HIV InfectionsPhase 1NCT05349968

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

A Phase 1 study testing Lipovirtide for injection in people with HIV Infections, run by Shanxi Kangbao Biological Product Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: HIV Infections
What is being tested?: Lipovirtide for injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 10 Jun 2022to 7 Sep 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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)

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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;
People with a history of smoking within 12 months before screening (the average number of cigarettes smoked per day is 35.);
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;
People with have a history of drug abuse within 12 months before screening or those who tested positive for addictive substances before enrollment;
Participated in other drug trials within 3 months before screening;
The investigator believes that the subject has other conditions that are not suitable for participating in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing You'an Hospital, Beijing Medical University
Beijing

Other trials in China

About this study

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

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.

Read the 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.

Conditions: HIV Infections
Being tested: Lipovirtide for injection
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lipovirtide for injectionDrug
Also called nothing
Multiple dosing of Lipovirtide

Study groups in NCT05349968
Study group	Role	What they receive
Dose 5 mg	Experimental	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. Receives: Drug: Lipovirtide for injection
Dose 20 mg	Experimental	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. Receives: Drug: Lipovirtide for injection
Dose 40 mg	Experimental	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. Receives: Drug: Lipovirtide for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes from baseline in respiration rate of Vital Signs.
Respiration rate in times / minute
Measured: Within 50 days after the first administration.
Changes from baseline in Blood lactate of Laboratory Examination.
Changes of blood lactate will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in Pregnancy test of Laboratory Examination.
Pregnancy test will be tested in female subjects.
Measured: Within 50 days after the first administration.
Changes from baseline in Drug resistance test of Laboratory Examination.
Changes of drug resistance test will be recorded.Evaluate the proportion of HIV resistance in subjects.
Measured: Within 50 days after the first administration.
Changes from baseline in Immunogenic blood collection of Laboratory Examination.
Changes of immunogenic blood collection will be recorded.The historical changes of test results (including positive rate and titer) of various indicators were counted.
Measured: Within 50 days after the first administration.
Changes from baseline in blood pressure of Vital Signs.
Blood pressure in mmHg
Measured: Within 50 days after the first administration.
Changes from baseline in body temperature of Vital Signs.
Body temperature in Celsius degree
Measured: Within 50 days after the first administration.
Changes from baseline in red blood cell count of Laboratory Examination.
Red blood cell count in whole blood is reported in the form of number.
Measured: Within 50 days after the first administration.
Changes from baseline in white blood cell count of Laboratory Examination.
White blood cell count in whole blood is reported in the form of number.
Measured: Within 50 days after the first administration.
Changes from baseline in neutrophil count of Laboratory Examination.
Neutrophil count in whole blood is reported in the form of number.
Measured: Within 50 days after the first administration.
Changes from baseline in lymphocyte count of Laboratory Examination.
Lymphocyte count in whole blood is reported in the form of number.
Measured: Within 50 days after the first administration.
Changes from baseline in platelet count of Laboratory Examination.
Platelet count in whole blood is reported in the form of number.
Measured: Within 50 days after the first administration.
Changes from baseline in hemoglobin of Laboratory Examination.
Changes of hemoglobin concentration（g/dL）in whole blood will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in PT of Laboratory Examination.
Prothrombin time (PT) is a screening test for exogenous coagulation factors.
Measured: Within 50 days after the first administration.
Changes from baseline in INR of Laboratory Examination.
International standardized ratio (INR) is calculated from prothrombin time and international sensitivity index (ISI) of the reagent.
Measured: Within 50 days after the first administration.
Changes from baseline in APTT of Laboratory Examination.
Activated partial thromboplastin time (APTT) is a screening test for endogenous coagulation factors.
Measured: Within 50 days after the first administration.
Changes from baseline in total bilirubin of Laboratory Examination.
Changes of total bilirubin concentration (μmol/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in direct bilirubin of Laboratory Examination.
