NCT06061536
Completed
Phase 2
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.
Shanxi Kangbao Biological Product Co., Ltd.1 site in 1 country64 target enrollmentNovember 2, 2023
ConditionsHIV
Overview
- Phase
- Phase 2
- Intervention
- Lipovirtide 40mg
- Conditions
- HIV
- Sponsor
- Shanxi Kangbao Biological Product Co., Ltd.
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- HIV-1 RNA <50 copies/ml
- Status
- Completed
- Last Updated
- 2 months ago
Overview
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.
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）.
Investigators
Eligibility 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;
Arms & Interventions
Group B：Lipovirtide 40mg+3TC+TDF
Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）
Intervention: Lipovirtide 40mg
Group A：Lipovirtide 10mg+3TC+TDF
Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）
Intervention: Lipovirtide 10mg
Group C：Lipovirtide 60mg+3TC+TDF
Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily）
Intervention: Lipovirtide 60mg
Group D：DTG +3TC + TDF
DTG +3TC + TDF（once daily）
Intervention: DTG
Outcomes
Primary Outcomes
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
- CD4+ T-cell and CD8+ T-cell(at Day 85 and Day 169 after receiving Lipovirtide administration)
- HIV-1 RNA(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in respiration rate of Vital Signs(Within Day 169 of after receiving Lipovirtide administration)
- HIV-1 RNA <50 copies/ml(Within Day 169 of after receiving Lipovirtide administration)
- HIV-1 RNA <400 copies/ml(at Day 85、Day 169 after receiving Lipovirtide administration)
- Changes from baseline in blood pressure of Vital Signs(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in ECG QT intervalThe cardiac rhythm is showed in 12 Leads(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in creatinine of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in red blood cell count of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in body temperature of Vital Signs(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in ECG PR intervalThe cardiac rhythm is showed in 12 Leads(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in ECG QRS intervalThe cardiac rhythm is showed in 12 Leads(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in Blood lactate of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in Pregnancy test of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in lymphocyte count of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in white blood cell count of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in neutrophil count of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in platelet count of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in hemoglobin of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in PT of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in INR of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in albumin of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in glucose of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in potassium of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in sodium of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in chlorine of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in urine specific gravity of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in APTT of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in direct bilirubin of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in ALT of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in AST of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in total protein of Laboratory Examination.(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in Triglyceride of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in urine pH of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in urine glucose of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in urine protein of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in urine ketone body of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in urine white blood cell of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in urine occult blood of Laboratory Examination.(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in LDH of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in ALP of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- Changes from baseline in CHOL of Laboratory Examination(Within Day 169 of after receiving Lipovirtide administration)
- HIV-1 RNA <50 copies/ml(at Day 29、Day 85、Day 169 after receiving Lipovirtide administration)
Study Sites (1)
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