Human Immunodeficiency Virus (HIV)-1 InfectionLACRISNCT07370649
Long-Acting Cabotegravir and Rilpivirine in People Living With HIV-1 Subtype A6: A Real-World Retrospective Study
An observational study of Human Immunodeficiency Virus (HIV)-1 Infection and HIV-1 Subtype A6 Infection, run by Pomeranian Medical University Szczecin at 7 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus (HIV)-1 Infection, HIV-1 Subtype A6 Infection, HIV-1 Subtype B Infection
- What is being tested?
- Cabotegravir Plus Rilpivirine Long-Acting Injectable
- Type of treatment
- Injection or infusion
- How many people
- 250 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 12 May 2026to Mar 2027
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- Lack of patient consent for use of clinical data for research purposes
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Karolina Sorbian-Gajewska contact
7 sites in 3 countries
Poland5 sites, 5 recruiting
- Recruiting
Wojewódzki Szpital Obserwacyjno-Zakaźny
Bydgoszcz
Anita Olczak, dr hab. n. med., sekretariat@wsoz.pl
Anita Olczak, dr hab. n. med.
- Recruiting
Szpitale Pomorskie
Gdansk
Maria Hlebowicz, Dr n.med.
Maria Hlebowicz, dr n. med.
- Not yet recruiting
Katedra Chorób Zakaźnych i Niedoborów Immunologicznych
Szczecin, West Pomeranian Voivodeship, 71-455
Miłosz Parczewski, prof. dr hab. n. med., +48 91 813 94 41, klinzak@pum.edu.pl
- Recruiting
Wojewódzki Szpital Zakaźny w Warszawie
Warsaw
Iwona Cielniak, dr n. med., 22 335 53 51, sekretariat@zakazny.pl
Iwona Cielniak, dr n. med.
- Recruiting
Wrocławskie Centrum Zdrowia
Wroclaw
Aleksandra Szymczyk, dr n. med., 71 326 67 30, metadon@spzoz.wroc.pl
Aleksandra Szymczak, dr n. med.
Czechia1 site, 1 recruiting
- Recruiting
Hospital Na Bulovce Praque HIV Centre, Department of Infectious Diseases
Prague
David Jilich, +420 26608 2629, hiv@bulovka.cz
David Jilich, MD
Germany1 site, 1 recruiting
- Recruiting
MainFachArzt
Frankfurt
Pavel Khaykin, MD, +49 69 253103, praxis@mainfacharzt.de
Pavel Khaykin, MD
About this study
Official title: Long-Acting Cabotegravir And Rilipivirine In People Living With HIV-1 Subtype A6. A Multicentre Real-world, Retrospective Matched Case Study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Human Immunodeficiency Virus (HIV)-1 Infection, HIV-1 Subtype A6 Infection, HIV-1 Subtype B Infection, Virologically Suppressed HIV-1 Infection Receiving Long-Acting Antiretroviral Therapy
- Being tested
- Cabotegravir Plus Rilpivirine Long-Acting Injectable
- Keywords
- HIV-1, Long-Acting Antiretroviral Therapy, Cabotegravir, Rilpivirine, CAB/RPV LA, HIV-1 Subtype A6, HIV-1 Subtype B, Virologic Suppression, Real-World Study, Retrospective Study, Injectable HIV Therapy, Treatment Persistence, Virologic Failure
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabotegravir Plus Rilpivirine Long-Acting InjectableDrug
Also called CAB/RPV LA, Long-Acting Cabotegravir and Rilpivirine, Cabotegravir + Rilpivirine
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.
| Study group | Role | What they receive |
|---|---|---|
| HIV-1 subtype A6 | 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. Receives: Drug: Cabotegravir Plus Rilpivirine Long-Acting Injectable | |
| HIV-1 Subtype B Cohort | 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. Receives: Drug: Cabotegravir Plus Rilpivirine Long-Acting Injectable | |
| HIV-1 Subtype Unknown Cohort | 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. Receives: Drug: Cabotegravir Plus Rilpivirine Long-Acting Injectable |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 months after initiation of CAB/RPV LA
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 months after initiation of CAB/RPV LA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start12 May 2026
- Primary completion1 Feb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)-1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370649
- Sponsor's protocol ID
- LACRIS
- Acronym
- LACRIS
- Status last verified
- Jun 2026
- First submitted
- 19 Jan 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Acting Cabotegravir And Rilipivirine In People Living With HIV-1 Subtype A6. A Multicentre Real-world, Retrospective Matched Case Study
- ClinicalTrials.gov ID
- NCT07370649
- Acronym / sponsor ID
- LACRIS / LACRIS
- Conditions
- Human Immunodeficiency Virus (HIV)-1 Infection, HIV-1 Subtype A6 Infection, HIV-1 Subtype B Infection, Virologically Suppressed HIV-1 Infection Receiving Long-Acting Antiretroviral Therapy
- Keywords
- HIV-1, Long-Acting Antiretroviral Therapy, Cabotegravir, Rilpivirine, CAB/RPV LA, HIV-1 Subtype A6, HIV-1 Subtype B, Virologic Suppression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 12 May 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 24 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV-1 subtype A6 | – | Drug: Cabotegravir Plus Rilpivirine Long-Acting InjectableThis 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. |
| HIV-1 Subtype B Cohort | – | Drug: Cabotegravir Plus Rilpivirine Long-Acting InjectableThis 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. |
| HIV-1 Subtype Unknown Cohort | – | Drug: Cabotegravir Plus Rilpivirine Long-Acting InjectableThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Lack of patient consent for use of clinical data for research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabotegravir Plus Rilpivirine Long-Acting InjectableAlso: CAB/RPV LA, Long-Acting Cabotegravir and Rilpivirine, Cabotegravir + RilpivirineCabotegravir 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. | Drug | HIV-1 Subtype B Cohort, HIV-1 Subtype Unknown Cohort, HIV-1 subtype A6 |
Primary outcome
Virologic Suppression at Follow-Up
Time frame: Up to 24 months after initiation of CAB/RPV LA
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.
8 secondary outcomes
Treatment Persistence on CAB/RPV LA
Time frame: Up to 24 months after initiation of CAB/RPV LA
Treatment Discontinuation Rate
Time frame: Up to 24 months after initiation of CAB/RPV LA
Time to Treatment Discontinuation
Time frame: Up to 24 months after initiation of CAB/RPV LA
Adherence to Injection Schedule
Time frame: Up to 24 months after initiation of CAB/RPV LA
Delayed or Missed Injections
Time frame: Up to 24 months after initiation of CAB/RPV LA
Confirmed Virologic Failure (CVF)
Time frame: Up to 24 months after initiation of CAB/RPV LA
Viral Rebound
Time frame: Up to 24 months after initiation of CAB/RPV LA
Virologic Non-Response After CVF
Time frame: Up to 24 months after initiation of CAB/RPV LA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karolina Sorbian-Gajewska contact
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus (HIV)-1 Infection and HIV-1 Subtype A6 Infection, run by Pomeranian Medical University Szczecin at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Poland, Czechia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miłosz Parczewski, prof. dr hab. n. med. (+48 91 813 94 41, klinzak@pum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virologic Suppression at Follow-Up (time frame: Up to 24 months after initiation of CAB/RPV LA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.