Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Optimized Background ARVs · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Optimized Background ARVs | DRUG | As prescribed |
| enfuvirtide [Fuzeon] | DRUG | 180mg sc once daily for 48 weeks |
Inclusion Criteria: * HIV-1 infected adults or adolescents \>=16 years of age; * HIV-1 RNA \>=5000 copies/mL; * prior experience or documented resistance to each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhi...
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Optimized Background ARVs is an investigational small molecule being studied for the treatment of HIV Infections. It is currently in Phase 2 clinical development. The drug is intended to be used as part of an optimized background regimen for patients with HIV-1 infection.
Optimized Background ARVs is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational drug for the treatment of HIV Infections.
Optimized Background ARVs is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed for this drug.
Optimized Background ARVs has one completed Phase 2 clinical trial, identified as NCT00089492. This study compared the efficacy and safety of once-daily versus twice-daily dosing of Fuzeon (enfuvirtide) in HIV-1 infected patients. The trial enrolled 64 participants across the United States, Canada, and Puerto Rico.
Optimized Background ARVs is not the same as Fuzeon (enfuvirtide). In the clinical trial NCT00089492, Optimized Background ARVs was used as the background antiretroviral regimen, while Fuzeon was the investigational drug being tested. The study compared different dosing schedules of Fuzeon in combination with Optimized Background ARVs.