HIVPhase 2NCT06061536
Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients.
A Phase 2 study testing Lipovirtide 10mg, Lipovirtide 40mg and Lipovirtide 60mg in people with HIV, run by Shanxi Kangbao Biological Product Co., Ltd. at 1 site in China.
Trial summary
A randomized, controlled, open-label, dose-exploration study to assess the effectiveness and safety of Lipovirtide combined with nucleoside drugs in HIV-infected patients who have not received antiviral treatment before. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Lipovirtide 10mg, Lipovirtide 40mg and Lipovirtide 60mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2023to 24 Jan 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age≥18 years (including the critical value) when signed the informed consent form ,.male or female.
- Untreated, confirmed HIV-1 infected patients;
- HIV RNA viral load≥1000 copies/mL；
- CD4+ T cell counts≥200 cells/mm3；
- Subjects who have no plans for conception within the 2 weeks prior to screening and 3 months after the end of the trial, and who agree to use effective non-pharmacological contraceptive measures during the trial;
- Sign informed consent prior to the test and fully understand the purpose, nature, methods, and possible adverse reactions, and be willing to participate in the study.
Who cannot join
- Subjects with an allergy history or hypersensitivity to any component or excipient of the investigational drug;
- Subjects with severe opportunistic infections or opportunistic tumors;
- Subjects with confirmed AIDS or in the acute infection stage;
- Hepatitis B virus surface antigen (HBsAg)/hepatitis C virus antibody (HCV-Ab) Positive;
- ALT and/or AST≥5×ULN；
- ALT≥3×ULN and total bilirubin≥2×ULN (direct bilirubin/total bilirubin>35%;
Show all 12Show fewer
- GFR<70ml/min/1.73m2 (estimated from creatinine values based on the CKD-EPI Creatinine 2009 Equation), or creatinine ≥ULN;
- Subjects with severe and uncontrolled chronic diseases, metabolic diseases, neurological and psychiatric diseases;
- Subjects with a pancreatitis disease history ever before;
- Subjects who are pregnant or lactating women;
- Subjects with a history of drug abuse, alcoholism, or substance misuse;
- Any clinical trials in the 3 months prior to the screening of the trial; 13）Subjects may not be able to complete this study or other investigators' judgment for other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality, 300000
About this study
Official title: A Randomized, Controlled, Open-label, Dose-exploration Study to Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients Who Have Not Received Antiviral Treatment Before.
A randomized, controlled, open-label, dose-exploration study to assess the effectiveness and safety of Lipovirtide combined with nucleoside drugs in HIV-infected patients who have not received antiviral treatment before.
Read the detailed description
multiple sites, randomized, open-label, controlled study design. 64 eligible subjects will be enrolled in this study, and they will be randomly assigned to each group in a 1:1:1:1 proportion, 16 subjects in each group. Each site will compete to enroll subjects.
The 4 groups are as follows： Group A：Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）； Group B：Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）； Group C：Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily）； Group D：DTG +3TC + TDF（once daily）.
- Conditions
- HIV
- Being tested
- Lipovirtide 10mg, Lipovirtide 40mg, Lipovirtide 60mg, DTG
- Keywords
- Lipovirtide, HIV, nucleoside drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipovirtide 10mgDrug
Also called 3TC, TDF
Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）；
Lipovirtide 40mgDrug
Also called 3TC, TDF
Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）；
Lipovirtide 60mgDrug
Also called 3TC, TDF
Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily）；
DTGDrug
Also called 3TC, TDF
DTG +3TC + TDF（once daily）.
| Study group | Role | What they receive |
|---|---|---|
| Group A：Lipovirtide 10mg+3TC+TDF | Experimental | Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily） Receives: Drug: Lipovirtide 10mg |
| Group B：Lipovirtide 40mg+3TC+TDF | Experimental | Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily） Receives: Drug: Lipovirtide 40mg |
| Group C：Lipovirtide 60mg+3TC+TDF | Experimental | Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily） Receives: Drug: Lipovirtide 60mg |
| Group D：DTG +3TC + TDF | Experimental | DTG +3TC + TDF（once daily） Receives: Drug: DTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV-1 RNA <50 copies/ml
The proportion of subjects with HIV-1 RNA <50 copies/ml at Day 169 after receiving Lipovirtide administration.
Measured: at Day 169 after receiving Lipovirtide administration.
