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
Sponsor study identifier
interventional
24
1 country
1
Study Start
June 10, 2022
Actual (reported)Primary Completion
June 7, 2023
Actual (reported)Study Completion
September 7, 2023
Actual (reported)Primary Objectives 1.Evaluation of safety and tolerability after repeated administration of injectable Lipivirtide in HIV-infected patients not receiving antiretroviral therapy Secondary Objectives
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 7, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2, 2022
Actual (reported)April 27, 2022
Actual (reported)June 10, 2022
Actual (reported)June 7, 2023
Actual (reported)September 7, 2023
Actual (reported)Changes from baseline in respiration rate of Vital Signs.
Respiration rate in times / minute
Within 50 days after the first administration.
Changes from baseline in Blood lactate of Laboratory Examination.
Changes of blood lactate will be recorded.
Within 50 days after the first administration.
Changes from baseline in Pregnancy test of Laboratory Examination.
Pregnancy test will be tested in female subjects.
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.
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.
Within 50 days after the first administration.
Changes from baseline in blood pressure of Vital Signs.
Blood pressure in mmHg
Within 50 days after the first administration.
Changes from baseline in body temperature of Vital Signs.
Body temperature in Celsius degree
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Within 50 days after the first administration.
Changes from baseline in urine pH of Laboratory Examination.
Changes of urine pH value will be recorded.
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).
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Within 50 days after the first administration.
Changes from baseline in HIV viral load detection of Laboratory Examination.
Within 50 days after the first administration.
Changes from baseline in CD4+T cell counts of Laboratory Examination.
Within 50 days after the first administration.
Incidence of anti-Lipovetin antibody.
Within 50 days after the first administration.
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.
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.
Multiple dosing of Lipovirtide
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Beijing You'an Hospital, Beijing Medical University
Beijing, China
Haibin Yu
Beijing You'an Hospital, Beijing Medical University
Hao Wu
Beijing You'an Hospital, Beijing Medical University
24 participants (actual enrollment reported by the registry).
First Submitted
April 2, 2022
First Posted
April 27, 2022
Study Start
June 10, 2022
Actual (reported)Safety and Effects of Using Prime-boost HIVIS DNA and MVA-CMDR Vaccine Regimens With or Without Toll-like Receptor 4 Agonist on HIV Reservoirs in Perinatally HIV Infected Children and Youth
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.
Contact the study team to confirm eligibility.
Primary Completion
June 7, 2023
Actual (reported)Study Completion
September 7, 2023
Actual (reported)Last Updated
May 11, 2026
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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