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Completed

NCT Number: NCT06061536

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, 300000, China

About this study

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）.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lipovirtide 10mg

Drug

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

Other names: 3TC, TDF

Lipovirtide 40mg

Drug

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

Other names: 3TC, TDF

Lipovirtide 60mg

Drug

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

Other names: 3TC, TDF

DTG

Drug

DTG +3TC + TDF（once daily）.

Other names: 3TC, TDF

Primary outcomes

  1. HIV-1 RNA <50 copies/ml

    Time frame: 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 outcomes

  1. HIV-1 RNA <50 copies/ml

    Time frame: 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

  2. HIV-1 RNA <400 copies/ml

    Time frame: 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

  3. CD4+ T-cell and CD8+ T-cell

    Time frame: 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

  4. HIV-1 RNA <50 copies/ml

    Time frame: Within Day 169 of after receiving Lipovirtide administration

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

  5. HIV-1 RNA

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    The temporal changes in log-transformed HIV-1 RNA levels compared to baseline

  6. Changes from baseline in respiration rate of Vital Signs

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Respiration rate in times / minute

  7. Changes from baseline in blood pressure of Vital Signs

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Blood pressure in mmHg

  8. Changes from baseline in body temperature of Vital Signs

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Body temperature in Celsius degree

  9. Changes from baseline in ECG PR intervalThe cardiac rhythm is showed in 12 Leads

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.

  10. Changes from baseline in ECG QRS intervalThe cardiac rhythm is showed in 12 Leads

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded

  11. Changes from baseline in ECG QT intervalThe cardiac rhythm is showed in 12 Leads

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded

  12. Changes from baseline in Blood lactate of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of blood lactate will be recorded

  13. Changes from baseline in Pregnancy test of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Pregnancy test will be tested in female subjects

  14. Changes from baseline in red blood cell count of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Red blood cell count in whole blood is reported in the form of number

  15. Changes from baseline in white blood cell count of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    White blood cell count in whole blood is reported in the form of number

  16. Changes from baseline in neutrophil count of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Neutrophil count in whole blood is reported in the form of number

  17. Changes from baseline in lymphocyte count of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Lymphocyte count in whole blood is reported in the form of number

  18. Changes from baseline in platelet count of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Platelet count in whole blood is reported in the form of number.

  19. Changes from baseline in hemoglobin of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of hemoglobin concentration（g/dL）in whole blood will be recorded.

  20. Changes from baseline in PT of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Prothrombin time (PT) is a screening test for exogenous coagulation factors

  21. Changes from baseline in INR of Laboratory Examination

    Time frame: 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

  22. Changes from baseline in APTT of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of total bilirubin concentration (μmol/L) in serum will be recorded

  23. Changes from baseline in direct bilirubin of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of direct bilirubin concentration (μmol/L) in serum will be recorded.

  24. Changes from baseline in ALT of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of ALT concentration (U/L) in serum will be recorded

  25. Changes from baseline in AST of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of AST concentration (U/L) in serum will be recorded

  26. Changes from baseline in total protein of Laboratory Examination.

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of total protein concentration (g/L) in serum will be recorded.

  27. Changes from baseline in albumin of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of albumin concentration (g/L) in serum will be recorded

  28. Changes from baseline in creatinine of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of creatinine concentration (μmol/L) in serum will be recorded

  29. Changes from baseline in glucose of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of glucose concentration (mmol/L) in serum will be recorded.

  30. Changes from baseline in potassium of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of potassium concentration (mmol/L) in serum will be recorded

  31. Changes from baseline in sodium of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of sodium concentration (mmol/L) in serum will be recorded

  32. Changes from baseline in chlorine of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of chlorine concentration (mmol/L) in serum will be recorded

  33. Changes from baseline in urine specific gravity of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of urine specific gravity will be recorded.

  34. Changes from baseline in urine pH of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of urine pH value will be recorded

  35. Changes from baseline in urine glucose of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of urine glucose will be examined by qualitative test (positive or negative

  36. Changes from baseline in urine protein of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of urine protein will be examined by qualitative test (positive or negative

  37. Changes from baseline in urine ketone body of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of urine ketone body will be examined by qualitative test (positive or negative).

  38. Changes from baseline in urine white blood cell of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of white blood cell in urine will be examined by qualitative test (positive or negative).

  39. Changes from baseline in urine occult blood of Laboratory Examination.

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of urine occult blood will be examined by qualitative test (positive or negative)

  40. Changes from baseline in LDH of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of LDH concentration (U/L) in serum will be recorded.

  41. Changes from baseline in Triglyceride of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of Triglyceride concentration (mmol/L) in serum will be recorded

  42. Changes from baseline in ALP of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of ALP concentration (U/L) in serum will be recorded

  43. Changes from baseline in CHOL of Laboratory Examination

    Time frame: Within Day 169 of after receiving Lipovirtide administration

    Changes of CHOL concentration (mmol/L) in serum will be recorded

Sponsors and collaborators

Lead sponsor

Shanxi Kangbao Biological Product Co., Ltd.

Industry

Collaborators

  • Institute of Pathogen Biology, Beijing, China

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 29, 2023
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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