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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00991224 | Redirected High Affinity Gag-Specific Autologous T Cells for HIV Gene Therapy | PHASE1 | COMPLETED | 2 | — | — | Nov 1, 2009 | Jan 1, 2014 | Oct 10, 2019 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Subjects who are HIV positive, taking medication to control virus, have an undetectable viral load, CD4 count greater than 450 at the time of enrollment, a CD4 nadir \>200 and a recorded historical viral load setpoint, will receive a WT-gag-TCR modified autologous T cells, followed one week later by a 16 week treatment interruption. |
| Arm 2 | EXPERIMENTAL | Subjects who are HIV positive, taking medication to control virus, have an undetectable viral load, CD4 count greater than 450 at the time of enrollment, a CD4 nadir \>200 and a recorded historical viral load setpoint, will receive a α/6-gag-TCR modified autologous T cells, followed one week later by a 16 week treatment interruption. |
| Arm 3 | EXPERIMENTAL | Subjects who are HIV positive, taking medication to control virus, have an undetectable viral load, CD4 count greater than 450 and a CD4 nadir \>200. Subject will undergo an 16 week treatment interruption during which a single infusion of WT-gag-TCR modified autologous T cells at 8 weeks post STI. |
| Arm 4 | EXPERIMENTAL | Subjects who are HIV positive, taking medication to control virus, have an undetectable viral load, CD4 count greater than 450 and a CD4 nadir of \>200. Subject will undergo a 16-week treatment interruption during which a single infusion of α/6-gag-TCR modified autologous T cells at 8 weeks post STI. |
| Name | Type | Description |
|---|---|---|
| WT-gag-TCR modified T cells | BIOLOGICAL | Single dose of WT-gag-TCR modified T cells infused over 3 consecutive days. |
| α/6-gag-TCR modified T cells | BIOLOGICAL | Single dose of WT-gag-TCR modified T cells infused over 3 consecutive days. |
| STI or Drug Holiday | OTHER | Subjects will stop taking antiviral medications for 16 weeks. |
Inclusion Criteria: * Age 18 years or older * Karnofsky Performance of 80 or higher * HLA-A2 Positive * Chronic HIV-1 infection * On stable HAART regimen (with no changes within 4 weeks of study entry) * Willing to undergo a limited treatment interruption of antiretroviral medication * CD4+ T cell ...