Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-25 @ 3:09 PM
Study NCT ID:
NCT05349968
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2022-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Efficacy of Multiple Dosing of Lipovirtide for Injection in HIV-infected Patients
Sponsor:
Shanxi Kangbao Biological Product Co., Ltd.
Organization:
Study Overview
Official Title:
A Clinical Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Multiple Dosing of Lipovirtide for Injection in HIV-infected Patients Who Have Not Received Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objectives
1.Evaluation of safety and tolerability after repeated administration of injectable Lipivirtide in HIV-infected patients not receiving antiretroviral therapy
Secondary Objectives
1. Evaluation of the pharmacokinetic properties of injectable Lipovirtide after multiple administrations in HIV-infected patients not receiving antiretroviral therapy, to obtain pharmacokinetic parameters.
2. Evaluation of the efficacy of injectable Lipovirtide for HIV in HIV-infected patients not receiving antiretroviral therapy.
3. Evaluation of the immunogenicity of lipovirtide for injection.
1.Evaluation of safety and tolerability after repeated administration of injectable Lipivirtide in HIV-infected patients not receiving antiretroviral therapy
Secondary Objectives
1. Evaluation of the pharmacokinetic properties of injectable Lipovirtide after multiple administrations in HIV-infected patients not receiving antiretroviral therapy, to obtain pharmacokinetic parameters.
2. Evaluation of the efficacy of injectable Lipovirtide for HIV in HIV-infected patients not receiving antiretroviral therapy.
3. Evaluation of the immunogenicity of lipovirtide for injection.
Detailed Description:
PK parameters were calculated by Phoenix WinNonlin 8.2 (or higher) and other data were analyzed using SAS 9.4 (or higher) software.
Full analysis set: will be used for efficacy analysis. Descriptive statistics of HIV viral load and CD4+ T-cell count at each time point, calculation of subject means, standard deviations, quartiles, minimum and maximum values, and comparison of changes from baseline at each time point.
Safety analysis set: calculation of the incidence of adverse events and systematic categorization. Calculate the incidence of adverse events and systematically categorize them. Cross tabulation of clinical determination before and after drug administration for laboratory tests, ECG tests, and physical examination. Changes in measured values of vital signs over time. The actual measured values of the vital signs varied over time.
Immunogenicity analysis: statistics of the results of each indicators (including the positive incidence and titer) over time, and a detailed list of the results of each visit.
Pharmacokinetic analysis: individual and mean c-t curves were plotted; mean, standard deviation, interquartile, maximum, minimum and coefficient of variation of blood concentrations at each time point were listed. Pharmacokinetic parameters were calculated for each subject from the non-compartment model. and the arithmetic mean, standard deviation, quartiles, maximum value, minimum value and geometric mean and coefficient of variation were also calculated for each parameter.
Full analysis set: will be used for efficacy analysis. Descriptive statistics of HIV viral load and CD4+ T-cell count at each time point, calculation of subject means, standard deviations, quartiles, minimum and maximum values, and comparison of changes from baseline at each time point.
Safety analysis set: calculation of the incidence of adverse events and systematic categorization. Calculate the incidence of adverse events and systematically categorize them. Cross tabulation of clinical determination before and after drug administration for laboratory tests, ECG tests, and physical examination. Changes in measured values of vital signs over time. The actual measured values of the vital signs varied over time.
Immunogenicity analysis: statistics of the results of each indicators (including the positive incidence and titer) over time, and a detailed list of the results of each visit.
Pharmacokinetic analysis: individual and mean c-t curves were plotted; mean, standard deviation, interquartile, maximum, minimum and coefficient of variation of blood concentrations at each time point were listed. Pharmacokinetic parameters were calculated for each subject from the non-compartment model. and the arithmetic mean, standard deviation, quartiles, maximum value, minimum value and geometric mean and coefficient of variation were also calculated for each parameter.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: