Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients.

A Randomized, Controlled, Open-label, Dose-exploration Study to Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients Who Have Not Received Antiviral Treatment Before.

A randomized, controlled, open-label, dose-exploration study to assess the effectiveness and safety of Lipovirtide combined with nucleoside drugs in HIV-infected patients who have not received antiviral treatment before.

multiple sites, randomized, open-label, controlled study design. 64 eligible subjects will be enrolled in this study, and they will be randomly assigned to each group in a 1:1:1:1 proportion, 16 subjects in each group. Each site will compete to enroll subjects.

The 4 groups are as follows： Group A：Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）； Group B：Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）； Group C：Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily）； Group D：DTG +3TC + TDF（once daily）.

Inclusion Criteria:

1. age≥18 years (including the critical value) when signed the informed consent form ,.male or female.
2. Untreated, confirmed HIV-1 infected patients;
3. HIV RNA viral load≥1000 copies/mL；
4. CD4+ T cell counts≥200 cells/mm3；
5. Subjects who have no plans for conception within the 2 weeks prior to screening and 3 months after the end of the trial, and who agree to use effective non-pharmacological contraceptive measures during the trial;
6. Sign informed consent prior to the test and fully understand the purpose, nature, methods, and possible adverse reactions, and be willing to participate in the study.

Exclusion Criteria:

1. Subjects with an allergy history or hypersensitivity to any component or excipient of the investigational drug;
2. Subjects with severe opportunistic infections or opportunistic tumors;
3. Subjects with confirmed AIDS or in the acute infection stage;
4. Hepatitis B virus surface antigen (HBsAg)/hepatitis C virus antibody (HCV-Ab) Positive;
5. ALT and/or AST≥5×ULN；
6. ALT≥3×ULN and total bilirubin≥2×ULN (direct bilirubin/total bilirubin>35%;
7. GFR<70ml/min/1.73m2 (estimated from creatinine values based on the CKD-EPI Creatinine 2009 Equation), or creatinine ≥ULN;
8. Subjects with severe and uncontrolled chronic diseases, metabolic diseases, neurological and psychiatric diseases;
9. Subjects with a pancreatitis disease history ever before;
10. Subjects who are pregnant or lactating women;
11. Subjects with a history of drug abuse, alcoholism, or substance misuse;
12. Any clinical trials in the 3 months prior to the screening of the trial; 13）Subjects may not be able to complete this study or other investigators' judgment for other reasons.