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

Shanxi Kangbao Biological Product Co., Ltd.64 enrolled

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.

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）.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV

Interventions

Lipovirtide 10mgDRUG

Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）；

Lipovirtide 40mgDRUG

Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）；

Lipovirtide 60mgDRUG

Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily）；

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, China

Outcomes

Primary Outcomes

HIV-1 RNA <50 copies/ml

The proportion of subjects with HIV-1 RNA \<50 copies/ml at Day 169 after receiving Lipovirtide administration.

Time frame: at Day 169 after receiving Lipovirtide administration.

Secondary Outcomes

HIV-1 RNA <50 copies/ml

The proportion of subjects with HIV-1 RNA \<50 copies/ml at Day 29、Day 85、Day 169 after receiving Lipovirtide administration

Time frame: at Day 29、Day 85、Day 169 after receiving Lipovirtide administration

HIV-1 RNA <400 copies/ml

The proportion of subjects with HIV-1 RNA \<400 copies/ml at Day 85、Day 169 after receiving Lipovirtide administration

Time frame: at Day 85、Day 169 after receiving Lipovirtide administration

CD4+ T-cell and CD8+ T-cell

The changes in CD4+ T-cell and CD8+ T-cell counts compared to baseline at Day 85 and Day 169 after receiving Lipovirtide administration

Time frame: at Day 85 and Day 169 after receiving Lipovirtide administration

HIV-1 RNA <50 copies/ml

The time required to achieve viral suppression (HIV-1 RNA \<50 copies/ml)