A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients

HIV Infections Clinical Trial

Official title:

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients Without Prior Antiviral Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04592315
• Other study ID #: KB-LP-80-101
• Status: Completed
• Phase: Phase 1
• Start date: January 23, 2021
• Est. completion date: July 11, 2023

Study information

• Verified date: June 2023
• Source: Shanxi Kangbao Biological Product Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 11, 2023
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Male or female aged from 18 to 60 (include 18 and 60);

2. 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;

3. Confirmed HIV-1 infection;

4. HIV viral load = 1000 copies/mL;

5. 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;

6. 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:

1. Patients in the acute infection stage;

2. Confirmed AIDS patients;

3. Patients who have received antiviral therapy and/or have been vaccinated against HIV;

4. HBsAg is (+), and/or anti-HCV is (+);

5. Abnormal liver function tests (ALT and / or AST> 3ULN, or total bilirubin> 2ULN);

6. Glomerular filtration rate <70mL/min/1.73m2, or creatinine =ULN;

7. Patients who is currently suffering from a more serious chronic diseases, metabolic diseases (such as diabetes), neurological and mental diseases;

8. Patients who have previous history of pancreatitis;

9. Females who are pregnant or breastfeeding, or females of childbearing age who are unable to take contraception as required;

10. Allergic constitution or known allergy to the components of study drug;

11. With a history of smoking addiction within 12 months before screening (average number=5 cigarettes per day);

12. 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;

13. With a history of drug abuse within 12 months before screening or those who tested positive for addictive substances before enrollment;

14. Patients who have participated in other investigational drug study within 3 months before screening (except for traditional Chinese medicine);

15. Other factors that the investigators consider unsuitable for the trial.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Lipovirtide Injection
Single dosage of Lipovirtide Injection

Locations

Country	Name	City	State
China	Beijing You'an Hospital, Beijing Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Shanxi Kangbao Biological Product Co., Ltd.	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics:Cmax	pharmacokinetic characteristics of Lipovirtide in infected patients:Cmax	Day 0 to Day 7
Primary	Pharmacokinetics:AUC0-t	pharmacokinetic characteristics of Lipovirtide in infected patients:AUC0-t	Day 0 to Day 7