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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

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Arm Label

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

Studies a U.S. FDA-regulated Device Product

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

Arm Type

Experimental

Arm Description

Dose 5 mg

Arm Title

Arm Type

Experimental

Arm Description

Dose 10 mg

Arm Title

Arm Type

Experimental

Arm Description

Dose 20 mg

Arm Title

Arm Type

Experimental

Arm Description

Dose 40 mg

Arm Title

Arm Type

Experimental

Arm Description

Dose 60 mg

Arm Title

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

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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