Status:
UNKNOWN
Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients
Lead Sponsor:
Henan Genuine Biotech Co., Ltd.
Conditions:
HIV-infection/Aids
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Azvudine,(FNC)， new nuclear nucleoside reverse transcriptase inhibitors, FNC make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance, appro...
Eligibility Criteria
Inclusion
- 18-65 years old, regardless of gender;
- Participant must have an positive HIV test;
- Have not received anti-HIV treatment;
- HIV-1 RNA≥1000 copies/ml and the investigators determined that the subjects were eligible for HAART therapy.
- 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;
- 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
- History of allergy to any ingredient or excipient of the research drug or have a high sensitivity constitution;
- Patients with severe opportunistic infection or tumor;
- Clinically Hepatitis b surface antigen/hepatitis c antibody positive;
- Clinically Alanine transaminase and/or alanine transaminase ≥5× normal upper limit (ULN);
- Clinically Alanine aminotransferase ≥3×ULN and total bilirubin ≥2×ULN (direct bilirubin/total bilirubin \> 35%);
- Glomerular filtration rate \< 70ml/min/1.73m2 (calculated by ckd-epi Creatinine 2009 Equation), or Creatinine ≥ULN;
- Clinically significant diseases serious chronic diseases , metabolic diseases (such as diabetes), neurological and psychiatric diseases;
- History of pancreatitis;
- Women in pregnancy and breastfeeding;
- History of drug abuse, alcohol abuse and drug abuse;
- Participating in clinical trials of other drugs within the first three months of screening;
- Other factors considered inappropriate by the investigator to be included in the study
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT04303598
Start Date
April 1 2020
End Date
August 1 2022
Last Update
March 11 2020
Active Locations (12)
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1
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100001
2
Beijing DiTan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
3
Chongqing Public Health Medical Center
Chongqing, Chongqing Municipality, China
4
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, China