An observational study in Human Immunodeficiency Virus (HIV)-1 Infection, HIV-1 Subtype A6 Infection and HIV-1 Subtype B Infection, sponsored by Pomeranian Medical University Szczecin. Recruiting at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Pomeranian Medical University Szczecin · Observational
This study evaluates the real-world effectiveness and safety of a long-acting injectable HIV treatment consisting of cabotegravir and rilpivirine in people living with HIV-1. The focus is on individuals with HIV-1 subtype A6, which is common in Eastern Europe and among people who acquired HIV in that region, and on comparison with individuals with subtype B and those with an unknown subtype.
Although long-acting cabotegravir and rilpivirine are widely used and effective, limited real-world data are available on how well this treatment works in people with HIV-1 subtype A6. This is important because subtype A6 has been suggested as a potential risk factor for treatment failure, but current evidence is inconclusive.
The study uses existing medical records from treatment centers in Poland, Germany, and the Czech Republic. It includes adults with HIV who have received at least one injection of long-acting cabotegravir and rilpivirine and follows their clinical outcomes for up to 24 months. Researchers will assess viral suppression, treatment persistence, adherence to injection schedules, and reasons for treatment discontinuation.
The results of this study will help clinicians better understand whether HIV-1 subtype A6 affects treatment outcomes and whether knowing a patient's HIV subtype is important when deciding to switch to long-acting injectable therapy. The findings may support safer and more effective use of this treatment in diverse patient populations.
This is a multicentre, international, real-world, retrospective observational study designed to evaluate clinical outcomes of long-acting injectable cabotegravir plus rilpivirine (CAB/RPV LA) in adults living with HIV-1. The study is conducted at HIV treatment centers in Poland, Germany, and the Czech Republic and is based on routinely collected clinical data from electronic medical records and paper charts.
The study population includes treatment-experienced individuals aged 18 years or older who received at least one dose of CAB/RPV LA in routine clinical practice. Participants are grouped according to HIV-1 subtype: subtype A6, subtype B, and unknown subtype. Individuals with known subtype A6 are matched with individuals with subtype B using propensity score matching to reduce the impact of confounding factors. Participants with unknown subtype are analyzed as an unmatched group.
Clinical data are collected from the time of CAB/RPV LA initiation (index date) and from follow-up visits closest to 6, 12, 18, and 24 months after initiation. Outcomes assessed include treatment persistence, adherence to injection schedules, discontinuation rates and reasons for discontinuation, and measures of virologic effectiveness. Virologic outcomes include viral suppression, viral rebound, and confirmed virologic failure as defined by standard HIV RNA criteria.
For participants with unknown HIV-1 subtype, proviral DNA genotyping is performed after initial descriptive analyses to explore whether knowledge of HIV-1 subtype has prognostic relevance for clinical outcomes. Genotypic data are analyzed descriptively and may inform additional exploratory analyses.
As this is a retrospective, non-interventional study using existing clinical data, no study-specific treatment interventions are performed. Safety data collection is limited to adverse events leading to treatment discontinuation, reflecting routine clinical practice. The study aims to provide clinically relevant real-world evidence on the use of CAB/RPV LA across different HIV-1 subtypes, with particular focus on subtype A6.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's planned enrollment of 250 is below the median of 287 across 503 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Pomeranian Medical University Szczecin is the lead sponsor of 69 studies on the registry; 8 are open to participants now.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Lack of patient consent for use of clinical data for research purposes
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort includes adults living with HIV-1 with a confirmed subtype A6 infection who received at least one dose of 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 viral load at treatment initiation. Clinical outcomes, including virologic effectiveness, treatment persistence, adherence, and discontinuation, are assessed retrospectively using existing medical records. This cohort is matched with the subtype B cohort using propensity score methods.
Drug: Cabotegravir Plus Rilpivirine Long-Acting Injectable
This cohort consists of adults living with HIV-1 with a confirmed subtype B infection who received long-acting injectable cabotegravir plus rilpivirine (CAB/RPV LA) in routine clinical practice. Participants are selected and matched to the subtype A6 cohort based on predefined confounding variables, including age, gender, body mass index category, and CD4 cell nadir. Outcomes are evaluated retrospectively to provide a comparative real-world context for the subtype A6 cohort.
