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

HeNan Sincere Biotech

Status and phase: Completed; Phase 2

Conditions: AIDS

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04109183

GQ-FNC-201

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 172 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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172 participants in 4 patient groups

Active Comparator: FNC 2 mg+ TDF+EFV

Experimental group

Treatment:

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

Active Comparator: FNC 3 mg+ TDF+EFV

Experimental group

Treatment:

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

Active Comparator: FNC 4 mg+ TDF+EFV

Experimental group

Treatment:

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

Postive Comparator: 3TC+ TDF+EFV

Experimental group

Treatment:

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