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

Study Overview
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Brief Summary
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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
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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 Title
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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

Conditions
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AIDS

Intervention / Treatment
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* Drug: The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.


Participation Criteria
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Eligibility Criteria
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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: Patients who have received anti-HIV treatment; Suffering from a serious opportunistic infection or opportunistic tumor; Abnormal blood routine examination (white blood cells <3 × 109 / L, hemoglobin <90g / L, neutrophils <1.5 × 109 / L, platelets <75 × 109 / L); 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); Renal insufficiency (glomerular filtration rate <70ml/min, or creatinine above the upper limit of normal); Now suffering from more serious chronic diseases, metabolic diseases (such as diabetes), neurological and psychiatric diseases; Has suffered from pancreatitis; Women during pregnancy and lactation; allergic constitution or known to be allergic to the pharmaceutical ingredients and the basic drugs prescribed in this program; Suspect or determine the history of alcohol and drug abuse; Participated in other drug clinical trials (excluding Chinese medicine) within the first three months of screening; Other factors that are not suitable for entering the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a multicenter, randomized, double-blind, double-simulation, positive control trial.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Comparator: FNC 2 mg+ TDF+EFV<br> | Drug: The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.<br>* The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.<br>|
| Experimental: Active Comparator: FNC 3 mg+ TDF+EFV<br> | Drug: The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.<br>* The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.<br>|
| Experimental: Active Comparator: FNC 4 mg+ TDF+EFV<br> | Drug: The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.<br>* The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.<br>|
| Experimental: Postive Comparator: 3TC+ TDF+EFV<br> | Drug: The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.<br>* The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of azivudine tablet (FNC) combined with reverse transcriptase inhibitor therapy without anti-hiv treatment. | Number of subjects with HIV viral load < 50copies/ml after treatment | At 48 weeks | 
| Preliminary evaluation of the efficacy of azivudine tablets (FNC) combined with reverse transcriptase inhibitors in the treatment of patients who have not received anti-hiv treatment. | Number of subjects with HIV viral load < 50copies/ml after treatment | At 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the effective dose of azivudine tablet (FNC) in clinic | 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 | At 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/AIDS