Secondary outcomes (43)
HIV-1 RNA <50 copies/ml
The proportion of subjects with HIV-1 RNA <50 copies/ml at Day 29、Day 85、Day 169 after receiving Lipovirtide administration
Measured: at Day 29、Day 85、Day 169 after receiving Lipovirtide administration
HIV-1 RNA <400 copies/ml
The proportion of subjects with HIV-1 RNA <400 copies/ml at Day 85、Day 169 after receiving Lipovirtide administration
Measured: at Day 85、Day 169 after receiving Lipovirtide administration
CD4+ T-cell and CD8+ T-cell
The changes in CD4+ T-cell and CD8+ T-cell counts compared to baseline at Day 85 and Day 169 after receiving Lipovirtide administration
Measured: at Day 85 and Day 169 after receiving Lipovirtide administration
HIV-1 RNA <50 copies/ml
The time required to achieve viral suppression (HIV-1 RNA <50 copies/ml)
Measured: Within Day 169 of after receiving Lipovirtide administration
HIV-1 RNA
The temporal changes in log-transformed HIV-1 RNA levels compared to baseline
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in respiration rate of Vital Signs
Respiration rate in times / minute
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in blood pressure of Vital Signs
Blood pressure in mmHg
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in body temperature of Vital Signs
Body temperature in Celsius degree
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in ECG PR intervalThe cardiac rhythm is showed in 12 Leads
Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in ECG QRS intervalThe cardiac rhythm is showed in 12 Leads
Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in ECG QT intervalThe cardiac rhythm is showed in 12 Leads
Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in Blood lactate of Laboratory Examination
Changes of blood lactate will be recorded
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in Pregnancy test of Laboratory Examination
Pregnancy test will be tested in female subjects
Measured: Within Day 169 of after receiving Lipovirtide 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 Day 169 of after receiving Lipovirtide 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 Day 169 of after receiving Lipovirtide administration
Changes from baseline in neutrophil count of Laboratory Examination
Neutrophil count in whole blood is reported in the form of number
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in lymphocyte count of Laboratory Examination
Lymphocyte count in whole blood is reported in the form of number
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in platelet count of Laboratory Examination
Platelet count in whole blood is reported in the form of number.
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in hemoglobin of Laboratory Examination
Changes of hemoglobin concentration（g/dL）in whole blood will be recorded.
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in PT of Laboratory Examination
Prothrombin time (PT) is a screening test for exogenous coagulation factors
Measured: Within Day 169 of after receiving Lipovirtide 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 Day 169 of after receiving Lipovirtide administration
Changes from baseline in APTT of Laboratory Examination
Changes of total bilirubin concentration (μmol/L) in serum will be recorded
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in direct bilirubin of Laboratory Examination
Changes of direct bilirubin concentration (μmol/L) in serum will be recorded.
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in ALT of Laboratory Examination
Changes of ALT concentration (U/L) in serum will be recorded
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in AST of Laboratory Examination
Changes of AST concentration (U/L) in serum will be recorded
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in total protein of Laboratory Examination.
Changes of total protein concentration (g/L) in serum will be recorded.
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in albumin of Laboratory Examination
Changes of albumin concentration (g/L) in serum will be recorded
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in creatinine of Laboratory Examination
Changes of creatinine concentration (μmol/L) in serum will be recorded
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in glucose of Laboratory Examination
Changes of glucose concentration (mmol/L) in serum will be recorded.
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in potassium of Laboratory Examination
Changes of potassium concentration (mmol/L) in serum will be recorded
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in sodium of Laboratory Examination
Changes of sodium concentration (mmol/L) in serum will be recorded
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in chlorine of Laboratory Examination
Changes of chlorine concentration (mmol/L) in serum will be recorded
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in urine specific gravity of Laboratory Examination
Changes of urine specific gravity will be recorded.
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in urine pH of Laboratory Examination
Changes of urine pH value will be recorded
Measured: Within Day 169 of after receiving Lipovirtide 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 Day 169 of after receiving Lipovirtide 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 Day 169 of after receiving Lipovirtide 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 Day 169 of after receiving Lipovirtide 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 Day 169 of after receiving Lipovirtide 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 Day 169 of after receiving Lipovirtide administration
Changes from baseline in LDH of Laboratory Examination
Changes of LDH concentration (U/L) in serum will be recorded.
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in Triglyceride of Laboratory Examination
Changes of Triglyceride concentration (mmol/L) in serum will be recorded
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in ALP of Laboratory Examination
Changes of ALP concentration (U/L) in serum will be recorded
Measured: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in CHOL of Laboratory Examination
Changes of CHOL concentration (mmol/L) in serum will be recorded
Measured: Within Day 169 of after receiving Lipovirtide administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start2 Nov 2023
- Primary completion29 Nov 2024
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanxi Kangbao Biological Product Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute of Pathogen Biology, Beijing, China
- Responsible party
- Sponsor
- Investigators
- Ping Ma, Doctor, Study director, Tianjin Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061536
- Sponsor's protocol ID
- SXKB-LP-80-201
- Status last verified
- May 2026
- First submitted
- 18 Sep 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label, Dose-exploration Study to Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients Who Have Not Received Antiviral Treatment Before.
- ClinicalTrials.gov ID
- NCT06061536
- Acronym / sponsor ID
- SXKB-LP-80-201
- Conditions
- HIV
- Keywords
- Lipovirtide, HIV, nucleoside drugs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Shanxi Kangbao Biological Product Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Institute of Pathogen Biology, Beijing, China
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 29 Sep 2023 (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.
