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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01108510 | Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults | PHASE3 | COMPLETED | 698 | — | — | Apr 1, 2010 | Apr 1, 2015 | May 23, 2016 | 134 | United States, Australia +17 |
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.
| Arm | Type | Description |
|---|---|---|
| ATV+COBI+FTC/TDF | EXPERIMENTAL | COBI + RTV placebo + ATV + FTC/TDF once daily |
| ATV+RTV+FTC/TDF | ACTIVE_COMPARATOR | RTV + COBI placebo + ATV + FTC/TDF once daily |
| Name | Type | Description |
|---|---|---|
| COBI | DRUG | Cobicistat (COBI) 150 mg tablet administered orally once daily |
| RTV | DRUG | Ritonavir (RTV) 100 mg tablet administered orally once daily |
| ATV | DRUG | Atazanavir (ATV) 300 mg capsule administered orally once daily |
| FTC/TDF | DRUG | Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily |
| COBI placebo | DRUG | Placebo to match COBI administered orally once daily |
| RTV placebo | DRUG | Placebo to match RTV administered orally once daily |
Inclusion Criteria: * Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * Plasma HIV-1 RNA levels ≥ 5,000 copies/mL at screening * No prior use of any approved or investigational antiretroviral drug for any length of time ...