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Could a weekly shot replace daily HIV pills? new trial hints at possibility

NCT ID NCT06061536

Disease control Sponsor: Shanxi Kangbao Biological Product Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 2 trial tested a new drug called lipovirtide, given as a weekly or biweekly injection, along with daily oral HIV medications. The study enrolled 64 HIV-positive adults who had never taken antiviral drugs before. Researchers measured how many participants had undetectable virus levels after 169 days, aiming to find the best dose and check safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lipovirtide (a weekly or biweekly injection) combined with daily oral nucleoside drugs (3TC and TDF)
What this could lead to
If it works, this could offer a less frequent treatment option for HIV, reducing the burden of daily pills.
What could go wrong
This is a small, early Phase 2 study with only 64 participants. The results may not apply to everyone, and the best dose and safety profile are still being determined.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

64 people

The number who actually took part.

Started

Nov 2023

Finished

Jan 2025

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 years and older

Sex

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. age≥18 years (including the critical value) when signed the informed consent form ,.male or female. 2. Untreated, confirmed HIV-1 infected patients; 3. HIV RNA viral load≥1000 copies/mL； 4. CD4+ T cell counts≥200 cells/mm3； 5. 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; 6. 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. Exclusion Criteria: 1. Subjects with an allergy history or hypersensitivity to any component or excipient of the investigational drug; 2. Subjects with severe opportunistic infections or opportunistic tumors; 3. Subjects with confirmed AIDS or in the acute infection stage; 4. Hepatitis B virus surface antigen (HBsAg)/hepatitis C virus antibody (HCV-Ab) Positive; 5. ALT and/or AST≥5×ULN； 6. ALT≥3×ULN and total bilirubin≥2×ULN (direct bilirubin/total bilirubin\>35%; 7. GFR\<70ml/min/1.73m2 (estimated from creatinine values based on the CKD-EPI Creatinine 2009 Equation), or creatinine ≥ULN; 8. Subjects with severe and uncontrolled chronic diseases, metabolic diseases, neurological and psychiatric diseases; 9. Subjects with a pancreatitis disease history ever before; 10. Subjects who are pregnant or lactating women; 11. Subjects with a history of drug abuse, alcoholism, or substance misuse; 12. 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.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV

Contacts and locations

Locations

  • Tianjin Second People's Hospital

    Tianjin, Tianjin Municipality, 300000, China

More trials for these conditions

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