HIV Infections
Conditions
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.
Interventions
DRUGLipovirtide Injection
Single dosage of Lipovirtide Injection
Sponsors
Shanxi Kangbao Biological Product Co., Ltd.
Institute of Pathogen Biology, Beijing, China
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-Related Adverse Events as Assessed by DAIDS v1.0 | Day 1 to Day 15 | Evaluation of safety and tolerability after single dose of injectable Lipivirtide in HIV-infected patients not receiving antiretroviral therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic characteristics- Area Under the Plasma Concentration Versus Time Curve (AUC) | Area Under the Plasma Concentration Versus Time Curve (AUC) of Lipovirtide could have a time frame of "0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 30, 36h, 4, 72, 96, 120, 168 hours post-dose." | Evaluation of the pharmacokinetic properties of injectable Lipovirtide after single dose in HIV-infected patients not receiving antiretroviral therapy, to obtain pharmacokinetic parameters. |
| Pharmacokinetic characteristics-Peak plasma concentration (Cmax) | Peak plasma concentration (Cmax) of Lipovirtide could have a time frame of "0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 30, 36h, 4, 72, 96, 120, 168 hours post-dose." | Evaluation of the pharmacokinetic properties of injectable Lipovirtide after single dose in HIV-infected patients not receiving antiretroviral therapy, to obtain pharmacokinetic parameters. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHaibin Yu, MD
Beijing You'an Hospital, Beijing Medical University
PRINCIPAL_INVESTIGATORHao Wu, MD
Beijing You'an Hospital, Beijing Medical University
Outcome results
None listed