Overview
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients Without Prior Antiviral Therapy
Status:
Recruiting
Recruiting
Trial end date:
2021-10-12
2021-10-12
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Shanxi Kangbao Biological Product Co., Ltd.Collaborator:
Chinese Academy of Medical Sciences
Criteria
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.