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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: July 11, 2017
Last verified: July 2017
August 5, 2010
July 11, 2017
December 6, 2004
November 30, 2017   (Final data collection date for primary outcome measure)
Adverse events, reportable events such as cancers and deaths [ Time Frame: Start from the signing of the informed consent until withdrawal or study completion (minimum of 10 years post-infusion) ]
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. ]
Complete list of historical versions of study NCT01177059 on ClinicalTrials.gov Archive Site
  • Clonal expansion of cells with a predominant OZ1 insertion site [ Time Frame: Visits will be at six monthly intervals from year 2.5 to year 5.0 post-infusion, then annual visits year 5+ until withdrawal or end-study visit (minimum of 10 years post-infusion) ]
  • Assess quantitative marking of the gene transfer product in peripheral blood mononuclear cells (PBMC) over time [ Time Frame: Visits will be at six monthly intervals from year 2.5 to year 5.0 post-infusion, then annual visits year 5+ until withdrawal or end-study visit (minimum of 10 years post-infusion) ]
  • 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 over time [ Time Frame: For a minimum of 15 years ]
Not Provided
Not Provided
 
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 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
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.
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Other
HIV-1
Genetic: OZ1 transduced cells
Long term follow up of previously infused OZ1 transduced cells
Anti-HIV-1 Ribozyme (OZ1) transduced cells
OZ1 transduced cells Long term follow up of previously infused OZ1 transduced cells
Intervention: Genetic: OZ1 transduced cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
37
November 30, 2017
November 30, 2017   (Final data collection date for primary outcome measure)

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:

  • Any patient from the base study "OTH/OZ1-INT-1" that was assigned to the placebo arm
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Australia,   United States
 
 
NCT01177059
CR016027
OZ1-HV1-202 ( Other Identifier: Janssen-Cilag Pty Ltd, Australia )
No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Janssen-Cilag Pty Ltd
Janssen-Cilag Pty Ltd
Not Provided
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
Janssen-Cilag Pty Ltd
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP