Clinical trial NCT04109183: A Drug Safety and Dose-exploratory Clinical Study of Azvudine Tablets in Patients Who Have Not Received Anti-HIV 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: AIDS
Keywords: HIV/AIDS
Lead sponsor: Henan Genuine Biotech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Beijing YouAn Hospital
name: Peking Union Medical College Hospital
name: Beijing Ditan Hospital
name: Guangzhou 8th People's Hospital
name: The Sixth People's Hospital of Zhengzhou
First posted: 2019-09-30
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a multicenter, randomized, double-blind, double-simulation, positive control trial.
Primary purpose: TREATMENT

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 .

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.

Eligibility 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.

Primary outcomes:
measure: Evaluation of azivudine tablet (FNC) combined with reverse transcriptase inhibitor therapy without anti-hiv treatment.
timeFrame: At 48 weeks
measure: 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.
timeFrame: At 48 weeks
Secondary outcomes:
measure: To explore the effective dose of azivudine tablet (FNC) in clinic
timeFrame: At 48 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing YouAn Hospital, Capital Medical University.
state: Beijing
Study officials:
References: