Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients

A Randomized, Double-blind, Double-simulated, Active-controlled，Phase III Clinical Study Evaluating the Efficacy and Safety of Azvudine Combined With Tenofovir Fumarate and Efavirenz in Hiv-infected Treatment Naive Patients

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, approved by state drug administration (NMPA) for clinical research. FNC has completed its phase I、II clinical studies with desirable results.This is a multi-center, randomized, double-blind,double-placebo,active-control clinical trial. Subjects in experimental arm receives FNC+TDF+EFV+3TC placebo, while the subjected in active control arm receives 3TC+TDF+EFV+FNC placebo. The background drugs in both arms are conducted in open-label design while FNC and 3TC are conducted in double-blinded design.

Inclusion Criteria:

1. 18-65 years old, regardless of gender;
2. Participant must have an positive HIV test;
3. Have not received anti-HIV treatment;
4. HIV-1 RNA≥1000 copies/ml and the investigators determined that the subjects were eligible for HAART therapy.
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. History of allergy to any ingredient or excipient of the research drug or have a high sensitivity constitution;
2. Patients with severe opportunistic infection or tumor;
3. Clinically Hepatitis b surface antigen/hepatitis c antibody positive;
4. Clinically Alanine transaminase and/or alanine transaminase ≥5× normal upper limit (ULN);
5. Clinically Alanine aminotransferase ≥3×ULN and total bilirubin ≥2×ULN (direct bilirubin/total bilirubin > 35%);
6. Glomerular filtration rate < 70ml/min/1.73m2 (calculated by ckd-epi Creatinine 2009 Equation), or Creatinine ≥ULN;
7. Clinically significant diseases serious chronic diseases , metabolic diseases (such as diabetes), neurological and psychiatric diseases;
8. History of pancreatitis;
9. Women in pregnancy and breastfeeding;
10. History of drug abuse, alcohol abuse and drug abuse;
11. Participating in clinical trials of other drugs within the first three months of screening;
12. Other factors considered inappropriate by the investigator to be included in the study