drugset / Trial / NCT04109183
A Drug Safety and Dose-exploratory Clinical Study of Azvudine Tablets in Patients Who Have Not Received Anti-HIV Treatment
Phase 2
Completed
172 enrolled
Henan Genuine Biotech Co., Ltd.
Beijing Ditan Hospital · collabBeijing YouAn Hospital · collabGuangzhou 8th People's Hospital · collabPeking Union Medical College Hospital · collabThe Sixth People's Hospital of Zhengzhou · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The primary objective of this trial was to evaluate the safety and preliminary evaluation of Azvudine tablets (FNC) in combination with reverse transcriptase inhibitors therapy in treatment-naive patients with HIV infection.; the secondary objective is to explore the effective dose of clinical use of Azvudine (FNC) tablets .
Timeline
- Start
- 2017-10-10
- Primary completion
- 2019-01-28
- Completion
- 2019-03-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azvudine | Small molecule | 2 mg | — |
| Subject | Azvudine | Small molecule | 3 mg | — |
| Subject | Azvudine | Small molecule | 4 mg | — |
| Subject | Lamivudine | Other / unclassified | — | — |
| Background | EFV | Unknown | — | — |
| Background | TDF | Unknown | — | — |