Clinical trial NCT06061536: Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients.
Official 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: HIV
Keywords: Lipovirtide
HIV
nucleoside drugs
Lead sponsor: Shanxi Kangbao Biological Product Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chinese Academy of Medical Sciences
First posted: 2023-09-29
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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）.

Eligibility criteria: 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.

Primary outcomes:
measure: HIV-1 RNA <50 copies/ml
timeFrame: at Day 169 after receiving Lipovirtide administration.
Secondary outcomes:
measure: HIV-1 RNA <50 copies/ml
timeFrame: at Day 29、Day 85、Day 169 after receiving Lipovirtide administration
measure: HIV-1 RNA <400 copies/ml
timeFrame: at Day 85、Day 169 after receiving Lipovirtide administration
measure: CD4+ T-cell and CD8+ T-cell
timeFrame: at Day 85 and Day 169 after receiving Lipovirtide administration
measure: HIV-1 RNA <50 copies/ml
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: HIV-1 RNA
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in respiration rate of Vital Signs
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in blood pressure of Vital Signs
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in body temperature of Vital Signs
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in ECG PR intervalThe cardiac rhythm is showed in 12 Leads
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in ECG QRS intervalThe cardiac rhythm is showed in 12 Leads
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in ECG QT intervalThe cardiac rhythm is showed in 12 Leads
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in Blood lactate of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in Pregnancy test of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in red blood cell count of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in white blood cell count of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in neutrophil count of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in lymphocyte count of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in platelet count of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in hemoglobin of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in PT of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in INR of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in APTT of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in direct bilirubin of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in ALT of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in AST of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in total protein of Laboratory Examination.
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in albumin of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in creatinine of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in glucose of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in potassium of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in sodium of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in chlorine of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in urine specific gravity of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in urine pH of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in urine glucose of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in urine protein of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in urine ketone body of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in urine white blood cell of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in urine occult blood of Laboratory Examination.
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in LDH of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in Triglyceride of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in ALP of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
measure: Changes from baseline in CHOL of Laboratory Examination
timeFrame: Within Day 169 of after receiving Lipovirtide administration
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Second People's Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Second People's Hospital
name: Ping Ma, Doctor
role: STUDY_DIRECTOR
References: