Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Fosamprenavir, fosamprenavir (GW433908)
fosamprenavir+ ritonavir+ methadone · 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...
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Fosamprenavir is used to treat HIV infection, including HIV-1, in adults and adolescents. It is studied as part of combination antiretroviral regimens, often with ritonavir, and sometimes alongside methadone in patients receiving opioid substitution therapy. The drug is a small molecule protease inhibitor developed by GSK plc.
Fosamprenavir targets HIV protease, an enzyme the virus needs to process its polyprotein into functional components. By inhibiting this enzyme, fosamprenavir blocks viral maturation and replication. Ritonavir is added to boost fosamprenavir levels, while methadone is an opioid used for addiction treatment and is not an antiviral.
Fosamprenavir is developed by GSK plc, which trades under the ticker GSK. The company conducted the clinical development program for fosamprenavir, including studies of fosamprenavir with ritonavir and in combination with other antiretroviral agents.
Fosamprenavir has been studied in Phase 3 clinical trials. The development program includes completed Phase 3 studies in HIV-infected adults and adolescents. It is an investigational small molecule protease inhibitor for HIV infection, and the trials listed are all completed.
Fosamprenavir has been evaluated in completed Phase 3 trials including NCT00450580, which compared once-daily versus twice-daily protease inhibitor regimens in treatment-naive adults, and NCT00296504, which assessed fosamprenavir-containing regimens in HIV-1 infected subjects. Other completed studies include NCT00094523 and NCT00043888.