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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01721109 | Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents | PHASE2 | COMPLETED | 50 | — | — | Dec 6, 2012 | Jan 29, 2018 | Aug 17, 2018 | 18 | United States, South Africa +1 |
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
| Arm | Type | Description |
|---|---|---|
| EVG/COBI/FTC/TDF | EXPERIMENTAL | Participants will receive treatment for 48 weeks and then had the option to enter an Extension Phase to receive EVG/COBI/FTC/TDF until 1) the age of 18, 2) EVG/COBI/FTC/TDF becomes commercially available in the country the participant is enrolled, or 3) Gilead elects to terminate the development of EVG/COBI/FTC/TDF in that country. |
| Name | Type | Description |
|---|---|---|
| EVG/COBI/FTC/TDF | DRUG | 150/150/200/300 mg STR administered orally once daily with food |
Key Inclusion Criteria: * 12 years to \< 18 years of age at baseline * Able to give written assent prior to any screening evaluations * Parent or guardian able to give written informed consent prior to any screening evaluations and willing to comply with study requirements * Plasma HIV-1 RNA levels...