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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: HIV
• Intervention / Treatment: Drug: Lipovirtide 10mg; Drug: Lipovirtide 40mg; Drug: Lipovirtide 60mg; Drug: DTG

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 Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ping Ma, Doctor; Phone Number: +8615922124490; Email: mapingtianjin@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Recruiting
      • Tianjin Second People's Hospital
      • Contact: Ping Ma, Doctor; Phone Number: +8615922124490; Email: mapingtianjin@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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: TDF; 3TC
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: TDF; 3TC
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: TDF; 3TC
Experimental: Group D：DTG +3TC + TDF; DTG +3TC + TDF（once daily）	Drug: DTG; DTG +3TC + TDF（once daily）.; Other Names: TDF; 3TC

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanxi Kangbao Biological Product Co., Ltd.
• Collaborators: Institute of Pathogen Biology, Chinese Academy of Medical Sciences
• Investigators: Study Director: Ping Ma, Doctor, Tianjin Second People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2023
• Primary Completion (Estimated): June 20, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 23, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: HIV; Lipovirtide; nucleoside drugs
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Lamivudine
• Other Study ID Numbers: SXKB-LP-80-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No