Overview
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.
Description
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）.
Eligibility
Inclusion Criteria:
- age≥18 years (including the critical value) when signed the informed consent form ,.male or female.
- Untreated, confirmed HIV-1 infected patients;
- HIV RNA viral load≥1000 copies/mL；
- CD4+ T cell counts≥200 cells/mm3；
- 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;
- 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:
- Subjects with an allergy history or hypersensitivity to any component or excipient of the investigational drug;
- Subjects with severe opportunistic infections or opportunistic tumors;
- Subjects with confirmed AIDS or in the acute infection stage;
- Hepatitis B virus surface antigen (HBsAg)/hepatitis C virus antibody (HCV-Ab) Positive;
- ALT and/or AST≥5×ULN；
- ALT≥3×ULN and total bilirubin≥2×ULN (direct bilirubin/total bilirubin>35%;
- GFR<70ml/min/1.73m2 (estimated from creatinine values based on the CKD-EPI Creatinine 2009 Equation), or creatinine ≥ULN;
- Subjects with severe and uncontrolled chronic diseases, metabolic diseases, neurological and psychiatric diseases;
- Subjects with a pancreatitis disease history ever before;
- Subjects who are pregnant or lactating women;
- Subjects with a history of drug abuse, alcoholism, or substance misuse;
- 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.