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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

NCT ID: NCT01177059

Last Updated: 2018-12-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-06

Study Completion Date

2017-11-30

Brief Summary

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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.

Detailed Description

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During an earlier phase 2 base trial (study # NCT00074997), HIV-1 infected patients received a gene therapy product (anti-HIV-1 Ribozyme \[OZ1\]). Gene therapy is an investigational treatment where genes are inserted into an individual's cells and tissues to treat a disease. The gene therapy OZ1 is thought to have anti-HIV-1 actions. This is an Observational Study to provide long term follow-up of those HIV-1 infected patients who received the gene therapy product (anti-HIV-1 Ribozyme \[OZ1\]) as part of the earlier study. 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. Observational study - no investigational drug administered.

Conditions

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HIV-1

Keywords

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Gene Therapy Anti-HIV-1 Ribozyme OZ1 HIV-1 Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Anti-HIV-1 Ribozyme (OZ1) transduced cells

OZ1 transduced cells Long term follow up of previously infused OZ1 transduced cells

Group Type OTHER

OZ1 transduced cells

Intervention Type GENETIC

Long term follow up of previously infused OZ1 transduced cells

Interventions

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OZ1 transduced cells

Long term follow up of previously infused OZ1 transduced cells

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* All patients who were enrolled (between 18 and 45 years of age) in the base study "OTH/OZ1-INT-1" (NCT00074997) will be invited to participate in this long term follow-up study
* Patients must have received the Final Cell Product infusion in base study "OTH/OZ1-INT-1"
* Have signed Informed Consent Form

Exclusion Criteria

* All patients who were enrolled in the OTH/OZ1-INT-1 study and received the final cell product will be invited to participate in this long term follow-up study. After unblinding of the OTH/OZ1-INT-1 study, any patients in the placebo arm will be withdrawn from this protocol
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen-Cilag Pty Ltd Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Pty Ltd

Locations

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Los Angeles, California, United States

Site Status

San Francisco, California, United States

Site Status

New York, New York, United States

Site Status

Darlinghurst, , Australia

Site Status

Surry Hills, , Australia

Site Status

Sydney, , Australia

Site Status

Countries

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United States Australia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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OZ1-HV1-202

Identifier Type: OTHER

Identifier Source: secondary_id

CR016027

Identifier Type: -

Identifier Source: org_study_id