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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00074997 | An Efficacy and Safety Study of Autologous Cluster of Differentiation 34 (CD34+) Hematopoietic Progenitor Cells Transduced With Placebo or an Anti- Human Immunodeficiency Virus Type 1 (HIV-1) Ribozyme (OZ1) in Participants With HIV-1 Infection | PHASE2 | COMPLETED | 1 | — | — | Dec 1, 2002 | Jan 1, 2008 | Jun 20, 2016 | 1 | Australia |
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | OZ1 Single intravenous infusion of 2-20 x 10 to the power of 7 OZ1 transduced autologous CD34+ cells per kilogram of body weight |
| 002 | PLACEBO_COMPARATOR | Placebo Single intravenous infusion of placebo transduced autologous CD34+ cells per kilogram of body weight |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Single intravenous infusion of placebo. |
| OZ1 | GENETIC | Single intravenous infusion of OZ1. |
| CD34+ cells | GENETIC | Autologous CD34+ cells. |
Inclusion Criteria: * An Human Immunodeficiency Virus 1 (HIV-1) infection for at least 6 months documented by positive HIV serology including confirmation by Western Blot * Receiving either the first or second regimen of antiretroviral therapy (ART) defined as 3 or more antiretroviral drugs in comb...