A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Lipovirtide Injection
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility Criteria
Inclusion Criteria:
- Male or female aged from 18 to 60 (include 18 and 60);
- Body mass index (BMI) [weight (kg)/ height 2(m2)] is from 18.0 to 26.0(include 18.0 and 26.0),male weight≥50kg,female weight≥45kg;
- Confirmed HIV-1 infection;
- HIV viral load ≥ 1000 copies/mL;
- Patients who have no birth plan within 2 weeks before the screening and 3 months after the end of the trial, consenting to take effective non-drug contraceptive measures during the trial period;
- Understand the purpose of and procedures required for the study and having confirmed they are willing to participate in the study by signing the informed consent document.
Exclusion Criteria:
- Patients in the acute infection stage;
- Confirmed AIDS patients;
- Patients who have received antiviral therapy and/or have been vaccinated against HIV;
- HBsAg is (+), and/or anti-HCV is (+);
- Abnormal liver function tests (ALT and / or AST> 3ULN, or total bilirubin> 2ULN);
- Glomerular filtration rate <70mL/min/1.73m2, or creatinine ≥ULN;
- Patients who is currently suffering from a more serious chronic diseases, metabolic diseases (such as diabetes), neurological and mental diseases;
- Patients who have previous history of pancreatitis;
- Females who are pregnant or breastfeeding, or females of childbearing age who are unable to take contraception as required;
- Allergic constitution or known allergy to the components of study drug;
- With a history of smoking addiction within 12 months before screening (average number≥5 cigarettes per day);
- With a history of alcohol abuse within 12 months before screening (average drinking≥14 units of alcohol per week: 1 unit = 285mL beer, 25mL spirits, or 150mL wine) or those who have a positive alcohol breath test before enrollment;
- With a history of drug abuse within 12 months before screening or those who tested positive for addictive substances before enrollment;
- Patients who have participated in other investigational drug study within 3 months before screening (except for traditional Chinese medicine);
- Other factors that the investigators consider unsuitable for the trial.
Sites / Locations
- Beijing You'an Hospital, Beijing Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
6
Arm Description
Dose 5 mg
Dose 10 mg
Dose 20 mg
Dose 40 mg
Dose 60 mg
Dose 80 mg
Outcomes
Primary Outcome Measures
Pharmacokinetics:Cmax
pharmacokinetic characteristics of Lipovirtide in infected patients:Cmax
Pharmacokinetics:AUC0-t
pharmacokinetic characteristics of Lipovirtide in infected patients:AUC0-t
Secondary Outcome Measures
Full Information
NCT ID
NCT04592315
First Posted
September 30, 2020
Last Updated
September 15, 2023
Sponsor
Shanxi Kangbao Biological Product Co., Ltd.
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04592315
Brief Title
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients
Official Title
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients Without Prior Antiviral Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 23, 2021 (Actual)
Primary Completion Date
May 2, 2023 (Actual)
Study Completion Date
July 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanxi Kangbao Biological Product Co., Ltd.
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the safety, tolerability of single dose lipovirtide injection in HIV-infected individuals without prior antiviral treatment, and to investigate the pharmacokinetic characteristics of infected patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Dose 5 mg
Arm Title
2
Arm Type
Experimental
Arm Description
Dose 10 mg
Arm Title
3
Arm Type
Experimental
Arm Description
Dose 20 mg
Arm Title
4
Arm Type
Experimental
Arm Description
Dose 40 mg
Arm Title
5
Arm Type
Experimental
Arm Description
Dose 60 mg
Arm Title
6
Arm Type
Experimental
Arm Description
Dose 80 mg
Intervention Type
Drug
Intervention Name(s)
Lipovirtide Injection
Intervention Description
Single dosage of Lipovirtide Injection
Primary Outcome Measure Information:
Title
Pharmacokinetics:Cmax
Description
pharmacokinetic characteristics of Lipovirtide in infected patients:Cmax
Time Frame
Day 0 to Day 7
Title
Pharmacokinetics:AUC0-t
Description
pharmacokinetic characteristics of Lipovirtide in infected patients:AUC0-t
Time Frame
Day 0 to Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female aged from 18 to 60 (include 18 and 60);
Body mass index (BMI) [weight (kg)/ height 2(m2)] is from 18.0 to 26.0(include 18.0 and 26.0),male weight≥50kg,female weight≥45kg;
Confirmed HIV-1 infection;
HIV viral load ≥ 1000 copies/mL;
Patients who have no birth plan within 2 weeks before the screening and 3 months after the end of the trial, consenting to take effective non-drug contraceptive measures during the trial period;
Understand the purpose of and procedures required for the study and having confirmed they are willing to participate in the study by signing the informed consent document.
Exclusion Criteria:
Patients in the acute infection stage;
Confirmed AIDS patients;
Patients who have received antiviral therapy and/or have been vaccinated against HIV;
HBsAg is (+), and/or anti-HCV is (+);
Abnormal liver function tests (ALT and / or AST> 3ULN, or total bilirubin> 2ULN);
Glomerular filtration rate <70mL/min/1.73m2, or creatinine ≥ULN;
Patients who is currently suffering from a more serious chronic diseases, metabolic diseases (such as diabetes), neurological and mental diseases;
Patients who have previous history of pancreatitis;
Females who are pregnant or breastfeeding, or females of childbearing age who are unable to take contraception as required;
Allergic constitution or known allergy to the components of study drug;
With a history of smoking addiction within 12 months before screening (average number≥5 cigarettes per day);
With a history of alcohol abuse within 12 months before screening (average drinking≥14 units of alcohol per week: 1 unit = 285mL beer, 25mL spirits, or 150mL wine) or those who have a positive alcohol breath test before enrollment;
With a history of drug abuse within 12 months before screening or those who tested positive for addictive substances before enrollment;
Patients who have participated in other investigational drug study within 3 months before screening (except for traditional Chinese medicine);
Other factors that the investigators consider unsuitable for the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haibin Yu, MD
Organizational Affiliation
Beijing You'an Hospital, Beijing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hao Wu, MD
Organizational Affiliation
Beijing You'an Hospital, Beijing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing You'an Hospital, Beijing Medical University
City
Beijing
State/Province
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients
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