drugset / Trial / NCT04155554
Neurological Monitoring in Patients Switching From Dolutegravir Based Regimen to Bictegravir Based Regimen
Phase 3
Unknown
100 enrolled
University Hospital of Siena
Azienda Ospedaliera San Paolo · collabCatholic University of the Sacred Heart · collabOspedale Amedeo di Savoia · collabOspedale Policlinico San Martino · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit. The hypothesis of the present study is that bictegravir is associated with a lower incidence and severity of neuropsychiatric symptoms than dolutegravir.
Timeline
- Start
- 2020-01-29
- Primary completion
- 2020-08
- Completion
- 2021-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abacavir | Other / unclassified | 600 mg | — |
| Comparator | Dolutegravir | Other / unclassified | 50 mg | — |
| Comparator | Lamivudine | Other / unclassified | 300 mg | — |
| Subject | bictegravir | Small molecule | 50 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 200 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 25 mg | Oral |