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

NCT04303598 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2020-03-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Henan Genuine Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2022-05-01
Completion
2022-08-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04303598 on ClinicalTrials.gov