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

Sponsor

HeNan Sincere Biotech Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT04109183

Collaborator

Beijing YouAn Hospital (Other), Peking Union Medical College Hospital (Other), Beijing Ditan Hospital (Other), Guangzhou 8th People's Hospital (Other), The Sixth People's Hospital of Zhengzhou (Other)

172

Enrollment

Location

Arms

16.8

Actual Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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 .

Condition or Disease	Intervention/Treatment	Phase
AIDS	Drug: The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

172 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

a multicenter, randomized, double-blind, double-simulation, positive control trial.a multicenter, randomized, double-blind, double-simulation, positive control trial.

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

This experiment used a block randomization method, and each research center competed for inclusion. The SAS software (9.3 or above) was used to generate a random table and the corresponding treatment group for the random table. The clinical trial electronic central stochastic system (DAS for IWRS) was used to assign random numbers.Blind bottom sealed preservation, respectively sealed by the sponsor and clinical research unit.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 10, 2017

Actual Primary Completion Date :

Jan 28, 2019

Actual Study Completion Date :

Mar 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Comparator: FNC 2 mg+ TDF+EFV	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.
Experimental: Active Comparator: FNC 3 mg+ TDF+EFV	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.
Experimental: Active Comparator: FNC 4 mg+ TDF+EFV	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.
Experimental: Postive Comparator: 3TC+ TDF+EFV	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.

Outcome Measures

Primary Outcome Measures

Evaluation of azivudine tablet (FNC) combined with reverse transcriptase inhibitor therapy without anti-hiv treatment. [At 48 weeks]
Number of subjects with HIV viral load < 50copies/ml after treatment
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. [At 48 weeks]
Number of subjects with HIV viral load < 50copies/ml after treatment

Secondary Outcome Measures

To explore the effective dose of azivudine tablet (FNC) in clinic [At 48 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing YouAn Hospital, Capital Medical University.	Beijing	Beijing	China	10000

Sponsors and Collaborators

HeNan Sincere Biotech Co., Ltd
Beijing YouAn Hospital
Peking Union Medical College Hospital
Beijing Ditan Hospital
Guangzhou 8th People's Hospital
The Sixth People's Hospital of Zhengzhou

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

HeNan Sincere Biotech Co., Ltd

ClinicalTrials.gov Identifier:

NCT04109183

Other Study ID Numbers:

GQ-FNC-201

First Posted:

Sep 30, 2019

Last Update Posted:

Sep 30, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by HeNan Sincere Biotech Co., Ltd

HIV/AIDS

Study Results

No Results Posted as of Sep 30, 2019