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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier:
NCT01177059
First received: August 5, 2010
Last updated: December 29, 2016
Last verified: December 2016
  Purpose
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 for the rest of their lives. The study will monitor for and record any ill effects from the gene therapy product to provide long term safety information.

Condition Intervention Phase
HIV-1
Genetic: OZ1 transduced cells
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Long Term Follow-up Protocol to Evaluate the Safety and Survival of Autologous CD34+ Hematopoietic Progenitor Cells Transduced With an Anti-HIV-1 Ribozyme (OZ1) in Patients With HIV-1 Infection

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Pty Ltd:

Primary Outcome Measures:
  • Adverse events, reportable events such as cancers and deaths [ Time Frame: Lifetime of the patient. Each patient will have visits every 6 months until 5 years post infusion, then annual visits for safety assessments, until their death. ]

Secondary Outcome Measures:
  • Clonal expansion of cells with a predominant OZ1 insertion site [ Time Frame: Lifelong follow-up ]
  • Assess quantitative marking of the gene transfer product in peripheral blood mononuclear cells (PBMC) over time [ Time Frame: For a minimum of 15 years ]

Enrollment: 37
Study Start Date: December 2004
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
001
OZ1 transduced cells Long term follow up of previously infused OZ1 transduced cells
Genetic: OZ1 transduced cells
Long term follow up of previously infused OZ1 transduced cells

Detailed Description:
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 for the rest of their lives. 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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have received the Final Cell Product infusion in base study
  • Have signed Informed Consent Form

Exclusion Criteria:

  • Any patient from the base study that was assigned to the placebo arm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177059

Locations
United States, California
Los Angeles, California, United States
San Francisco, California, United States
United States, New York
New York, New York, United States
Australia
Darlinghurst, Australia
Surry Hills, Australia
Sydney, Australia
Sponsors and Collaborators
Janssen-Cilag Pty Ltd
Investigators
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
  More Information

Responsible Party: Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier: NCT01177059     History of Changes
Other Study ID Numbers: CR016027
OZ1-HV1-202 ( Other Identifier: Janssen-Cilag Pty Ltd, Australia )
Study First Received: August 5, 2010
Last Updated: December 29, 2016

Keywords provided by Janssen-Cilag Pty Ltd:
Gene Therapy
Anti-HIV-1 Ribozyme
OZ1
HIV-1 Infections

ClinicalTrials.gov processed this record on April 27, 2017