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

HIV-infection/Aids Clinical Trial

Official title:
A Randomized, Double-blind, Double-simulated, Active-controlled，Phase III Clinical Study Evaluating the Efficacy and Safety of Azvudine Combined With Tenofovir Fumarate and Efavirenz in Hiv-infected Treatment Naive Patients

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04303598
Study type Interventional
Source HeNan Sincere Biotech Co., Ltd
Contact Wu Hao
Phone +86 13601242523
Email whdoc@sina.com
Status Not yet recruiting
Phase Phase 3
Start date April 1, 2020
Completion date August 1, 2022
View Details
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