A randomized, controlled, open-label, dose-exploration study to assess the effectiveness and safety of Lipovirtide combined with nucleoside drugs in HIV-infected patients who have not received antiviral treatment before.
Detailed description
multiple sites, randomized, open-label, controlled study design. 64 eligible subjects will be enrolled in this study, and they will be randomly assigned to each group in a 1:1:1:1 proportion, 16 subjects in each group. Each site will compete to enroll subjects.
The 4 groups are as follows： Group A：Lipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）； Group B：Lipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）； Group C：Lipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily）； Group D：DTG +3TC + TDF（once daily）.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A：Lipovirtide 10mg+3TC+TDF | Experimental | Drug: Lipovirtide 10mgLipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily） |
| Group B：Lipovirtide 40mg+3TC+TDF | Experimental | Drug: Lipovirtide 40mgLipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily） |
| Group C：Lipovirtide 60mg+3TC+TDF | Experimental | Drug: Lipovirtide 60mgLipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily） |
| Group D：DTG +3TC + TDF | Experimental | Drug: DTGDTG +3TC + TDF（once daily） |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age≥18 years (including the critical value) when signed the informed consent form ,.male or female.
- Untreated, confirmed HIV-1 infected patients;
- HIV RNA viral load≥1000 copies/mL；
- CD4+ T cell counts≥200 cells/mm3；
- Subjects who have no plans for conception within the 2 weeks prior to screening and 3 months after the end of the trial, and who agree to use effective non-pharmacological contraceptive measures during the trial;
Key exclusion criteria (12 listed)
- Subjects with an allergy history or hypersensitivity to any component or excipient of the investigational drug;
- Subjects with severe opportunistic infections or opportunistic tumors;
- Subjects with confirmed AIDS or in the acute infection stage;
- Hepatitis B virus surface antigen (HBsAg)/hepatitis C virus antibody (HCV-Ab) Positive;
- ALT and/or AST≥5×ULN；
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 10mgAlso: 3TC, TDFLipovirtide 10mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）； | Drug | Group A：Lipovirtide 10mg+3TC+TDF |
| Lipovirtide 40mgAlso: 3TC, TDFLipovirtide 40mg+3TC+TDF（LP-80：once a week；3TC+TDF：once daily）； | Drug | Group B：Lipovirtide 40mg+3TC+TDF |
| Lipovirtide 60mgAlso: 3TC, TDFLipovirtide 60mg+3TC+TDF（LP-80：once every 2 weeks；3TC+TDF：once daily）； | Drug | Group C：Lipovirtide 60mg+3TC+TDF |
| DTGAlso: 3TC, TDFDTG +3TC + TDF（once daily）. | Drug | Group D：DTG +3TC + TDF |
Primary outcome
HIV-1 RNA <50 copies/ml
Time frame: at Day 169 after receiving Lipovirtide administration.
The proportion of subjects with HIV-1 RNA <50 copies/ml at Day 169 after receiving Lipovirtide administration.
43 secondary outcomes
HIV-1 RNA <50 copies/ml
Time frame: at Day 29、Day 85、Day 169 after receiving Lipovirtide administration
HIV-1 RNA <400 copies/ml
Time frame: at Day 85、Day 169 after receiving Lipovirtide administration
CD4+ T-cell and CD8+ T-cell
Time frame: at Day 85 and Day 169 after receiving Lipovirtide administration
HIV-1 RNA <50 copies/ml
Time frame: Within Day 169 of after receiving Lipovirtide administration
HIV-1 RNA
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in respiration rate of Vital Signs
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in blood pressure of Vital Signs
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in body temperature of Vital Signs
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in ECG PR intervalThe cardiac rhythm is showed in 12 Leads
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in ECG QRS intervalThe cardiac rhythm is showed in 12 Leads
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in ECG QT intervalThe cardiac rhythm is showed in 12 Leads
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in Blood lactate of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in Pregnancy test of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in red blood cell count of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in white blood cell count of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in neutrophil count of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in lymphocyte count of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in platelet count of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in hemoglobin of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in PT of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in INR of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in APTT of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in direct bilirubin of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in ALT of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in AST of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in total protein of Laboratory Examination.
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in albumin of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in creatinine of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in glucose of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in potassium of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in sodium of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in chlorine of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in urine specific gravity of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in urine pH of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in urine glucose of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in urine protein of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in urine ketone body of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in urine white blood cell of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in urine occult blood of Laboratory Examination.
Time frame: Within Day 169 of after receiving Lipovirtide administration
Changes from baseline in LDH of Laboratory Examination
Time frame: Within Day 169 of after receiving Lipovirtide 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 13 May 2026.
- Individual participant dataSharing planned: No
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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.
Ping Ma, Doctor study director
Tianjin Second People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lipovirtide 10mg, Lipovirtide 40mg and Lipovirtide 60mg in people with HIV, 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 6 inclusion and 12 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 13 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
HIV-1 RNA <50 copies/ml (time frame: at Day 169 after receiving Lipovirtide administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2026.