Drug: Cabotegravir Plus Rilpivirine Long-Acting Injectable
This cohort includes adults living with HIV-1 who received long-acting injectable cabotegravir plus rilpivirine (CAB/RPV LA) and had no documented HIV-1 subtype at the time of treatment initiation. Participants are analyzed as an unmatched descriptive group. Retrospective clinical outcome data are collected from medical records. For selected participants, proviral DNA genotyping from blood samples is performed after initial analyses to explore the clinical relevance of HIV-1 subtype knowledge prior to switching to long-acting injectable therapy.
Drug: Cabotegravir Plus Rilpivirine Long-Acting Injectable
Cabotegravir plus rilpivirine long-acting (CAB/RPV LA) is a complete antiretroviral regimen administered as intramuscular injections and approved for the maintenance treatment of HIV-1 infection in adults. In this observational, retrospective study, CAB/RPV LA is used as part of routine clinical care and is not assigned by the study protocol. Participants received CAB/RPV LA according to local prescribing information, including dosing intervals and injection windows. The study evaluates real-world clinical outcomes of CAB/RPV LA across different HIV-1 subtype groups (subtype A6, subtype B, and unknown subtype). Outcomes of interest include virologic effectiveness, treatment persistence, adherence to injection schedules, and treatment discontinuation. No study-specific modifications to dosing, administration, or clinical management are performed.
Also known as: CAB/RPV LA, Long-Acting Cabotegravir and Rilpivirine, Cabotegravir + Rilpivirine
Virologic Suppression at Follow-Up
Proportion of participants with HIV-1 RNA viral load \<50 copies/mL at follow-up after initiation of long-acting cabotegravir plus rilpivirine (CAB/RPV LA), assessed using available clinical laboratory measurements. Virologic suppression will be evaluated at approximately 6, 12, 18, and 24 months after treatment initiation, with last observation carried forward where applicable.
Time frame: Up to 24 months after initiation of CAB/RPV LA
Treatment Persistence on CAB/RPV LA
Proportion of participants who remain on long-acting cabotegravir plus rilpivirine (CAB/RPV LA) at each follow-up time point after initiation, based on documentation of continued injections in routine clinical care.
Time frame: Up to 24 months after initiation of CAB/RPV LA
Treatment Discontinuation Rate
Proportion of participants who discontinue CAB/RPV LA after initiation, including documentation of the reason for discontinuation such as adverse events, virologic failure, or other clinical or patient-related reasons.
Time frame: Up to 24 months after initiation of CAB/RPV LA
Time to Treatment Discontinuation
Median time from first administration of CAB/RPV LA to permanent discontinuation of the regimen, calculated using available clinical records.
Time frame: Up to 24 months after initiation of CAB/RPV LA
Adherence to Injection Schedule
Adherence to the CAB/RPV LA dosing schedule, assessed as the proportion of participants receiving injections within the allowed ±7-day dosing window relative to the target injection date.
Time frame: Up to 24 months after initiation of CAB/RPV LA
Delayed or Missed Injections
Proportion of participants with delayed injections (\>7 days after target date), missed injections, and the number and duration of delayed or missed injections during follow-up.
Time frame: Up to 24 months after initiation of CAB/RPV LA
Confirmed Virologic Failure (CVF)
Proportion of participants meeting criteria for confirmed virologic failure, defined as two consecutive HIV-1 RNA measurements ≥200 copies/mL, or one HIV-1 RNA ≥200 copies/mL followed by treatment discontinuation within four months.
Time frame: Up to 24 months after initiation of CAB/RPV LA
Viral Rebound
Proportion of participants experiencing viral rebound, including viral blips (single HIV-1 RNA 50-199 copies/mL followed by \<50 copies/mL), low-level viremia (two consecutive measurements 50-199 copies/mL), or viremia \>200 copies/mL not leading to treatment discontinuation.
Time frame: Up to 24 months after initiation of CAB/RPV LA
Virologic Non-Response After CVF
Proportion of participants who do not achieve re-suppression (HIV-1 RNA \<50 copies/mL) following confirmed virologic failure during the follow-up period.
Time frame: Up to 24 months after initiation of CAB/RPV LA
Plan to share: No — Individual participant data (IPD) will not be shared because this is a retrospective, observational study based on routinely collected clinical data from multiple centers. The data are pseudo-anonymized and subject to local data protection regulations and ethical approvals, which limit the ability to share individual-level data outside the study team.
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Feb 2027, 8 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acquired Immunodeficiency Syndrome →
Pomeranian Medical University Szczecin