Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Half-boosted Fosamprenavir · 1 trial · 2 indications
Virologic failure was defined as two consecutive plasma HIV-1 RNA measures greater than 400 copies/milliliter (mL) separated by at least 2 to 4 week. The percentage of participants not meeting the virologic failure definition was estimated with stratification by the six randomization strata using Mantel-Haenszel weights and the missing/discontinuation equals failure (MD=F) analysis. Missing/discontinuation values were considered failures.
| Arm | Type | Description |
|---|---|---|
| FPV/r200 | ACTIVE_COMPARATOR | Fosamprenavir/ritonavir (either 700/100mg BID or 1400/200mg QD) |
| FPV/r100 | EXPERIMENTAL | Fosamprenavir/ritonavir 1400/100mg QD |
| Name | Type | Description |
|---|---|---|
| Half-boosted Fosamprenavir | DRUG | Once daily, reduced dose ritonavir-boosted fosamprenavir |
| Full Boosted Fosamprenavir | DRUG | Full ritonavir-boosted fosamprenavir |
Inclusion criteria: * Subjects with HIV-1 infection. * Are willing and able to understand and provide written consent prior to participation in this study. Exclusion criteria: * Are pregnant or breastfeeding. * Have an active AIDS condition, pancreatitis, poor kidney function, or clinically relev...
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Half-boosted Fosamprenavir is an investigational small molecule being studied for the treatment of HIV infection. It is currently in Phase 3 clinical development, though the single trial evaluating it has been completed. The drug is intended for use in HIV-infected patients as part of an antiretroviral regimen.
Half-boosted Fosamprenavir is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research to evaluate this investigational drug for the treatment of HIV infection.
Half-boosted Fosamprenavir is in Phase 3 clinical development. The Phase 3 trial, identified as NCT00363142, has been completed. As an investigational drug, it has not yet been approved by regulatory authorities and remains under clinical evaluation for HIV infection.
Half-boosted Fosamprenavir has one completed Phase 3 clinical trial, NCT00363142, titled "A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects." This randomized, active-controlled trial enrolled 211 participants with HIV infection across the United States and Puerto Rico.
Half-boosted Fosamprenavir is not FDA approved. It is an investigational drug that has completed a Phase 3 clinical trial but remains in clinical development. The completed trial, NCT00363142, was designed to evaluate the drug in combination with FDA-approved HIV medications for the treatment of HIV infection.