Pharmacokinetics and Efficacy of Multiple Dosing of Lipovirtide for Injection in HIV-infected Patients

Shanxi Kangbao Biological Product

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Lipovirtide for injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05349968

KB-LP-80-102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18~60 years old (including the critical value), male and female are not limited.
2. 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.
3. Diagnosed with HIV-1 infection.
4. 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.
5. 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

1. 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.
2. Patients who have received antiviral therapy and/or HIV vaccination;
3. HBsAg of (+), and/or anti-HCV of (+);
4. Abnormal liver function (ALT/AST>3XULN, or TBIL>2XULN);
5. Creatinine clearance<70mL/min (Equation of calculation: Cockcroft-Gault)
6. Existing severe chronic disease, metabolic disease (such as diabetes), neurological and psychiatric disease;
7. History of pancreatitis;
8. Regnant, lactating women and women of childbearing age who cannot use contraception as required;
9. People with allergies or known allergies to the ingredients of this medicine;
10. People with a history of smoking within 12 months before screening (the average number of cigarettes smoked per day is 35.);
11. People with a history of alcoholism within 12 months before screening(Drink N14 units of alcohol per week on average: 1 unit = 285mL of beer, or 25mL of spirits, or 150mL of wine) or positive alcohol breath test before enrollment;
12. People with have a history of drug abuse within 12 months before screening or those who tested positive for addictive substances before enrollment;
13. Participated in other drug trials within 3 months before screening;
14. The investigator believes that the subject has other conditions that are not suitable for participating in the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Dose 5 mg

Experimental group

Description:

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.

Treatment:

Drug: Lipovirtide for injection

Dose 20 mg

Experimental group

Description:

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.

Treatment:

Drug: Lipovirtide for injection

Dose 40 mg

Experimental group

Description:

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.

Treatment:

Drug: Lipovirtide for injection