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

Study Overview
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Brief Summary
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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.

Detailed Description
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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）.

Official Title
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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.

Conditions
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HIV

Intervention / Treatment
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* Drug: Lipovirtide 10mg
* Drug: Lipovirtide 40mg
* Drug: Lipovirtide 60mg
* Drug: DTG


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A：Lipovirtide 10mg+3TC+TDF<br>Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily） | Drug: Lipovirtide 10mg<br>* Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）；<br>* Other names: TDF;|
| Experimental: Group B：Lipovirtide 40mg+3TC+TDF<br>Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily） | Drug: Lipovirtide 40mg<br>* Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）；<br>* Other names: TDF;|
| Experimental: Group C：Lipovirtide 60mg+3TC+TDF<br>Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily） | Drug: Lipovirtide 60mg<br>* Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily）；<br>* Other names: TDF;|
| Experimental: Group D：DTG +3TC + TDF<br>DTG +3TC + TDF（once daily） | Drug: DTG<br>* DTG +3TC + TDF（once daily）.<br>* Other names: TDF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV-1 RNA <50 copies/ml | The proportion of subjects with HIV-1 RNA <50 copies/ml at Day 169 after receiving Lipovirtide administration. | at Day 169 after receiving Lipovirtide administration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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) | Within Day 169 of after receiving Lipovirtide administration | 
| HIV-1 RNA | The temporal changes in log-transformed HIV-1 RNA levels compared to baseline | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in respiration rate of Vital Signs | Respiration rate in times / minute | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in blood pressure of Vital Signs | Blood pressure in mmHg | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in body temperature of Vital Signs | Body temperature in Celsius degree | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in ECG PR intervalThe cardiac rhythm is showed in 12 Leads | Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded. | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in ECG QRS intervalThe cardiac rhythm is showed in 12 Leads | Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in ECG QT intervalThe cardiac rhythm is showed in 12 Leads | Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in Blood lactate of Laboratory Examination | Changes of blood lactate will be recorded | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in Pregnancy test of Laboratory Examination | Pregnancy test will be tested in female subjects | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in red blood cell count of Laboratory Examination | Red blood cell count in whole blood is reported in the form of number | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in white blood cell count of Laboratory Examination | White blood cell count in whole blood is reported in the form of number | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in neutrophil count of Laboratory Examination | Neutrophil count in whole blood is reported in the form of number | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in lymphocyte count of Laboratory Examination | Lymphocyte count in whole blood is reported in the form of number | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in platelet count of Laboratory Examination | Platelet count in whole blood is reported in the form of number. | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in hemoglobin of Laboratory Examination | Changes of hemoglobin concentration（g/dL）in whole blood will be recorded. | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in PT of Laboratory Examination | Prothrombin time (PT) is a screening test for exogenous coagulation factors | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in INR of Laboratory Examination | International standardized ratio (INR) is calculated from prothrombin time and international sensitivity index (ISI) of the reagent | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in APTT of Laboratory Examination | Changes of total bilirubin concentration (μmol/L) in serum will be recorded | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in direct bilirubin of Laboratory Examination | Changes of direct bilirubin concentration (μmol/L) in serum will be recorded. | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in ALT of Laboratory Examination | Changes of ALT concentration (U/L) in serum will be recorded | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in AST of Laboratory Examination | Changes of AST concentration (U/L) in serum will be recorded | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in total protein of Laboratory Examination. | Changes of total protein concentration (g/L) in serum will be recorded. | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in albumin of Laboratory Examination | Changes of albumin concentration (g/L) in serum will be recorded | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in creatinine of Laboratory Examination | Changes of creatinine concentration (μmol/L) in serum will be recorded | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in glucose of Laboratory Examination | Changes of glucose concentration (mmol/L) in serum will be recorded. | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in potassium of Laboratory Examination | Changes of potassium concentration (mmol/L) in serum will be recorded | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in sodium of Laboratory Examination | Changes of sodium concentration (mmol/L) in serum will be recorded | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in chlorine of Laboratory Examination | Changes of chlorine concentration (mmol/L) in serum will be recorded | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in urine specific gravity of Laboratory Examination | Changes of urine specific gravity will be recorded. | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in urine pH of Laboratory Examination | Changes of urine pH value will be recorded | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in urine glucose of Laboratory Examination | Changes of urine glucose will be examined by qualitative test (positive or negative | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in urine protein of Laboratory Examination | Changes of urine protein will be examined by qualitative test (positive or negative | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in urine ketone body of Laboratory Examination | Changes of urine ketone body will be examined by qualitative test (positive or negative). | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in urine white blood cell of Laboratory Examination | Changes of white blood cell in urine will be examined by qualitative test (positive or negative). | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in urine occult blood of Laboratory Examination. | Changes of urine occult blood will be examined by qualitative test (positive or negative) | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in LDH of Laboratory Examination | Changes of LDH concentration (U/L) in serum will be recorded. | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in Triglyceride of Laboratory Examination | Changes of Triglyceride concentration (mmol/L) in serum will be recorded | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in ALP of Laboratory Examination | Changes of ALP concentration (U/L) in serum will be recorded | Within Day 169 of after receiving Lipovirtide administration | 
| Changes from baseline in CHOL of Laboratory Examination | Changes of CHOL concentration (mmol/L) in serum will be recorded | Within Day 169 of after receiving Lipovirtide administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipovirtide, HIV, nucleoside drugs