Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02431247 | A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects | PHASE3 | COMPLETED | 725 | — | — | Jul 6, 2015 | Sep 30, 2020 | Sep 28, 2022 | 80 | United States, Belgium +8 |
Percentage of participants with a HIV-1 RNA \< 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA \< 20/50/200 copies per mL at Week 48), 2) virologic failure (HIV RNA greater than or equal to \[\>=\] 20/50/200 copies per mL at Week 48), 3) no viral load data in the Week 48 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response.
| Arm | Type | Description |
|---|---|---|
| Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide | EXPERIMENTAL | Subject will receive a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination \[FDC\]) once daily along with DRV/COBI FDC-matching and FTC/TDF FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (i.e. after last subject has reached Week 48). After Week 48 analysis unblinding visit, subjects will receive a single tablet containing D/C/F/TAF FDC once daily up to Week 96. |
| DRV/COBI fixed dose combination (FDC) and FTC/TDF FDC | ACTIVE_COMPARATOR | Subject will receive DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding (i.e. after last subject has reached Week 48). After Week 48 analysis unblinding, subjects will receive a single tablet containing D/C/F/TAF FDC once daily up to Week 96. |
| Name | Type | Description |
|---|---|---|
| Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC | DRUG | A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF) 10 mg will be administered once daily. |
| DRV/COBI FDC | DRUG | A tablet containing DRV 800 mg and COBI 150 mg will be administered once daily. |
| FTC/TDF FDC | DRUG | A tablet containing FTC 200 mg and TDF 300 mg will be administered once daily. |
| D/C/F/TAF FDC - Matching Placebo | DRUG | Matching placebo of D/C/F/TAF FDC will be administered once daily. |
| FTC/TDF FDC Matching Placebo | DRUG | Matching placebo of FTC/TDF FDC will be administered once daily. |
| DRV/COBI FDC Matching Placebo | DRUG | Matching placebo of DRV/COBI FDC will be administered once daily. |
Inclusion Criteria: * Subject must be antiretroviral (ARV) treatment-naive (never treated with an ARV including post-exposure prophylaxis and pre-exposure prophylaxis); no prior use of any approved or experimental anti- human immunodeficiency virus (anti-HIV) drug for any length of time * Screening...