NCT04303598

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Henan Genuine Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-infection/Aids

Interventions

Type	Name	Description
DRUG	FNC	3mg, 1 tablet，QD
DRUG	3TC	300mg, 1 tablet，QD
DRUG	TDF	300mg, 1 tablet，QD
DRUG	EFV	200mg, 1 tablet，QD
DRUG	FNC placebo	1 tablet，QD
DRUG	3TC placebo	1 tablet，QD

Timeline

• Start date: 2020-04-01
• Primary completion: 2022-05-01
• Completion: 2022-08-01
• First posted: 2020-03-11
• Last updated: 2020-03-11

Locations

12 sites across 1 country: China