Changes of direct bilirubin concentration (μmol/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in ALT of Laboratory Examination.
Changes of ALT concentration (U/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in AST of Laboratory Examination.
Changes of AST concentration (U/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in total protein of Laboratory Examination.
Changes of total protein concentration (g/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in albumin of Laboratory Examination.
Changes of albumin concentration (g/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in total bile acid of Laboratory Examination
Changes of total bile acid concentration (μmol/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in urea of Laboratory Examination.
Changes of urea concentration (mmol/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in creatinine of Laboratory Examination.
Changes of creatinine concentration (μmol/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in uric acid of Laboratory Examination.
Changes of uric acid concentration (μmol/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in glucose of Laboratory Examination
Changes of glucose concentration (mmol/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in potassium of Laboratory Examination.
Changes of potassium concentration (mmol/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in sodium of Laboratory Examination.
Changes of sodium concentration (mmol/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in chlorine of Laboratory Examination.
Changes of chlorine concentration (mmol/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in urine specific gravity of Laboratory Examination.
Changes of urine specific gravity will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in urine pH of Laboratory Examination.
Changes of urine pH value will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in urine glucose of Laboratory Examination.
Changes of urine glucose will be examined by qualitative test (positive or negative).
Measured: Within 50 days after the first administration.
Changes from baseline in urine protein of Laboratory Examination.
Changes of urine protein will be examined by qualitative test (positive or negative).
Measured: Within 50 days after the first administration.
Changes from baseline in urine ketone body of Laboratory Examination.
Changes of urine ketone body will be examined by qualitative test (positive or negative).
Measured: Within 50 days after the first administration.
Changes from baseline in urine white blood cell of Laboratory Examination.
Changes of white blood cell in urine will be examined by qualitative test (positive or negative).
Measured: Within 50 days after the first administration.
Changes from baseline in urine bilirubin of Laboratory Examination.
Changes of urine bilirubin will be examined by qualitative test (positive or negative).
Measured: Within 50 days after the first administration.
Changes from baseline in urine occult blood of Laboratory Examination.
Changes of urine occult blood will be examined by qualitative test (positive or negative).
Measured: Within 50 days after the first administration.
Changes from baseline in Electrocardiogram.
The cardiac rhythm is showed in electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded，To evaluate the incidence of abnormal electrocardiogram.
Measured: Within 50 days after the first administration.
Changes from baseline in CK of Laboratory Examination
Changes of CK concentration (U/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in CK-MB of Laboratory Examination
Changes of CK-MB concentration (ng/mL) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in LDH of Laboratory Examination
Changes of LDH concentration (U/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in ALP of Laboratory Examination
Changes of ALP concentration (U/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in Triglyceride of Laboratory Examination
Changes of Triglyceride concentration (mmol/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in CHOL of Laboratory Examination
Changes of CHOL concentration (mmol/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in TP of Laboratory Examination
Changes of TP concentration (g/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in ALB of Laboratory Examination
Changes of ALB concentration (g/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in UA of Laboratory Examination
Changes of UA concentration (μmol/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in GLU of Laboratory Examination
Changes of GLU concentration (mmol/L) in serum will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in AMY of Laboratory Examination
Changes of AMY concentration (U/L) in serum will be recorded.
Measured: Within 50 days after the first administration.

Secondary outcomes (3)

Changes from baseline in HIV viral load detection of Laboratory Examination.
Changes of HIV viral load detection will be recorded.
Measured: Within 50 days after the first administration.
Changes from baseline in CD4+T cell counts of Laboratory Examination.
Changes of CD4+T cell counts will be recorded.
Measured: Within 50 days after the first administration.
Incidence of anti-Lipovetin antibody.
Incidence of anti-Lipovetin antibody.
Measured: Within 50 days after the first administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 20227 Sep 2023

