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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 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.

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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.

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

FieldValue
Enrollment Target 68 participants
Start Date 2004-12-06
Est. Completion 2017-11-30
Phase Phase 2

Sponsor

Janssen-Cilag Pty

1 total trials

What the Registry Record Tells You About NCT01177059

The ClinicalTrials.gov registry entry for NCT01177059 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 129-participant average among 9 other HIV-1 trials with a reported enrollment target (47% lower). The listed sponsor is Janssen-Cilag Pty, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 3 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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