Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Enfuvirtide · 6 trials · 1 indication
The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.
| Arm | Type | Description |
|---|---|---|
| Enfuvirtide + OB (Not Randomized) | EXPERIMENTAL | Participants will receive enfuvirtide 90 milligram (mg) twice daily (b.i.d.) and OB as per investigator's discretion for 28 weeks during induction period. After induction period participants not meeting the randomization criteria will receive enfuvirtide 90 mg b.i.d and OB for next 24 weeks (up to Week 52). |
| Enfuvirtide + OB (Randomized) | EXPERIMENTAL | Participants will receive enfuvirtide 90 mg b.i.d. and OB as per investigator's discretion for 28 weeks during induction period. After induction period participants meeting the randomization criteria will be randomized to receive enfuvirtide 90 mg b.i.d. and OB for next 24 weeks (up to Week 52). |
| OB alone (Randomized) | EXPERIMENTAL | Participants will receive enfuvirtide 90 mg b.i.d. and OB as per investigator's discretion for 28 weeks during induction period. After induction period participants meeting the randomization criteria will be randomized to receive OB alone for next 24 weeks (up to Week 52). |
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Enfuvirtide | DRUG | Participants will receive 90 mg enfuvirtide subcutaneously (SC) b.i.d. |
| Optimized background antiretroviral regimen (OB) | DRUG | Participants will receive OB (nucleoside and or non-nucleoside reverse transcriptase inhibitor and protease inhibitor) as per investigator's discretion. Protocol does not specify any particular OB drugs. |
| enfuvirtide [Fuzeon] | DRUG | 90mg sc bid |
| Optimized background ARV therapy | DRUG | As prescribed |
| Ritonavir | DRUG | - |
| Abacavir sulfate | DRUG | - |
| Amprenavir | DRUG | - |
| Efavirenz | DRUG | - |
Inclusion Criteria: * Participants with HIV-1 infection * Female participants without any risk of pregnancy * Participants previously treated with drugs of 2 or 3 different antiretroviral classes * Participants currently on highly active antiretroviral treatment (HAART) for more than 4 weeks and wi...
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Enfuvirtide is used for the treatment of HIV infections. It is an investigational small molecule being developed by Roche Holding AG (RHHBY) and is currently in Phase 3 clinical development for this indication.
Enfuvirtide is a small molecule that targets HIV infections. It is designed to interfere with the HIV-1 fusion process, preventing the virus from entering host cells. This mechanism is being evaluated in clinical trials for treatment-experienced patients.
Enfuvirtide is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating HIV infections.
Enfuvirtide is in Phase 3 clinical development for HIV infections. It is an investigational drug and has not been approved by regulatory authorities. Six clinical trials have been completed, with no active trials currently ongoing.
Enfuvirtide has been studied in several completed clinical trials, including NCT00002239, NCT00022763, NCT00615134, and NCT02733419. These trials evaluated the drug in HIV-infected adults and children, often in combination with other antiretroviral therapies.
Enfuvirtide is also known as T-20 in clinical research. Several trials, such as NCT00002239 and NCT00022763, refer to the drug as T-20 when studying its effects in HIV-infected patients.