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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01177059|
Recruitment Status : Completed
First Posted : August 6, 2010
Results First Posted : December 12, 2018
Last Update Posted : December 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV-1||Genetic: OZ1 transduced cells||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Actual Study Start Date :||December 6, 2004|
|Actual Primary Completion Date :||November 30, 2017|
|Actual Study Completion Date :||November 30, 2017|
Anti-HIV-1 Ribozyme (OZ1) transduced cells
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
- Percentage of Participants With Clonal Expansion of Cells With a Predominant OZ1 Insertion Site [ Time Frame: Approximately up to 15 years ]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.
- Percentage of Participants With Insertional Oncogenesis [ Time Frame: Approximately up to 15 years ]Percentage of participants with insertional oncogenesis by clonal expansion of cells modified with OZ1/LNL6 were reported.
- Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time [ Time Frame: Up to end of study (Approximately up to 15 years) ]OZ1 and LNL6 marking analysis were performed by quantitative deoxyribonucleic acid-polymerase chain reaction (DNA-PCR). Number of participants in each of 3 categories for gene detection: Not Detected, Detected (1, 2 and 3 of the 3 triplicates of the sample were detected respectively [1/3 Detected, 2/3 Detected, 3/3 Detected]) and Detected (Quantifiable) were reported for marking of gene transfer product in PBMC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177059
|United States, California|
|Los Angeles, California, United States|
|San Francisco, California, United States|
|United States, New York|
|New York, New York, United States|
|Surry Hills, Australia|
|Study Director:||Janssen-Cilag Pty Ltd Clinical Trial||Janssen-Cilag Pty Ltd|