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Can two shots replace daily HIV pills? trial tests new injectable combo

NCT ID NCT07816250

Disease control Sponsor: ViiV Healthcare 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether a two-drug injectable regimen can control HIV in adults who have not yet started treatment. The trial pairs an experimental drug called VH4011499 with cabotegravir, an existing injectable HIV medicine, and compares different dose combinations against a standard daily oral pill. About 200 adults with HIV will join. The main goal is to see how many participants reach very low levels of virus in their blood.

What this could mean

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

Active substance
an experimental injectable HIV drug called VH4011499, given with cabotegravir
What this could lead to
If it works, this could offer a two-drug injectable option for people starting HIV treatment, potentially reducing how often they need doses compared with daily pills.
What could go wrong
This is a mid-stage trial with about 200 participants, so it may not show the regimen works as well as standard daily pills. Injectables can cause injection site reactions, and long-term safety and resistance risks are not yet known.

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2032

An estimate. End dates often move.

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: * Participant must be at least 18 years of age (or older, if required for adults by local regulations). * Screening CD4+ T-cell count ≥ 200 cells/µL. * Documented HIV-1 infection and screening plasma HIV-1 RNA ≥ 1 000 and ≤ 100 000 copies/mL. * Treatment-naïve. Prior use of oral pre-exposure prophylaxis (PrEP) or oral post-exposure prophylaxis (PEP) that is not INSTI or CAI based is permitted. * Body weight ≥ 50.0 kg (110 lbs) for participants assigned male at birth and ≥ 45.0 kg (99 lbs) for participants assigned female at birth. * Agrees to adequate birth control if a participant of childbearing potential Exclusion Criteria: * Participants with acute HIV-1 infection * Prior exposure to any HIV-1 capsid inhibitor or any HIV-1 INSTI for any reason is prohibited. * Participants with known or suspected presence of major virologic resistance mutations to study drugs * Unstable liver disease * Participants with HCV co-infection * Participant has evidence of chronic active HBV infection * Clinically significant cardiovascular disease

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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 infections

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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