Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fosamprenavir · 5 trials · 5 indications
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at week 48. The percentage of participants with HIV-1 RNA \<400 copies/mL at Week 48 was determined by the Time to Loss Of Virologic Response (TLOVR) algorithm.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG).
blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL.
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.
The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event.
The number of participants with drug-related adverse events coded as Grade 2 (mild), Grade 3 (severe), or Grade 4 (life-threatening).
The number of participants with Grade 3 (severe) or Grade 4 (life-threatening) laboratory abnormalities while on study treatment.
Geometric mean is a type of "average" that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. AUC(0-tau)=area under the concentration curve from time 0 to tau.
Geometric mean is a type of "average" that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. Cmax= concentration maximum.
tmax: time after administration of the drug when maximum concentration is reached
Geometric mean is a type of "average" that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. CL/F=apparent plasma clearance.
Geometric mean is a type of "average" that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. t1/2=elimination half-life. t1/2=elimination half-life.
A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.
A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.
A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Fosamprenavir/ritonavir 1400mg/100mg QD + ABC/3TC FDC 600/300mg QD |
| Arm B | ACTIVE_COMPARATOR | Fosamprenavir/ritonavir 700mg/100mg BID + ABC/3TC FDC 600/300mg QD |
| Treatment Arm A | EXPERIMENTAL | Subjects switched their baseline PI for fosamprenavir (± ritonavir) while maintaining their baseline regimen of two nucleoside or nucleotide reverse transcriptase inhibitors for 48 weeks. |
| Treatment Arm B | EXPERIMENTAL | Subjects continued baseline regimen for first 24 weeks with the option of switching their initial PI for fosamprenavir (± ritonavir) while maintaining their baseline nucleoside or nucleotide reverse transcriptase inhibitor regimen for another 24 weeks |
| 2 to 5 years (FPV/RTV) | EXPERIMENTAL | Two to five years. Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD) |
| 6 to 11 years (FPV/RTV) | EXPERIMENTAL | Six to twelve years. Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD) |
| 12 to 18 years (FPV/RTV) | EXPERIMENTAL | Twelve to Eighteen years. Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD) |
| Name | Type | Description |
|---|---|---|
| fosamprenavir/ritonavir | DRUG | Fosamprenavir (FPV, TELZIR) is currently licensed in Europe for twice daily (BID) dosing in combination with ritonavir (RTV, Norvir) as a boosting agent |
| Fosamprenavir | DRUG | Fosamprenavir |
| COMBIVIR | DRUG | - |
| ritonavir | DRUG | - |
| TRIZIVIR | DRUG | - |
| fosamprenavir (GW433908) | DRUG | - |
Inclusion Criteria: * Subject is ≥18 years of age. * Subject is antiretroviral-naïve (defined as having ≤14 days of prior therapy with any antiretroviral agent). * Subject has plasma HIV-1 RNA ≥1,000 copies/mL at screening. * Subject is willing and able to understand and provide written informed co...
Fosamprenavir is an investigational small molecule being developed for the treatment of HIV infections, including HIV-1 infection in adults and pediatric subjects. It is studied in combination with other antiretroviral agents such as ritonavir, TRIZIVIR, or COMBIVIR. The drug is in Phase 3 clinical development for these indications.
Fosamprenavir is being developed by GSK plc, which trades under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating HIV infections across various patient populations, including pediatric subjects aged 2 to 18 years and adults.
Fosamprenavir is a protease inhibitor that targets the HIV protease enzyme, which is essential for viral replication. By inhibiting this enzyme, the drug aims to prevent the maturation of infectious viral particles. It is being studied in combination with other antiretroviral medications for the treatment of HIV-1 infection.
Fosamprenavir is in Phase 3 clinical development for the treatment of HIV infections. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy in various patient populations, including treatment-naive adults and pediatric subjects.
Fosamprenavir has been studied in several completed clinical trials, including NCT00040664 in pediatric subjects, NCT00043888 in adolescents and adults, NCT00094523 comparing it to other protease inhibitors, and NCT00450580 evaluating once-daily versus twice-daily dosing in treatment-naive adults. These trials enrolled a total of 753 participants.
Fosamprenavir is a distinct protease inhibitor used in combination with other antiretroviral agents. It is not the same as other HIV drugs, but it is often studied alongside medications like ritonavir, TRIZIVIR, and COMBIVIR to enhance its effectiveness. Its unique chemical structure and mechanism differentiate it from other protease inhibitors.