Completed
FNC

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

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What is being tested

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

Drug
Who is being recruted

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2017
See protocol details

Summary

Principal SponsorHeNan Sincere Biotech Co., Ltd
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 10, 2017Actual date on which the first participant was enrolled.

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.

Official TitleA 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 
NCT04109183
Principal SponsorHeNan Sincere Biotech Co., Ltd
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
172 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Criteria

Inclusion Criteria: 1.18-65 years old, regardless of gender; 2.Confirmed HIV positive with a report; 3.Have not received anti-hiv antiviral treatment; 4.HIV viral load ≥1000 copies/mL; 5.Who have no recent family planning and agree to take effective non-drug contraceptive measures during the trial period and within 3 months after the end of administration; 6.The subjects could fully understand the purpose, nature, method and possible adverse reactions of the test, and voluntarily participate in and sign the informed consent. Exclusion Criteria: 1. Patients who have received anti-HIV treatment; 2. Suffering from a serious opportunistic infection or opportunistic tumor; 3. Abnormal blood routine examination (white blood cells \<3 × 109 / L, hemoglobin \<90g / L, neutrophils \<1.5 × 109 / L, platelets \<75 × 109 / L); 4. Have a definite liver disease (hepatitis B surface antigen/HCV antibody positive), or abnormal liver function test (alanine aminotransferase and/or aspartate aminotransferase exceeds the upper limit of normal value by 3 times, or total bilirubin exceeds the upper limit of normal value 2 times); 5. Renal insufficiency (glomerular filtration rate \<70ml/min, or creatinine above the upper limit of normal); 6. Now suffering from more serious chronic diseases, metabolic diseases (such as diabetes), neurological and psychiatric diseases; 7. Has suffered from pancreatitis; 8. Women during pregnancy and lactation; 9. allergic constitution or known to be allergic to the pharmaceutical ingredients and the basic drugs prescribed in this program; 10. Suspect or determine the history of alcohol and drug abuse; 11. Participated in other drug clinical trials (excluding Chinese medicine) within the first three months of screening; 12. Other factors that are not suitable for entering the trial.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
4 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental

The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.
Group II
Experimental

The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.
Group III
Experimental

The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.
Group IV
Experimental

The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.
Study Objectives
Primary Objectives

Number of subjects with HIV viral load \< 50copies/ml after treatment

Number of subjects with HIV viral load \< 50copies/ml after treatment
Secondary Objectives

Changes in HIV load logarithm before and after treatment, including the number of subjects whose HIV load level decreased by ≥1log from baseline before and after treatment;CD4 cell count before and after treatment

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Beijing YouAn Hospital, Capital Medical University.Beijing, ChinaSee the location
CompletedOne Study Center
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