First posted27 Apr 2022
Study start10 Jun 2022
Primary completion7 Jun 2023
Study completion7 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05349968
Sponsor's protocol ID: KB-LP-80-102
Status last verified: Apr 2022
First submitted: 2 Apr 2022
Last updated: 11 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05349968
Acronym / sponsor ID: KB-LP-80-102
Conditions: HIV Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Shanxi Kangbao Biological Product Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Institute of Pathogen Biology, Beijing, China
Study start: 10 Jun 2022 (actual)
Primary completion: 7 Jun 2023 (actual)
Study completion: 7 Sep 2023 (actual)
First posted: 27 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Dose 5 mg	Experimental	Drug: Lipovirtide for injectionInjected 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.
Dose 20 mg	Experimental	Drug: Lipovirtide for injectionInjected 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.
Dose 40 mg	Experimental	Drug: Lipovirtide for injectionInjected 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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (15 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lipovirtide for injectionAlso: nothingMultiple dosing of Lipovirtide	Drug	Dose 20 mg, Dose 40 mg, Dose 5 mg

Primary outcome

Changes from baseline in respiration rate of Vital Signs.
Time frame: Within 50 days after the first administration.
Respiration rate in times / minute
Changes from baseline in Blood lactate of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of blood lactate will be recorded.
Changes from baseline in Pregnancy test of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Pregnancy test will be tested in female subjects.
Changes from baseline in Drug resistance test of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of drug resistance test will be recorded.Evaluate the proportion of HIV resistance in subjects.
Changes from baseline in Immunogenic blood collection of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of immunogenic blood collection will be recorded.The historical changes of test results (including positive rate and titer) of various indicators were counted.
Changes from baseline in blood pressure of Vital Signs.
Time frame: Within 50 days after the first administration.
Blood pressure in mmHg
Changes from baseline in body temperature of Vital Signs.
Time frame: Within 50 days after the first administration.
Body temperature in Celsius degree
Changes from baseline in red blood cell count of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Red blood cell count in whole blood is reported in the form of number.
Changes from baseline in white blood cell count of Laboratory Examination.
Time frame: Within 50 days after the first administration.
White blood cell count in whole blood is reported in the form of number.
Changes from baseline in neutrophil count of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Neutrophil count in whole blood is reported in the form of number.
Changes from baseline in lymphocyte count of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Lymphocyte count in whole blood is reported in the form of number.
Changes from baseline in platelet count of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Platelet count in whole blood is reported in the form of number.
Changes from baseline in hemoglobin of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of hemoglobin concentration（g/dL）in whole blood will be recorded.
Changes from baseline in PT of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Prothrombin time (PT) is a screening test for exogenous coagulation factors.
Changes from baseline in INR of Laboratory Examination.
Time frame: Within 50 days after the first administration.
International standardized ratio (INR) is calculated from prothrombin time and international sensitivity index (ISI) of the reagent.
Changes from baseline in APTT of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Activated partial thromboplastin time (APTT) is a screening test for endogenous coagulation factors.
Changes from baseline in total bilirubin of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of total bilirubin concentration (μmol/L) in serum will be recorded.
Changes from baseline in direct bilirubin of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of direct bilirubin concentration (μmol/L) in serum will be recorded.
Changes from baseline in ALT of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of ALT concentration (U/L) in serum will be recorded.
Changes from baseline in AST of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of AST concentration (U/L) in serum will be recorded.
Changes from baseline in total protein of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of total protein concentration (g/L) in serum will be recorded.
Changes from baseline in albumin of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of albumin concentration (g/L) in serum will be recorded.
Changes from baseline in total bile acid of Laboratory Examination
Time frame: Within 50 days after the first administration.
Changes of total bile acid concentration (μmol/L) in serum will be recorded.
Changes from baseline in urea of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of urea concentration (mmol/L) in serum will be recorded.
