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New HIV drug lipovirtide passes first safety check in small study

NCT ID NCT04592315

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

46 people

The number who actually took part.

Started

Jan 2021

Finished

Jul 2023

Lead sponsor

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Beijing You'an Hospital, Beijing Medical University

    Beijing, Beijing Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.