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

Shanxi Kangbao Biological Product Co., Ltd.1 site in 1 country24 target enrollmentJune 10, 2022

ConditionsHIV Infections

InterventionsLipovirtide for injection

DrugsLipovirtide for injection

Overview

Phase: Phase 1
Intervention: Lipovirtide for injection
Conditions: HIV Infections
Sponsor: Shanxi Kangbao Biological Product Co., Ltd.
Enrollment: 24
Locations: 1
Primary Endpoint: Changes from baseline in Blood lactate of Laboratory Examination.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Evaluation of the pharmacokinetic properties of injectable Lipovirtide after multiple administrations in HIV-infected patients not receiving antiretroviral therapy, to obtain pharmacokinetic parameters.
Evaluation of the efficacy of injectable Lipovirtide for HIV in HIV-infected patients not receiving antiretroviral therapy.
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.

Registry

clinicaltrials.gov

Start Date

June 10, 2022

End Date

September 7, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Shanxi Kangbao Biological Product Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18\~60 years old (including the critical value), male and female are not limited.
•Body mass index BMI \[weight (kg)/height2 (m2)\] is 18.0\~28.0 (including the critical value), male weight should be ≥50kg, female weight should be ≥45kg.
•Diagnosed with HIV-1 infection.
•Those who did not plan to have children within 2 weeks prior to screening and within 3 months after the end of the trial and who agreed to use effective non-pharmacological contraception during the trial.
•Subjects should fully understand the purpose, nature and methods of the test and the possible adverse effects and voluntarily participate in this test.

Exclusion Criteria

•Subjects meeting any of the following criteria will not be allowed to enter the trial
•The presence of any of the following 1）Unexplained persistent irregular fever of 38°C or more for \>1 month. 2）Diarrhea (stools more than 3 times/day), \>1 month. 3）Weight loss of 10% or more within 6 months. 4）Recurrent oral fungal infections. 5）Recurrent herpes simplex virus infection or herpes zoster virus infection. 6）Pneumocystis carinii pneumonia (PCP). 7）Recurrent bacterial pneumonia. 8）Active tuberculosis or non-tuberculous mycobacteriosis. 9）Deep fungal infection. 10）Occupational lesions of the central nervous system. 11）Dementia in young and middle-aged adults. 12）Active cytomegalovirus (CMV) infection. 13）Toxoplasma encephalopathy. 14）Malnefield basket disease. 15）Recurrent sepsis. 16）Kaposi's sarcoma, lymphoma.
•Patients who have received antiviral therapy and/or HIV vaccination;
•HBsAg of (+), and/or anti-HCV of (+);
•Abnormal liver function (ALT/AST\>3XULN, or TBIL\>2XULN);
•Creatinine clearance\<70mL/min (Equation of calculation: Cockcroft-Gault)
•Existing severe chronic disease, metabolic disease (such as diabetes), neurological and psychiatric disease;
•History of pancreatitis;
•Regnant, lactating women and women of childbearing age who cannot use contraception as required;
•People with allergies or known allergies to the ingredients of this medicine;

Arms & Interventions

Dose 5 mg

Injected subcutaneously at room temperature into the abdomen (moles, scar tissue, bruises or areas other than the navel) and administered once a week for 4 weeks, with no more than 2.0 mL volume administered to a single site.

Intervention: Lipovirtide for injection

Dose 20 mg

Intervention: Lipovirtide for injection

Dose 40 mg

Intervention: Lipovirtide for injection