Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VGX-410 · 2 trials · 2 indications
Mean log change in HIV RNA viral load (significant reduction is considered \>0.5 log 10) from baseline (Day 1) to Day 56 following 150mg twice daily for 14 days, dose escalation to 300mg twice daily for 14 days and then 28 days off treatment.
Mean log change in HCV RNA viral load (significant reduction is considered \>0.5 log 10) from baseline (Day 1) following once or twice daily dosing for 28 days at the 28 day timepoint
| Arm | Type | Description |
|---|---|---|
| VGX-410 (Mifepristone) | ACTIVE_COMPARATOR | 150mg twice daily of VGX-410 for 14 days and, if well tolerated, a dose escalation to 300mg twice daily of VGX-410 for 14 days |
| Placebo for VGX-410 (Mifepristone) | PLACEBO_COMPARATOR | 150mg twice daily of placebo for VGX-410 for 14 days and, if well tolerated, a dose escalation to 300mg twice daily of placebo for VGX-410 for 14 days |
| Placebo | PLACEBO_COMPARATOR | - |
| 150 mg daily | ACTIVE_COMPARATOR | - |
| 300mg daily | ACTIVE_COMPARATOR | - |
| 300mg twice daily | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| VGX-410 (Mifepristone) | DRUG | - |
| Placebo for VGX-410 (Mifepristone) | DRUG | - |
| Placebo | DRUG | Placebo for VGX-410 tablets taken daily or twice daily for 28 days |
Inclusion Criteria: * HIV-1 infection * CD4 cell count \> 200 * Plasma HIV-1 RNA \> 2000 copies/mL and have not received antiretroviral therapy within the 16 weeks prior to entry * Absolute neutrophil count \> 750/mm3 * Hemoglobin \> 10 g/dL * Platelet count \> 100,000 mm3 * Creatinine \< 2 X upper...
VGX-410 is an investigational small molecule being developed for the treatment of HIV infections and hepatitis C virus infection. It is currently in Phase 2 clinical development and has been studied in completed trials for both conditions.
VGX-410 is being developed by Inovio Pharmaceuticals, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol INO. The company is conducting clinical trials to evaluate the drug's safety and antiviral activity.
VGX-410 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy for treating HIV infections and hepatitis C virus infection.
VGX-410 has been studied in two completed Phase 2 clinical trials. One trial, NCT00255177, evaluated the antiviral activity and safety of three different doses in hepatitis C infected patients. Another trial, NCT00352911, assessed the antiviral activity and safety of two doses in HIV-1 infected subjects.
VGX-410 is also known as mifepristone. Clinical trials for VGX-410 have been conducted under the name mifepristone, including studies in hepatitis C and HIV infected patients. The drug is being investigated for its antiviral properties in these infectious disease indications.