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NNRTI · 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. |
| NNRTI+FTC/TDF | ACTIVE_COMPARATOR | Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of an NNRTI plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase. |
| Name | Type | Description |
|---|---|---|
| NNRTI | DRUG | NNRTI agents administered according to prescribing information; allowed NNRTIs include efavirenz (EFV), nevirapine, or rilpivirine. |
| FTC/TDF | DRUG | FTC/TDF (200/300 mg) administered according to prescribing information |
| Stribild | DRUG | Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; 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 stable on the current formulation(s) of an antiretroviral regimen consisting of an NNRTI plus FTC/TDF for ≥ 6 consecutive months preceding the screening visit. This includes those who began a regimen with indi...
NNRTI is an investigational small molecule being developed for the treatment of Acquired Immunodeficiency Syndrome (AIDS) in patients with HIV infections. It is currently in Phase 3 clinical development.
NNRTI is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD.
NNRTI is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities.
NNRTI has been studied in one completed Phase 3 clinical trial, NCT01495702, which enrolled 439 participants. The trial evaluated switching from regimens consisting of a nonnucleoside reverse transcriptase inhibitor plus emtricitabine and tenofovir DF to the elvitegravir/cobicistat/emtricitabine/tenofovir DF single-tablet regimen in virologically suppressed, HIV-1 infected patients.
NNRTI is not the same as elvitegravir/cobicistat/emtricitabine/tenofovir DF. The clinical trial NCT01495702 compared a regimen containing a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus emtricitabine and tenofovir DF to the elvitegravir/cobicistat/emtricitabine/tenofovir DF single-tablet regimen.