FNCA 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
The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: October 10, 2017
Actual 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.172 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
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
Beijing YouAn Hospital, Capital Medical University.
Beijing, ChinaOpen Beijing YouAn Hospital, Capital Medical University. in Google Maps