Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44343   clinical trials with a EudraCT protocol, of which   7372   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    HIV-1 RNA suppression and drug concentrations in semen, cervicovaginal fluid and rectum in HIV-1 infected individuals receiving intramuscular long-acting cabotegravir plus rilpivirine (“CAR-GR Study)

    Summary
    EudraCT number
    		 2021-006779-41
    Trial protocol
    		 ES  
    Global end of trial date
    05 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jun 2025
    First version publication date
    11 Jun 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAR-GR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Lluita contra les infeccions
    Sponsor organisation address
    Hospital Germans Trias i Pujol S/N Canyet, Badalona, Spain, 08916
    Public contact
    Arkaitz Imaz Vacas, Hospital Universitari de Bellvitge, +34 932607667, aimaz@bellvitgehospital.cat
    Scientific contact
    Arkaitz Imaz Vacas, Hospital Universitari de Bellvitge, +34 932607667, aimaz@bellvitgehospital.cat
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Apr 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Apr 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To determine Cabotegravir and Rilpivirine concentrations in seminal plasma, rectal tissue and cervicovaginal fluid (CVF) in male and female individuals living with HIV receiving IM Cabotegravir and Rilpivirine LA every 2 months.
    Protection of trial subjects
    Investigators provided participants with a comprehensive explanation of the informed consent process and all study-related procedures. Study medication was administered by highly qualified nursing personnel in a controlled, quiet, and private clinical setting to ensure participant comfort and protocol adherence.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    30
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The final recruitment period lasted 9 months. The first subject signed the informed consent in March 2023, and the last one in November 2023.

    Pre-assignment
    Screening details
    		 Inclusion criteria: cisgender adults with HIV-1 on stable ART ≥6 months with virologic suppression. Exclusion: resistance to CAB/RPV, virologic failure to InSTI/NNRTIs, HBV co-infection, pregnancy, severe hepatic/renal issues, grade 4 labs, malignancies, anticoagulants, or bleeding disorders.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Cabotegravir+Rilpivirine
    Arm description
    		 Single Arm, Open-Label
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cabotegravir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Suspension for injection
    Routes of administration
    Intramuscular use, Oral use
    Dosage and administration details
    Cabotegravir Oral use: 30 mg 1 tablet once daily for 28 days. Cabotegravir Intramuscular Use: 600 mg suspension every 2 months.

    Investigational medicinal product name
    Rilpivirine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection, Tablet
    Routes of administration
    Intramuscular use, Oral use
    Dosage and administration details
    Rilpivirine Oral use: 25 mg 1 tablet once daily for 28 days. Rilpivirine Intramuscular Use: 900 mg suspension every 2 months.

    Number of subjects in period 1
    		Cabotegravir+Rilpivirine
    Started
    31
    Completed
    31

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 31 31
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 30 30
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 43 (28 to 66) -
    Gender categorical
    Units: Subjects
        Female
    		 15 15
        Male
    		 16 16

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Cabotegravir+Rilpivirine
    Reporting group description
    		 Single Arm, Open-Label

    Subject analysis set title
    Cisgender Female
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Cisgender Female

    Subject analysis set title
    Cisgender Male Seminal Plasma
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Cisgender Male Seminal Plasma

    Subject analysis set title
    Cisgender Male Rectal Tissue
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Cisgender Male Rectal Tissue

    Primary: Total concentrations of Cabotegravir and Rilpivirine

    		 Close Top of page
    End point title
    		 Total concentrations of Cabotegravir and Rilpivirine [1]
    End point description
    End point type
    Primary
    End point timeframe
    2 months after cabotegravir and rilpivirine LA IM second dose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Quantitative data were summarized as median and range; qualitative data as counts and percentages. Interindividual variability of CAB and RPV in plasma, genital fluids, and rectal tissue was assessed using the coefficient of variation. Correlations were evaluated via Spearman’s rho with bootstrapped confidence intervals. Analyses were conducted using R software (v4.4.1)
    End point values
    		 Cisgender Female Cisgender Male Seminal Plasma Cisgender Male Rectal Tissue
    Number of subjects analysed
    15
    16
    16
    Units: ng/mL
    median (full range (min-max))
        Cabotegravir
    15.63 (0.89 to 428.23)
    23.30 (10.10 to 130.00)
    90.02 (54.35 to 138.77)
        Rilpivirine
    21.41 (0.07 to 47.77)
    2.66 (1.47 to 9.37)
    38.57 (19.68 to 79.64)
    Attachments
    		 Supplementary Material
    No statistical analyses for this end point

