AIDS Clinical Trial
Official title:
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
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 .
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.
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