Clinical trial • Phase III • Infectious Disease
CABOTEGRAVIR for HIV-1 infection
Phase III trial of CABOTEGRAVIR for HIV-1 infection.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- HIV-1 infection
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 03-10-2024
- First CTIS Authorization Date
- 18-12-2024
Trial design
Randomised, open-label, active intervention: cab + rpv la (cabotegravir + rilpivirine long-acting intramuscular injections; initiation injections on day 1 and month 1 then maintenance injections every 2 months through month 23). comparator arm: standard-of-care oral art (participants remain on their current oral art up to month 6; participants with viral load <50 c/ml at month 6 may have the option to switch to cab + rpv la with initiation injections ~1 week after month 6 and month 7, then maintenance every 2 months). specific injection product doses in protocol: vocabria (cabotegravir) 600 mg im and rekambys (rilpivirine) 900 mg im prolonged-release injections.-controlled Phase III trial in Spain, Germany, Belgium and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Active intervention: CAB + RPV LA (cabotegravir + rilpivirine long-acting intramuscular injections; initiation injections on Day 1 and Month 1 then maintenance injections every 2 months through Month 23). Comparator arm: Standard-of-care oral ART (participants remain on their current oral ART up to Month 6; participants with viral load <50 c/mL at Month 6 may have the option to switch to CAB + RPV LA with initiation injections ~1 week after Month 6 and Month 7, then maintenance every 2 months). Specific injection product doses in protocol: Vocabria (cabotegravir) 600 mg IM and REKAMBYS (rilpivirine) 900 mg IM prolonged-release injections.
- Target Sample Size
- 234
- Trial Duration For Participant
- 730
Eligibility
Recruits 234 paediatric patients.
- Pregnancy Exclusion
- Participants who are pregnant, breast/chest feeding or plan to become pregnant or breast/chest feed during the study
- Vulnerable Population
- Adolescents are included (minimum age 12). Consent must be given by the participant if aged 18+ or by a participant's parent/legal guardian for minors; where applicable adolescent participants must assent. Adolescents who are wards of the state are explicitly excluded.
Inclusion criteria
- {"criterion_text":"- Aged at least 12 years old and weighting at least 35 kg\n- Documented HIV-1 infection with plasma HIV-1 RNA >1,000 and <100,000 c/mL\n- Evidence of insufficient virologic response to participant's current oral ART regimen (defined as participant having an active prescription) within 18 months before study entry according to at least 1 of the following criteria: i.\t<1 log10 decrease in HIV-1 RNA or HIV-1 RNA >200 c/mL at 2 time points at least 4 weeks apart in individuals who have been prescribed oral ART for at least 3 consecutive months. ii.\tDocumented lapse in current oral ART regimen usage expected to result in HIV-1 viremia (defined as at least a 30-day consecutive period of non-use of oral ART) iii.\tDocumented need for change from oral ART regimen that investigator attributes as primary reason for insufficient virologic response (e.g., safety findings and/or limited tolerability, clinically relevant DDIs)\n- Currently being treated with/prescribed an oral ART regimen and willing to continue taking an oral ART regimen until after their Month 6 viral load result is available.\n- Participant (if aged 18+) or a participant's parent/legal guardian is able to give signed informed consent. Where applicable an adolescent participant is able to assent to participate in the study.\n- Staff study participants are eligible to participate if they are responsible for/involved in adherence support for CAB + RPV LA, are able to agree to and have the time to participate in interviews and questionnaire completion, and have the cognitive ability to complete questionnaires and take part in an interview that may take up to 60 minutes."}
Exclusion criteria
- {"criterion_text":"- HIV-1 subtype A6\n- Any previous use of CAB\n- Current or recent use of medications prohibited or defined as exclusionary in the protocol.\n- Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study medication.\n- Current or anticipated participation in another interventional study.\n- Evidence of viral drug resistance to INSTIs or NNRTIs at Screening or in any historical resistance test result.\n- Has exclusionary safety laboratory test results at Screening\n- QTc >450 msec or >480 msec for participants with bundle branch block at Screening\n- Unwilling to receive injections or unable to receive gluteal injections.\n- Participant has gluteal implants or prosthesis; or a tattoo or other dermatological condition in the gluteus region which may interfere with interpretation of injection site reactions.\n- Evidence of alcohol or substance use disorder within the previous 12 months, as assessed by the Investigator using standard methods for their site, that would interfere with the participant's safety.\n- Participants who are pregnant, breast/chest feeding or plan to become pregnant or breast/chest feed during the study\n- Adolescents who are wards of the state.\n- Staff study participants will be excluded if they are not involved in adherence support for viremic patients on CAB + RPV LA or if they are unwilling to be audio recorded during the interviews.