Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed 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）.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A：Lipovirtide 10mg+3TC+TDF Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily） |
Drug: Lipovirtide 10mg
Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）；
Other Names:
|
| Experimental: Group B：Lipovirtide 40mg+3TC+TDF Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily） |
Drug: Lipovirtide 40mg
Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）；
Other Names:
|
| Experimental: Group C：Lipovirtide 60mg+3TC+TDF Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily） |
Drug: Lipovirtide 60mg
Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily）；
Other Names:
|
| Experimental: Group D：DTG +3TC + TDF DTG +3TC + TDF（once daily） |
Drug: DTG
DTG +3TC + TDF（once daily）.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- HIV-1 RNA <50 copies/ml [at Day 169 after receiving Lipovirtide administration.]
The proportion of subjects with HIV-1 RNA <50 copies/ml at Day 169 after receiving Lipovirtide administration.
Secondary Outcome Measures
- HIV-1 RNA <50 copies/ml [at Day 29、Day 85、Day 169 after receiving Lipovirtide administration]
The proportion of subjects with HIV-1 RNA <50 copies/ml at Day 29、Day 85、Day 169 after receiving Lipovirtide administration
- HIV-1 RNA <400 copies/ml [at Day 85、Day 169 after receiving Lipovirtide administration]
The proportion of subjects with HIV-1 RNA <400 copies/ml at Day 85、Day 169 after receiving Lipovirtide administration
- CD4+ T-cell and CD8+ T-cell [at Day 85 and Day 169 after receiving Lipovirtide administration]
The changes in CD4+ T-cell and CD8+ T-cell counts compared to baseline at Day 85 and Day 169 after receiving Lipovirtide administration
- HIV-1 RNA <50 copies/ml [Within Day 169 of after receiving Lipovirtide administration]
The time required to achieve viral suppression (HIV-1 RNA <50 copies/ml)
- HIV-1 RNA [Within Day 169 of after receiving Lipovirtide administration]
The temporal changes in log-transformed HIV-1 RNA levels compared to baseline
- Changes from baseline in respiration rate of Vital Signs [Within Day 169 of after receiving Lipovirtide administration]
Respiration rate in times / minute
- Changes from baseline in blood pressure of Vital Signs [Within Day 169 of after receiving Lipovirtide administration]
Blood pressure in mmHg
- Changes from baseline in body temperature of Vital Signs [Within Day 169 of after receiving Lipovirtide administration]
Body temperature in Celsius degree
- Changes from baseline in ECG PR intervalThe cardiac rhythm is showed in 12 Leads [Within Day 169 of after receiving Lipovirtide administration]
Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.
- Changes from baseline in ECG QRS intervalThe cardiac rhythm is showed in 12 Leads [Within Day 169 of after receiving Lipovirtide administration]
Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded
- Changes from baseline in ECG QT intervalThe cardiac rhythm is showed in 12 Leads [Within Day 169 of after receiving Lipovirtide administration]
Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded
- Changes from baseline in Blood lactate of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of blood lactate will be recorded
- Changes from baseline in Pregnancy test of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Pregnancy test will be tested in female subjects
- Changes from baseline in red blood cell count of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Red blood cell count in whole blood is reported in the form of number
- Changes from baseline in white blood cell count of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
White blood cell count in whole blood is reported in the form of number
- Changes from baseline in neutrophil count of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Neutrophil count in whole blood is reported in the form of number
- Changes from baseline in lymphocyte count of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Lymphocyte count in whole blood is reported in the form of number
- Changes from baseline in platelet count of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Platelet count in whole blood is reported in the form of number.
- Changes from baseline in hemoglobin of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of hemoglobin concentration（g/dL）in whole blood will be recorded.
- Changes from baseline in PT of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Prothrombin time (PT) is a screening test for exogenous coagulation factors
- Changes from baseline in INR of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
International standardized ratio (INR) is calculated from prothrombin time and international sensitivity index (ISI) of the reagent
- Changes from baseline in APTT of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of total bilirubin concentration (μmol/L) in serum will be recorded
- Changes from baseline in direct bilirubin of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of direct bilirubin concentration (μmol/L) in serum will be recorded.
- Changes from baseline in ALT of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of ALT concentration (U/L) in serum will be recorded
- Changes from baseline in AST of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of AST concentration (U/L) in serum will be recorded
- Changes from baseline in total protein of Laboratory Examination. [Within Day 169 of after receiving Lipovirtide administration]
Changes of total protein concentration (g/L) in serum will be recorded.
- Changes from baseline in albumin of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of albumin concentration (g/L) in serum will be recorded
- Changes from baseline in creatinine of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of creatinine concentration (μmol/L) in serum will be recorded
- Changes from baseline in glucose of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of glucose concentration (mmol/L) in serum will be recorded.
- Changes from baseline in potassium of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of potassium concentration (mmol/L) in serum will be recorded
- Changes from baseline in sodium of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of sodium concentration (mmol/L) in serum will be recorded
- Changes from baseline in chlorine of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of chlorine concentration (mmol/L) in serum will be recorded
- Changes from baseline in urine specific gravity of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of urine specific gravity will be recorded.
- Changes from baseline in urine pH of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of urine pH value will be recorded
- Changes from baseline in urine glucose of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of urine glucose will be examined by qualitative test (positive or negative
- Changes from baseline in urine protein of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of urine protein will be examined by qualitative test (positive or negative
- Changes from baseline in urine ketone body of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of urine ketone body will be examined by qualitative test (positive or negative).
- Changes from baseline in urine white blood cell of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of white blood cell in urine will be examined by qualitative test (positive or negative).
- Changes from baseline in urine occult blood of Laboratory Examination. [Within Day 169 of after receiving Lipovirtide administration]
Changes of urine occult blood will be examined by qualitative test (positive or negative)
- Changes from baseline in LDH of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of LDH concentration (U/L) in serum will be recorded.
- Changes from baseline in Triglyceride of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of Triglyceride concentration (mmol/L) in serum will be recorded
- Changes from baseline in ALP of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of ALP concentration (U/L) in serum will be recorded
- Changes from baseline in CHOL of Laboratory Examination [Within Day 169 of after receiving Lipovirtide administration]
Changes of CHOL concentration (mmol/L) in serum will be recorded
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shanxi Kangbao Biological Product Co., Ltd.
- Institute of Pathogen Biology, Chinese Academy of Medical Sciences
Investigators
- Study Director: Ping Ma, Doctor, Tianjin Second People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SXKB-LP-80-201