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| Name | Class |
|---|---|
| Institute of Pathogen Biology, Beijing, China | OTHER |
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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.
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）.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A：Lipovirtide 10mg+3TC+TDF | Experimental | Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily） |
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| Group B：Lipovirtide 40mg+3TC+TDF | Experimental | Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily） |
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| Group C：Lipovirtide 60mg+3TC+TDF | Experimental | Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily） |
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| Group D：DTG +3TC + TDF | Experimental | DTG +3TC + TDF（once daily） |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipovirtide 10mg | Drug | Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）； |
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| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ping Ma, Doctor | Tianjin Second People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Second People's Hospital | Tianjin | Tianjin Municipality | 300000 | China |
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| Lipovirtide 40mg | Drug | Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）； |
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| Lipovirtide 60mg | Drug | Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily）； |
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| DTG | Drug | DTG +3TC + TDF（once daily）. |
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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 |