NCT04109183

A Drug Safety and Dose-exploratory Clinical Study of Azvudine Tablets in Patients Who Have Not Received Anti-HIV Treatment

A Dose-exploratory Clinical Study of Azvudine Tablets in Patients Who Have Not Received Anti-HIV treatment--a Multicenter, Randomized, Double-blind, Double-simulation, Positive Control Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Henan Genuine Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial was to evaluate the safety and preliminary evaluation of Azvudine tablets (FNC) in combination with reverse transcriptase inhibitors therapy in treatment-naive patients with HIV infection.; the secondary objective is to explore the effective dose of clinical use of Azvudine (FNC) tablets .

Detailed description

Azvudine (FNC), a new class I drug with independent intellectual property rights, is a novel nucleoside reverse transcriptase inhibitor with good inhibitory activity against HIV-1 and obtained the National Medical Products Administration(NMPA) approved for clinical research. In this trial, 172 patients who had not received anti-HIV treatment were enrolled, including FNC4mg group, FNC3mg group, FNC2mg group, and 3TC control group, 43 cases, 5 research centers, and each research center was simultaneously engaged and competing. The enrolled subjects underwent 7 visits including baseline visits, and HIV -1RNA and CD4 cell counts were tested and statistically analyzed for each visit.

Conditions

• AIDS

Interventions

Type	Name	Description
DRUG	The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.	The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.

Timeline

• Start date: 2017-10-10
• Primary completion: 2019-01-28
• Completion: 2019-03-06
• First posted: 2019-09-30
• Last updated: 2019-09-30

Locations

1 site across 1 country: China