New HIV injection shows promise in early safety trial
NCT ID NCT05349968
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested multiple doses of an injectable drug called lipovirtide in 24 adults with HIV who had never taken antiretroviral therapy. The main goal was to check safety and how the drug moves through the body, with a secondary look at whether it can lower HIV levels. The study is complete, but results are not yet public.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lipovirtide
- What this could lead to
- If this works, it could point toward a new injectable treatment option for HIV that helps control the virus without daily pills.
- What could go wrong
- This is a very early Phase 1 trial with only 24 participants, so results may not apply broadly. The drug may prove unsafe or ineffective in larger studies.
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
-
24 people
The number who actually took part.
- Started
-
Jun 2022
- Finished
-
Sep 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
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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. 18\~60 years old (including the critical value), male and female are not limited. 2. Body mass index BMI \[weight (kg)/height2 (m2)\] is 18.0\~28.0 (including the critical value), male weight should be ≥50kg, female weight should be ≥45kg. 3. Diagnosed with HIV-1 infection. 4. Those who did not plan to have children within 2 weeks prior to screening and within 3 months after the end of the trial and who agreed to use effective non-pharmacological contraception during the trial. 5. Subjects should fully understand the purpose, nature and methods of the test and the possible adverse effects and voluntarily participate in this test. Exclusion Criteria: Subjects meeting any of the following criteria will not be allowed to enter the trial 1. The presence of any of the following 1)Unexplained persistent irregular fever of 38°C or more for \>1 month. 2)Diarrhea (stools more than 3 times/day), \>1 month. 3)Weight loss of 10% or more within 6 months. 4)Recurrent oral fungal infections. 5)Recurrent herpes simplex virus infection or herpes zoster virus infection. 6)Pneumocystis carinii pneumonia (PCP). 7)Recurrent bacterial pneumonia. 8)Active tuberculosis or non-tuberculous mycobacteriosis. 9)Deep fungal infection. 10)Occupational lesions of the central nervous system. 11)Dementia in young and middle-aged adults. 12)Active cytomegalovirus (CMV) infection. 13)Toxoplasma encephalopathy. 14)Malnefield basket disease. 15)Recurrent sepsis. 16)Kaposi's sarcoma, lymphoma. 2. Patients who have received antiviral therapy and/or HIV vaccination; 3. HBsAg of (+), and/or anti-HCV of (+); 4. Abnormal liver function (ALT/AST\>3XULN, or TBIL\>2XULN); 5. Creatinine clearance\<70mL/min (Equation of calculation: Cockcroft-Gault) 6. Existing severe chronic disease, metabolic disease (such as diabetes), neurological and psychiatric disease; 7. History of pancreatitis; 8. Regnant, lactating women and women of childbearing age who cannot use contraception as required; 9. People with allergies or known allergies to the ingredients of this medicine; 10. People with a history of smoking within 12 months before screening (the average number of cigarettes smoked per day is 35.); 11. People with a history of alcoholism within 12 months before screening(Drink N14 units of alcohol per week on average: 1 unit = 285mL of beer, or 25mL of spirits, or 150mL of wine) or positive alcohol breath test before enrollment; 12. People with have a history of drug abuse within 12 months before screening or those who tested positive for addictive substances before enrollment; 13. Participated in other drug trials within 3 months before screening; 14. The investigator believes that the subject has other conditions that are not suitable for participating in 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, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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