Status:
COMPLETED
A Drug Safety and Dose-exploratory Clinical Study of Azvudine Tablets in Patients Who Have Not Received Anti-HIV Treatment
Lead Sponsor:
Henan Genuine Biotech Co., Ltd.
Collaborating Sponsors:
Beijing YouAn Hospital
Peking Union Medical College Hospital
Conditions:
AIDS
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 pati...
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 Nat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2019
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT04109183
Start Date
October 10 2017
End Date
March 6 2019
Last Update
September 30 2019
Active Locations (1)
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1
Beijing YouAn Hospital, Capital Medical University.
Beijing, Beijing Municipality, China, 10000