drugset / Trial / NCT03369327
Sofosbuvir and Daclatasvir for Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus
Phase 3
Completed
232 enrolled
Tehran University of Medical Sciences
RojanPharma Pharmaceutical Company · collab
NaSingle-groupOpen-labelTreatment
Summary
In a multi-center study 200 patients co-infected with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) will be treated with a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular antiretroviral treatment (ART) being used by the patient. The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.
Timeline
- Start
- 2017-01-01
- Primary completion
- 2018-09-01
- Completion
- 2018-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daclatasvir | Small molecule | 30 mg | — |
| Subject | Daclatasvir | Small molecule | 60 mg | — |
| Subject | Daclatasvir | Small molecule | 90 mg | — |
| Subject | Sofosbuvir | Small molecule | 400 mg | — |