HIV InfectionsPhase 1NCT04592315
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients
A Phase 1 study testing Lipovirtide Injection in people with HIV Infections, run by Shanxi Kangbao Biological Product Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety, tolerability of single dose lipovirtide injection in HIV-infected individuals without prior antiviral treatment, and to investigate the pharmacokinetic characteristics of infected patients. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Lipovirtide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 23 Jan 2021to 11 Jul 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged from 18 to 60 (include 18 and 60)；
- Body mass index (BMI) [weight (kg)/ height 2(m2)] is from 18.0 to 26.0（include 18.0 and 26.0），male weight≥50kg，female weight≥45kg；
- Confirmed HIV-1 infection；
- HIV viral load ≥ 1000 copies/mL；
- Patients who have no birth plan within 2 weeks before the screening and 3 months after the end of the trial, consenting to take effective non-drug contraceptive measures during the trial period；
- Understand the purpose of and procedures required for the study and having confirmed they are willing to participate in the study by signing the informed consent document.
Who cannot join
- Patients in the acute infection stage;
- Confirmed AIDS patients；
- Patients who have received antiviral therapy and/or have been vaccinated against HIV；
- HBsAg is (+), and/or anti-HCV is (+)；
- Abnormal liver function tests (ALT and / or AST> 3ULN, or total bilirubin> 2ULN)；
- Glomerular filtration rate <70mL/min/1.73m2, or creatinine ≥ULN；
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- Patients who is currently suffering from a more serious chronic diseases, metabolic diseases (such as diabetes), neurological and mental diseases；
- Patients who have previous history of pancreatitis；
- Females who are pregnant or breastfeeding, or females of childbearing age who are unable to take contraception as required;
- Allergic constitution or known allergy to the components of study drug；
- With a history of smoking addiction within 12 months before screening (average number≥5 cigarettes per day)；
- With a history of alcohol abuse within 12 months before screening (average drinking≥14 units of alcohol per week: 1 unit = 285mL beer, 25mL spirits, or 150mL wine) or those who have a positive alcohol breath test before enrollment；
- With a history of drug abuse within 12 months before screening or those who tested positive for addictive substances before enrollment；
- Patients who have participated in other investigational drug study within 3 months before screening (except for traditional Chinese medicine）；
- Other factors that the investigators consider unsuitable for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing You'an Hospital, Beijing Medical University
Beijing, Beijing Municipality
About this study
Official title: A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients Without Prior Antiviral Therapy
To evaluate the safety, tolerability of single dose lipovirtide injection in HIV-infected individuals without prior antiviral treatment, and to investigate the pharmacokinetic characteristics of infected patients.
- Conditions
- HIV Infections
- Being tested
- Lipovirtide 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 InjectionDrug
Single dosage of Lipovirtide Injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dose 5 mg Receives: Drug: Lipovirtide Injection |
| 2 | Experimental | Dose 10 mg Receives: Drug: Lipovirtide Injection |
| 3 | Experimental | Dose 20 mg Receives: Drug: Lipovirtide Injection |
| 4 | Experimental | Dose 40 mg Receives: Drug: Lipovirtide Injection |
| 5 | Experimental | Dose 60 mg Receives: Drug: Lipovirtide Injection |
| 6 | Experimental | Dose 80 mg Receives: Drug: Lipovirtide Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Related Adverse Events as Assessed by DAIDS v1.0
Evaluation of safety and tolerability after single dose of injectable Lipivirtide in HIV-infected patients not receiving antiretroviral therapy
Measured: Day 1 to Day 15
Secondary outcomes (2)
Pharmacokinetic characteristics- Area Under the Plasma Concentration Versus Time Curve (AUC)
Evaluation of the pharmacokinetic properties of injectable Lipovirtide after single dose in HIV-infected patients not receiving antiretroviral therapy, to obtain pharmacokinetic parameters.
Measured: Area Under the Plasma Concentration Versus Time Curve (AUC) of Lipovirtide could have a time frame of "0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 30, 36h, 4, 72, 96, 120, 168 hours post-dose."