    Secondary: Protein unbound fraction of Cabotegravir and Rilpivirine

    		 Close Top of page
    End point title
    		 Protein unbound fraction of Cabotegravir and Rilpivirine
    End point description
    End point type
    Secondary
    End point timeframe
    months after cabotegravir and rilpivirine LA IM second dose
    End point values
    		 Cisgender Female Cisgender Male Seminal Plasma Cisgender Male Rectal Tissue
    Number of subjects analysed
    12
    14
    16
    Units: %
    median (full range (min-max))
        Cabotegravir
    31.86 (12.86 to 50.73)
    56.56 (44.08 to 77.17)
    71.66 (46.04 to 78.44)
        Rilpivirine
    94.92 (46.84 to 97.86)
    97.03 (94.49 to 99.19)
    93.68 (80.27 to 96.86)
    No statistical analyses for this end point

    Secondary: Estimated unbound concentrations of Cabotegravir and Rilpivirine

    		 Close Top of page
    End point title
    		 Estimated unbound concentrations of Cabotegravir and Rilpivirine
    End point description
    End point type
    Secondary
    End point timeframe
    2 months after cabotegravir and rilpivirine LA IM second dose
    End point values
    		 Cisgender Female Cisgender Male Seminal Plasma Cisgender Male Rectal Tissue
    Number of subjects analysed
    12
    14
    16
    Units: ng/mL
    median (full range (min-max))
        Cabotegravir
    13.73 (2.60 to 283.11)
    9.01 (5.20 to 16.43)
    27.10 (13.47 to 59.50)
        Rilpivirine
    0.81 (0.14 to 13.22)
    0.08 (0.04 to 0.19)
    2.69 (1.41 to 5.51)
    No statistical analyses for this end point

    Secondary: HIV-1 RNA

    		 Close Top of page
    End point title
    		 HIV-1 RNA
    End point description
    End point type
    Secondary
    End point timeframe
    2 months after second cabotegravir and rilpivirine LA IM dose
    End point values
    		 Cisgender Female Cisgender Male Seminal Plasma Cisgender Male Rectal Tissue
    Number of subjects analysed
    15
    16
    16
    Units: copies/mL
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are reported from the date of informed consent signature until the subject's last visit in the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Cabotegravir+Rilpivirine
    Reporting group description
    		 Single Arm, Open-Label

    Serious adverse events
    		 Cabotegravir+Rilpivirine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cabotegravir+Rilpivirine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 31 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Angioma surgery
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    General disorders and administration site conditions
    Injection site pain
    Additional description: Likely related to the study treatment
    alternative assessment type: Non-systematic
         subjects affected / exposed
    28 / 31 (90.32%)
         occurrences all number
    53
    Injection site nodule
    Additional description: Likely related to the study treatment
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 31 (12.90%)
         occurrences all number
    4
    Injection site injury
    Additional description: Likely related to the study treatment
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Hematoma injection site
    Additional description: Likely related to the study treatment
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    3
    Asthenia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Caries dental
    Additional description: Dental and oral disorders
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Fainting
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Fever
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    General discomfort
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Injection site discomfort
         subjects affected / exposed
    5 / 31 (16.13%)
         occurrences all number
    6
    Injection site induration
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Odontalgia
    Additional description: Dental and oral disorders
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Periodontitis
    Additional description: Dental and oral disorders
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Reproductive system and breast disorders
    Menstrual flooding
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Vaginal discharge abnormality
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Abscess Bartholin's
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Amenorrhea
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Endocervical polyp
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchitis acute
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Asthmatic attack
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Cold
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    3
    COVID-19
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Pain pharynx
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety disorder aggravated
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Anxiety state
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Nervous system disorders
    Omalgia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    3
    Epicondylitis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Odynophagia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Lymphadenopathy cervical
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Otitis externa
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Gastrointestinal disorders
    Lower abdominal pain
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Fructose intolerance
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Fecal incontinence
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Abnormal stools
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Acute gastritis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Flatus increased
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Heartburn
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hemangioma of liver
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Hepatomegaly
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Transaminitis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Renal and urinary disorders
    Cystitis, unspecified
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Acute lumbago
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    3
    Fasciitis plantar
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Fracture
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Spondyloarthropathy
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Infections and infestations
    Herpes infection
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Axillary abscess
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Chlamydia trachomatis infection of lower genitourinary sites
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Chlamydial proctitis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Condyloma
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Gonorrhoea of anus
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Latent syphilis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Oral gonorrhea
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Papilloma viral infection
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Parasitic infection intestinal
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1
    Scabies
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This study has limitations, including lack of intraindividual variability due to single sampling. Drug levels were assessed 3 months post-switch, before steady state. Still, plasma levels matched expectations from phase 3 trials.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24521854
    http://www.ncbi.nlm.nih.gov/pubmed/28449051
    http://www.ncbi.nlm.nih.gov/pubmed/35986671
    http://www.ncbi.nlm.nih.gov/pubmed/33830459
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Jun 14 23:52:55 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA