drugset / Trial / NCT04303598
Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients
RandomizedParallel-groupDouble-blindTreatment
Summary
Azvudine,(FNC), new nuclear nucleoside reverse transcriptase inhibitors, FNC make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance, approved by state drug administration (NMPA) for clinical research. FNC has completed its phase I、II clinical studies with desirable results.This is a multi-center, randomized, double-blind,double-placebo,active-control clinical trial. Subjects in experimental arm receives FNC+TDF+EFV+3TC placebo, while the subjected in active control arm receives 3TC+TDF+EFV+FNC placebo. The background drugs in both arms are conducted in open-label design while FNC and 3TC are conducted in double-blinded design.
Timeline
- Start
- 2020-04-01
- Primary completion
- 2022-05-01
- Completion
- 2022-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azvudine | Small molecule | 3 mg | Oral |
| Comparator | Lamivudine | Other / unclassified | 300 mg | Oral |
| Background | Efavirenz | Other / unclassified | 200 mg | Oral |
| Background | Tenofovir | Small molecule | 300 mg | Oral |