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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01106586 | Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults | PHASE3 | COMPLETED | 708 | — | — | Apr 1, 2010 | Sep 1, 2014 | Nov 11, 2015 | 146 | United States, Australia +15 |
| NCT01095796 | Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults | PHASE3 | COMPLETED | 707 | — | — | Mar 1, 2010 | Sep 1, 2014 | Nov 11, 2015 | 102 | United States, Puerto Rico |
| NCT00869557 | Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults | PHASE2 | COMPLETED | 71 | — | — | Apr 1, 2009 | Sep 1, 2013 | Jun 4, 2014 | 30 | United States |
The percentage of participants with plasma HIV-1 RNA \< 50 copies/mL at Week 24 was summarized.
| Arm | Type | Description |
|---|---|---|
| Stribild | EXPERIMENTAL | - |
| ATV/r + FTC/TDF | ACTIVE_COMPARATOR | - |
| Atripla | ACTIVE_COMPARATOR | Atripla plus placebo to match Stribild |
| Name | Type | Description |
|---|---|---|
| Stribild | DRUG | Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily |
| ATV | DRUG | Atazanavir 300 mg capsule administered orally once daily |
| Ritonavir | DRUG | Ritonavir (RTV; /r) 100 mg tablet administered orally once daily |
| FTC/TDF | DRUG | FTC/TDF 200/300 mg tablet administered orally once daily |
| Stribild Placebo | DRUG | Placebo to match Stribild administered orally once daily |
| ATV Placebo | DRUG | Placebo to match ATV administered orally once daily |
| RTV Placebo | DRUG | Placebo to match RTV administered orally once daily |
| FTC/TDF Placebo | DRUG | Placebo to match FTC/TDF administered orally once daily |
| Atripla | DRUG | Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet administered orally once daily prior to bedtime |
| Atripla Placebo | DRUG | Placebo to match Atripla tablet administered orally once daily prior to bedtime |
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 ...