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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01565850 | D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults | PHASE2 | COMPLETED | 153 | — | — | Apr 1, 2012 | Feb 1, 2014 | Apr 11, 2016 | 44 | United States, Puerto Rico |
The 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, along with study drug discontinuation status.
| Arm | Type | Description |
|---|---|---|
| D/C/F/TAF | EXPERIMENTAL | D/C/F/TAF FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo |
| DRV+COBI+FTC/TDF | ACTIVE_COMPARATOR | DRV tablet plus COBI tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo |
| Name | Type | Description |
|---|---|---|
| D/C/F/TAF | DRUG | DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg FDC tablet administered orally once daily |
| DRV | DRUG | DRV 800 mg (2 × 400 mg tablets) administered orally once daily |
| COBI | DRUG | COBI 150 mg tablet administered orally once daily |
| FTC/TDF | DRUG | FTC 200 mg/TDF 300 mg FDC tablet administered orally once daily |
| D/C/F/TAF Placebo | DRUG | D/C/F/TAF placebo tablet administered orally once daily |
| DRV Placebo | DRUG | DRV placebo tablet administered orally once daily |
| COBI Placebo | DRUG | COBI placebo tablet administered orally once daily |
| FTC/TDF Placebo | DRUG | FTC/TDF placebo tablet administered orally once daily |
Inclusion Criteria: * Adult (≥ 18 years) males or non-pregnant females * Ability to understand and sign a written informed consent form * General medical condition which does not interfere with the assessments and the completion of the trial * Plasma HIV-1 RNA levels ≥ 5,000 copies/mL * CD4+ cell c...