| Company Name | GSK |
|---|---|
| Protocol Number | 217478 |
| Title of Study | A Phase IV, Prospective, Non-Interventional Cohort Study of Fostemsavir Based Regimen In Heavily Treatment Experienced Patient With Hiv-1 Infection In Taiwan |
| Primary Objective | This phase IV post marketing study is a post-approval commitment for fostemsavir authorization in Taiwan, aiming to provide additional efficacy and safety information for Taiwan Food and Drug Administration (TFDA) and CDE to evaluate ethnosensitivity in the Asian population. The primary endpoint is the number achieving virological suppression (plasma HIV-1 RNA <50 copies/mL) viral load at week 24 (+/-12 weeks). |
| Number of Sites | (Estimated) 5-6 |
| Period of Study | From：2022/09/18 to：2027/09/17 |
| Number of Patients | (Estimated) 5-10人 |
| IRB Approval Date | NTUH - Pending for approval |
| Publication Plan / Date | Not yet confirmed |
