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PI · 1 trial · 2 indications
The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
| Arm | Type | Description |
|---|---|---|
| Stribild | EXPERIMENTAL | Participants will switch from their baseline treatment regimen to Stribild for up to 96 weeks, and may continue to receive Stribild in the extension phase. |
| PI+RTV+FTC/TDF | ACTIVE_COMPARATOR | Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of a PI boosted with RTV plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase. |
| Name | Type | Description |
|---|---|---|
| PI | DRUG | PI administered according to prescribing information; allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV) |
| RTV | DRUG | RTV administered according to prescribing information FTC/TDF administered according to prescribing information |
| FTC/TDF | DRUG | FTC/TDF (200/300 mg) administered according to prescribing information |
| Stribild | DRUG | Stribild (E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food |
Inclusion Criteria: * Ability to understand and sign a written informed consent form * Be on a stable antiretroviral regimen consisting of a ritonavir boosted PI plus FTC/TDF continuously for ≥ 6 consecutive months preceding the screening visit * Be on the first or second antiretroviral drug regime...
PI is an investigational small molecule being studied for the treatment of Acquired Immunodeficiency Syndrome (AIDS) and HIV infections. It is being developed by Gilead Sciences, Inc. (GILD) and is currently in Phase 3 clinical development.
PI is a protease inhibitor, a class of antiretroviral drugs that work by blocking the protease enzyme, which HIV needs to replicate. By inhibiting this enzyme, PI helps reduce the viral load in patients with HIV infection.
PI is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. Gilead is conducting clinical trials to evaluate the safety and efficacy of PI in patients with HIV.
PI is currently in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. A Phase 3 trial has been completed to evaluate its efficacy and safety in virologically suppressed HIV-1 infected patients.
PI has been studied in a completed Phase 3 clinical trial with the identifier NCT01475838. This trial enrolled 438 participants and evaluated switching from a ritonavir-boosted protease inhibitor regimen to a single-tablet regimen containing elvitegravir, cobicistat, emtricitabine, and tenofovir DF in virologically suppressed HIV-1 infected patients.
PI is not the same as the combination product elvitegravir/cobicistat/emtricitabine/tenofovir DF. In the clinical trial NCT01475838, PI was studied as a comparator, and the trial evaluated switching from a PI-based regimen to the elvitegravir-containing single-tablet regimen.