Changes from baseline in creatinine of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of creatinine concentration (μmol/L) in serum will be recorded.
Changes from baseline in uric acid of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of uric acid concentration (μmol/L) in serum will be recorded.
Changes from baseline in glucose of Laboratory Examination
Time frame: Within 50 days after the first administration.
Changes of glucose concentration (mmol/L) in serum will be recorded.
Changes from baseline in potassium of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of potassium concentration (mmol/L) in serum will be recorded.
Changes from baseline in sodium of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of sodium concentration (mmol/L) in serum will be recorded.
Changes from baseline in chlorine of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of chlorine concentration (mmol/L) in serum will be recorded.
Changes from baseline in urine specific gravity of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of urine specific gravity will be recorded.
Changes from baseline in urine pH of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of urine pH value will be recorded.
Changes from baseline in urine glucose of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of urine glucose will be examined by qualitative test (positive or negative).
Changes from baseline in urine protein of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of urine protein will be examined by qualitative test (positive or negative).
Changes from baseline in urine ketone body of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of urine ketone body will be examined by qualitative test (positive or negative).
Changes from baseline in urine white blood cell of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of white blood cell in urine will be examined by qualitative test (positive or negative).
Changes from baseline in urine bilirubin of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of urine bilirubin will be examined by qualitative test (positive or negative).
Changes from baseline in urine occult blood of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes of urine occult blood will be examined by qualitative test (positive or negative).
Changes from baseline in Electrocardiogram.
Time frame: Within 50 days after the first administration.
The cardiac rhythm is showed in electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded，To evaluate the incidence of abnormal electrocardiogram.
Changes from baseline in CK of Laboratory Examination
Time frame: Within 50 days after the first administration.
Changes of CK concentration (U/L) in serum will be recorded.
Changes from baseline in CK-MB of Laboratory Examination
Time frame: Within 50 days after the first administration.
Changes of CK-MB concentration (ng/mL) in serum will be recorded.
Changes from baseline in LDH of Laboratory Examination
Time frame: Within 50 days after the first administration.
Changes of LDH concentration (U/L) in serum will be recorded.
Changes from baseline in ALP of Laboratory Examination
Time frame: Within 50 days after the first administration.
Changes of ALP concentration (U/L) in serum will be recorded.
Changes from baseline in Triglyceride of Laboratory Examination
Time frame: Within 50 days after the first administration.
Changes of Triglyceride concentration (mmol/L) in serum will be recorded.
Changes from baseline in CHOL of Laboratory Examination
Time frame: Within 50 days after the first administration.
Changes of CHOL concentration (mmol/L) in serum will be recorded.
Changes from baseline in TP of Laboratory Examination
Time frame: Within 50 days after the first administration.
Changes of TP concentration (g/L) in serum will be recorded.
Changes from baseline in ALB of Laboratory Examination
Time frame: Within 50 days after the first administration.
Changes of ALB concentration (g/L) in serum will be recorded.
Changes from baseline in UA of Laboratory Examination
Time frame: Within 50 days after the first administration.
Changes of UA concentration (μmol/L) in serum will be recorded.
Changes from baseline in GLU of Laboratory Examination
Time frame: Within 50 days after the first administration.
Changes of GLU concentration (mmol/L) in serum will be recorded.
Changes from baseline in AMY of Laboratory Examination
Time frame: Within 50 days after the first administration.
Changes of AMY concentration (U/L) in serum will be recorded.

3 secondary outcomes

Changes from baseline in HIV viral load detection of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Changes from baseline in CD4+T cell counts of Laboratory Examination.
Time frame: Within 50 days after the first administration.
Incidence of anti-Lipovetin antibody.
Time frame: Within 50 days after the first administration.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Haibin Yu principal investigator

Beijing You'an Hospital, Beijing Medical University

Hao Wu principal investigator

Beijing You'an Hospital, Beijing Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lipovirtide for injection in people with HIV Infections, run by Shanxi Kangbao Biological Product Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline in respiration rate of Vital Signs. (time frame: Within 50 days after the first administration.). The study lists 50 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05349968.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.