drugset / Trial / NCT04303598

Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients

NCT04303598

Phase 3 Unknown 720 enrolled Henan Genuine Biotech Co., Ltd.
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

EvaluationDrugModalityDoseRoute
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