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Injectable HIV treatment tested over five years in thousands of patients

NCT ID NCT07703748

Disease control Sponsor: FUNDACIÓN HOSPITAL UNIVERSITARIO INFANTA LEONOR Y DEL HOSPITAL UNIVERSITARIO DEL SURESTE 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study follows over 3,300 people with HIV in Spain who switched from daily oral medication to a long-acting injectable combination of cabotegravir and rilpivirine. Researchers track how well the injections control the virus, how long patients stay on treatment, and any side effects over five years. The goal is to see if this convenient shot-based regimen works safely in real-world settings, including in older adults, women, and people with other health conditions.

What this could mean

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

Active substance
a long-acting injectable combination of cabotegravir and rilpivirine
What this could lead to
If successful, this study could confirm that long-acting injectable HIV treatment works well over many years in diverse patient groups, offering a convenient alternative to daily pills.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient selection or real-world factors. Long-term safety and effectiveness are still being evaluated.

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

3,346 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Apr 2029

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 (≥18 years) living with HIV-1 receiving routine care in Spain who achieved virological suppression on oral antiretroviral therapy and switched to long-acting intramuscular cabotegravir plus rilpivirine (CAB+RPV LA) according to routine clinical practice. Participants are enrolled from 58 hospitals across Spain in a nationwide ambispective observational cohort. The study includes a broad and representative real-world population, including older adults, women, migrants, people with obesity, individuals with multimorbidity, and other clinically relevant subgroups. Approximately 4,000 participants are expected to be included and followed for up to 5 years after treatment initiation.

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: * Adults aged ≥18 years. * Documented HIV-1 infection. * Receiving oral antiretroviral therapy with plasma HIV-1 RNA \<50 copies/mL at the time of switching to long-acting cabotegravir plus rilpivirine (CAB+RPV LA). * No current or previous evidence of resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or integrase strand transfer inhibitors (INSTIs), and no previous virological failure with these drug classes. * Received at least one injection of CAB+RPV LA before January 1, 2025. * Able to understand and provide written informed consent. Exclusion Criteria: * Any contraindication to CAB+RPV LA according to the approved product labeling. * Previous exposure to long-acting CAB+RPV within an interventional clinical trial. * Active hepatitis B infection (HBsAg positive). * Pregnancy or breastfeeding.

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease Injection Site Reaction

As listed by the trial registrant

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

HIV-1 infection in adults Human immunodeficiency virus infection (HIV)

Contacts and locations

Locations

  • Hospital Universitario de Burgos

    Burgos, Spain