Pharmacokinetic characteristics-Peak plasma concentration (Cmax)
Evaluation of the pharmacokinetic properties of injectable Lipovirtide after single dose in HIV-infected patients not receiving antiretroviral therapy, to obtain pharmacokinetic parameters.
Measured: Peak plasma concentration (Cmax) of Lipovirtide could have a time frame of "0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 30, 36h, 4, 72, 96, 120, 168 hours post-dose."
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start23 Jan 2021
- Primary completion2 May 2023
- Study completion11 Jul 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
- 46 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
- Haibin Yu, MD, Principal investigator, Beijing You'an Hospital, Beijing Medical UniversityHao Wu, MD, Principal investigator, Beijing You'an Hospital, Beijing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592315
- Sponsor's protocol ID
- KB-LP-80-101
- Status last verified
- Apr 2026
- First submitted
- 30 Sep 2020
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients Without Prior Antiviral Therapy
- ClinicalTrials.gov ID
- NCT04592315
- Acronym / sponsor ID
- KB-LP-80-101
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Shanxi Kangbao Biological Product Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Institute of Pathogen Biology, Beijing, China
- Study start
- 23 Jan 2021 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 19 Oct 2020 (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.
To evaluate the safety, tolerability of single dose lipovirtide injection in HIV-infected individuals without prior antiviral treatment, and to investigate the pharmacokinetic characteristics of infected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Lipovirtide InjectionDose 5 mg |
| 2 | Experimental | Drug: Lipovirtide InjectionDose 10 mg |
| 3 | Experimental | Drug: Lipovirtide InjectionDose 20 mg |
| 4 | Experimental | Drug: Lipovirtide InjectionDose 40 mg |
| 5 | Experimental | Drug: Lipovirtide InjectionDose 60 mg |
| 6 | Experimental | Drug: Lipovirtide InjectionDose 80 mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female aged from 18 to 60 (include 18 and 60)；
- Body mass index (BMI) [weight (kg)/ height 2(m2)] is from 18.0 to 26.0（include 18.0 and 26.0），male weight≥50kg，female weight≥45kg；
- Confirmed HIV-1 infection；
- HIV viral load ≥ 1000 copies/mL；
- Patients who have no birth plan within 2 weeks before the screening and 3 months after the end of the trial, consenting to take effective non-drug contraceptive measures during the trial period；
Key exclusion criteria (15 listed)
- Patients in the acute infection stage;
- Confirmed AIDS patients；
- Patients who have received antiviral therapy and/or have been vaccinated against HIV；
- HBsAg is (+), and/or anti-HCV is (+)；
- Abnormal liver function tests (ALT and / or AST> 3ULN, or total bilirubin> 2ULN)；
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 InjectionSingle dosage of Lipovirtide Injection | Drug | 1, 2, 3, 4, 5, 6 |
Primary outcome
Number of Participants with Treatment-Related Adverse Events as Assessed by DAIDS v1.0
Time frame: Day 1 to Day 15
Evaluation of safety and tolerability after single dose of injectable Lipivirtide in HIV-infected patients not receiving antiretroviral therapy
2 secondary outcomes
Pharmacokinetic characteristics- Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: Area Under the Plasma Concentration Versus Time Curve (AUC) of Lipovirtide could have a time frame of "0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 30, 36h, 4, 72, 96, 120, 168 hours post-dose."
Pharmacokinetic characteristics-Peak plasma concentration (Cmax)
Time frame: Peak plasma concentration (Cmax) of Lipovirtide could have a time frame of "0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 30, 36h, 4, 72, 96, 120, 168 hours post-dose."
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, MD principal investigator
Beijing You'an Hospital, Beijing Medical University
Hao Wu, MD 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 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 6 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?
Number of Participants with Treatment-Related Adverse Events as Assessed by DAIDS v1.0 (time frame: Day 1 to Day 15). 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 11 May 2026.