New HIV drug lipovirtide passes first safety check in small study
NCT ID NCT04592315
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a single injection of a new drug, lipovirtide, in 46 HIV-positive adults who had never taken antiviral medication. The main goal was to check if the drug is safe and how the body processes it. This is a first step toward finding new treatments to control HIV.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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46 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Jul 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female aged from 18 to 60 (include 18 and 60); 2. 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; 3. Confirmed HIV-1 infection; 4. HIV viral load ≥ 1000 copies/mL; 5. 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; 6. 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. Exclusion Criteria: 1. Patients in the acute infection stage; 2. Confirmed AIDS patients; 3. Patients who have received antiviral therapy and/or have been vaccinated against HIV; 4. HBsAg is (+), and/or anti-HCV is (+); 5. Abnormal liver function tests (ALT and / or AST\> 3ULN, or total bilirubin\> 2ULN); 6. Glomerular filtration rate \<70mL/min/1.73m2, or creatinine ≥ULN; 7. Patients who is currently suffering from a more serious chronic diseases, metabolic diseases (such as diabetes), neurological and mental diseases; 8. Patients who have previous history of pancreatitis; 9. Females who are pregnant or breastfeeding, or females of childbearing age who are unable to take contraception as required; 10. Allergic constitution or known allergy to the components of study drug; 11. With a history of smoking addiction within 12 months before screening (average number≥5 cigarettes per day); 12. 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; 13. With a history of drug abuse within 12 months before screening or those who tested positive for addictive substances before enrollment; 14. Patients who have participated in other investigational drug study within 3 months before screening (except for traditional Chinese medicine); 15. Other factors that the investigators consider unsuitable for the trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing You'an Hospital, Beijing Medical University
Beijing, Beijing Municipality, China
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Other studies related to the condition(s) this trial covers.
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