Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01177059 | 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 | PHASE2 | COMPLETED | 68 | — | — | Dec 6, 2004 | Nov 30, 2017 | Dec 12, 2018 | 6 | United States, Australia |
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 by clonal expansion of cells modified with OZ1/LNL6 were reported.
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.
| Arm | Type | Description |
|---|---|---|
| Anti-HIV-1 Ribozyme (OZ1) transduced cells | OTHER | OZ1 transduced cells Long term follow up of previously infused OZ1 transduced cells |
| Name | Type | Description |
|---|---|---|
| OZ1 transduced cells | GENETIC | Long term follow up of previously infused OZ1 transduced cells |
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 s...