term follow-up of the Human Immunodeficiency Virus -1 (HIV-1) infected patients who have received a gene therapy product (anti-HIV-1 Ribozyme \[OZ1\]) as part of an earlier phase 2 trial. Patients are seen twice yearly until 5 years from initial infusion of study drug has elapsed and then yearly until withdrawal or study completion. The study will monitor for and record any ill effects from the gene therapy product to provide long term safety information.
Primary Outcome
Percentage of participants with clonal expansion of cells with a predominant OZ1 insertion site was reported. A predominant integration site was defined as an integration site which has a density of at least 50 percent (%) of the total signal detected by polymerase chain reaction (PCR), when the percentage of cells marked by vector was greater than (\>)1% of the test cell population.
Conditions Studied
Interventions
- GENETIC OZ1 transduced cells
Study Locations (6)
Other
- - Darlinghurst
- - Surry Hills
- - Sydney
California
- - Los Angeles
- - San Francisco
New York
- - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2004-12-06 |
| Est. Completion | 2017-11-30 |
| Phase | Phase 2 |
What the finished NCT01177059 record still lists
NCT01177059 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 129-participant average among 9 other HIV-1 trials with a reported enrollment target (47% lower).
The record links to 1 condition, with HIV-1 appearing as the primary indexed condition, and to 1 intervention - of which OZ1 transduced cells is the first listed.
NCT01177059 lists 6 locations in 3 states (Other, California, New York).
Frequently Asked Questions
What is clinical trial NCT01177059 about?
NCT01177059 is a clinical study titled "Long Term Follow-Up Study of Human Immunodeficiency Virus Type 1 (HIV-1) Positive Patients Who Have Received OZ1 Gene Therapy as Part of a Clinical Trial". The purpose of this Observational Study is long term follow-up of the Human Immunodeficiency Virus -1 (HIV-1) infected patients who have received a gene therapy product (anti-HIV-1 Ribozyme \[OZ1\]) as part of an earlier phase 2 trial. Patients are seen twice yearly until 5 years from initial infusi...
What is the current status of trial NCT01177059?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2004-12-06. Estimated completion is 2017-11-30.
What conditions does trial NCT01177059 study?
This clinical trial studies the following conditions: HIV-1.
What interventions are being tested in trial NCT01177059?
The interventions under investigation include: OZ1 transduced cells (GENETIC).
Who is sponsoring clinical trial NCT01177059?
This trial is sponsored by Janssen-Cilag Pty, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01177059 being conducted?
This trial has 6 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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