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New Long-Acting HIV combo shot aims to simplify treatment

NCT ID NCT07402044

Disease control Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how well a long-acting combination of two HIV drugs (cabotegravir and lenacapavir) works in 50 adults with HIV-1. Participants either already take this treatment or will start it by doctor's order. The main goal is to see if the virus stays suppressed (below 50 copies/mL) and to monitor side effects and immune changes over one year.

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.

Participants

About 50 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

people living with HIV (PLHIV) in France, receiving long-acting dual therapy with cabotegravir/lenacapavir for at least 48 weeks, comprising: (i) a retrospective component, including patients who started this treatment from July 2024 until the last available follow-up data collection; (ii) a prospective component, including patients for whom a medical decision to initiate this treatment is made during a 12-month recruitment period, with a planned follow-up of 48 weeks.

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.

* Age ≥18 years * HIV-1 infection * Patients who started taking cabotegravir combined with lenacapavir between July 2024 and the one-year follow-up, or who are due to start taking the CAB/LEN combination. * Patients who are due to start the CAB/LEN combination following a medical decision. Exclusion Criteria: * Participants' objection to the use of follow-up data

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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.

Cabotegravir Lenacapavir

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Archet 1Hospital

    Nice, France

  • Bichat Claude Bernard Hospital

    Paris, France

  • Franco-British Hospital (Fbh)

    Levallois-Perret, France

  • Hotel Dieu Hospital

    Nantes, France

  • Hotel Dieu Hospital

    Paris, France

  • Necker Hospital

    Paris, France

  • Pellegrin Hospital

    Bordeaux, France

  • Pitié Salpêtrière Hospital

    Paris, France

  • Raymond poincaré Hospital

    Garches, France

  • Saint André Hospital

    Bordeaux, France

  • Saint Antoine Hospital

    Paris, France

  • Tourcoing Hospital

    Tourcoing, France

  • Victor Dupuy Hospital

    Argenteuil, France

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