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New study checks if Long-Acting HIV shots work for all subtypes

NCT ID NCT07370649

Disease control Sponsor: Pomeranian Medical University Szczecin Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 injectable HIV treatment works in people with HIV-1 subtype A6, a common type in Eastern Europe. Researchers will compare medical records from 250 adults in Poland, Germany, and the Czech Republic who have already received the shots. The goal is to see if knowing your HIV subtype helps doctors choose the best treatment.

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 250 people

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

Started

May 2026

Expected to finish

Mar 2027

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

The study population consists of adults aged 18 years or older living with HIV-1 infection who have received long-acting injectable cabotegravir plus rilpivirine (CAB/RPV LA) as part of routine clinical care. Participants are treatment-experienced and include individuals with suppressed or unsuppressed HIV-1 viral load at the time of treatment initiation. Patients are identified retrospectively from electronic medical records at participating HIV treatment centers in Poland, Germany, and the Czech Republic. Participants are grouped according to documented HIV-1 subtype (subtype A6, subtype B, or unknown subtype). Individuals with known subtype A6 are matched with individuals with subtype B based on selected clinical characteristics, while participants with unknown subtype are analyzed as an unmatched descriptive cohort. The study includes a broad, real-world patient population without upper age limits or sex-based restrictions, reflecting routine clinical practice in participating ce

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: * Confirmed diagnosis of HIV-1 infection * Age ≥18 years at the time of initiation of long-acting cabotegravir plus rilpivirine (CAB/RPV LA) * Received at least one dose of CAB/RPV LA as part of routine clinical care * Availability of relevant clinical data in medical records for retrospective analysis * Signed informed consent for use of clinical data * Agreement to provide an additional blood sample for proviral DNA genotyping, if HIV-1 subtype was unknown at treatment initiation Exclusion Criteria: \- Lack of patient consent for use of clinical data for research purposes

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease

As listed by the trial registrant

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

HIV-1 subtype A6 infection HIV-1 subtype B infection Human immunodeficiency virus (HIV)-1 infection Virologically suppressed HIV-1 infection receiving long-acting antiretroviral therapy

How to take part

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

  1. The places running it

    7 sites in 3 countries. 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

  • Hospital Na Bulovce Praque HIV Centre, Department of Infectious Diseases

    RECRUITING

    Prague, Czechia

  • Katedra Chorób Zakaźnych i Niedoborów Immunologicznych

    NOT_YET_RECRUITING

    Szczecin, West Pomeranian Voivodeship, 71-455, Poland

  • MainFachArzt

    RECRUITING

    Frankfurt, Germany

  • Szpitale Pomorskie

    RECRUITING

    Gdansk, Poland

  • Wojewódzki Szpital Obserwacyjno-Zakaźny

    RECRUITING

    Bydgoszcz, Poland

  • Wojewódzki Szpital Zakaźny w Warszawie

    RECRUITING

    Warsaw, Poland

  • Wrocławskie Centrum Zdrowia

    RECRUITING

    Wroclaw, Poland