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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Single dosage of Lipovirtide Injection
Beijing You'an Hospital, Beijing Medical University
Beijing, Beijing Municipality, China
Number of Participants with Treatment-Related Adverse Events as Assessed by DAIDS v1.0
Evaluation of safety and tolerability after single dose of injectable Lipivirtide in HIV-infected patients not receiving antiretroviral therapy
Time frame: Day 1 to Day 15
Pharmacokinetic characteristics- Area Under the Plasma Concentration Versus Time Curve (AUC)
Evaluation of the pharmacokinetic properties of injectable Lipovirtide after single dose in HIV-infected patients not receiving antiretroviral therapy, to obtain pharmacokinetic parameters.
Time frame: 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."
Pharmacokinetic characteristics-Peak plasma concentration (Cmax)
Evaluation of the pharmacokinetic properties of injectable Lipovirtide after single dose in HIV-infected patients not receiving antiretroviral therapy, to obtain pharmacokinetic parameters.
Time frame: 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."
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