\n- Unstable liver disease or a history of liver cirrhosis with or without hepatitis viral co-infection.\n- Co-infection with Hepatitis B where they would not be able to receive appropriate therapy for their HBV co-infection or with Hepatitis C if they are currently receiving anti-HCV therapy at Day 1\n- Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.\n- Participants with a high risk of seizures, including those with an unstable or poorly controlled seizure disorder.\n- High sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that contraindicates their participation.\n- Participants who pose a significant suicidality risk. History of suicidal behavior and/or suicidal ideation should be considered when assessing suicide risk.\n- Pre-existing physical or mental condition that may interfere with the participant's ability to comply with the dosing schedule and/or protocol assessments, or which may compromise participant safety."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Virologic response (HIV 1 RNA <50 c/mL) using the Snapshot Algorithm at Month 6","definition_or_measurement_approach":"Virologic response defined as HIV-1 RNA <50 c/mL measured at Month 6 using the Snapshot Algorithm"}
Secondary endpoints
- {"endpoint_text":"- Time to virologic suppression (HIV-1 RNA <50 c/mL) from baseline (Day 1) through Month 6","definition_or_measurement_approach":"Time from baseline (Day 1) to first visit with HIV-1 RNA <50 c/mL up to Month 6"}
- {"endpoint_text":"- Time to TRDF (PDVF or drug-related AE, intolerability of injections, protocol defined stopping criteria or lack of efficacy) from baseline (Day 1) through Month 6","definition_or_measurement_approach":"Time from baseline (Day 1) to Treatment Related Discontinuation/Failure (PDVF or drug-related AE, injection intolerability, protocol stopping criteria or lack of efficacy) up to Month 6"}
- {"endpoint_text":"- Protocol-defined VF through Month 6","definition_or_measurement_approach":"Occurrence of protocol-defined virologic failure through Month 6"}
- {"endpoint_text":"- Occurrence of developing RAMs through Month 6","definition_or_measurement_approach":"Incidence of treatment-emergent resistance-associated mutations (RAMs) through Month 6"}
- {"endpoint_text":"- Occurrence of developing INSTI or NNRTI RAMs through Months 12 and 24","definition_or_measurement_approach":"Incidence of developing INSTI or NNRTI resistance-associated mutations assessed at Months 12 and 24"}
Recruitment
- Planned Sample Size
- 234
- Recruitment Window Months
- 36
- Consent Approach
- Informed consent is required from the participant if aged 18+ or from a parent/legal guardian for minors. Adolescent participants (from age 12) must provide assent where applicable. Pediatric assent forms are provided (documents referencing Pediatric/Paediatric Assent; specific assent forms for ages 12-15 and 12-17 are listed). Multiple language versions of ICFs and assent forms are available (English, Spanish, Portuguese, German, Italian and country-specific versions for Belgium/France/Netherlands as indicated by document listings).
Methods
- Use of third-party patient recruitment and retention vendor (Matthews Media Group Inc.) as listed in sponsor third parties (role: Patient Recruitment and Retention).
- Use of recruitment and retention materials (K2 brochures, posters, flyers, patient letters, optional contact forms, visit calendars) for site-based recruitment (documents listed under recruitment arrangements).
- Site-based recruitment via participating hospitals/infectious disease clinics at listed trial sites in each country.
- Patient payments/stipends and reimbursements managed via third parties (Greenphire LLC listed with role Patient Payments/Stipends; Sermes CRO and ZALARIS have roles for fee reimbursement and patient fee reimbursement).
Geography
- Total Number Of Sites
- 34
- Total Number Of Participants
- 98
Spain
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 18-12-2025
- Processing Time Days
- 507
- Number Of Sites
- 21
- Number Of Participants
- 71
Sites
- Site Name
- Bellvitge University Hospital
- Department Name
- Servicio de Infecciosas
- Principal Investigator Name
- Maria Saumoy Linares
- Principal Investigator Email
- msaumoy@bellvitgehospital.cat
- Contact Person Name
- Maria Saumoy Linares
- Contact Person Email
- msaumoy@bellvitgehospital.cat
- Site Name
- Hospital Del Mar
- Department Name
- Servicio de Infecciosas
- Principal Investigator Name
- Roberto Güerri - Fernández
- Principal Investigator Email
- rguerri@psmar.cat
- Contact Person Name
- Roberto Güerri - Fernández
- Contact Person Email
- rguerri@psmar.cat
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Manuel Castaño Carracedo
- Principal Investigator Email
- med000849@gmail.com
- Contact Person Name
- Manuel Castaño Carracedo
- Contact Person Email
- med000849@gmail.com
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Servicio de Infecciosas
- Principal Investigator Name
- Vicente Estrada Pérez
- Principal Investigator Email
- vicente.estrada@salud.madrid.org
- Contact Person Name
- Vicente Estrada Pérez
- Contact Person Email
- vicente.estrada@salud.madrid.org
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Servicio de Infecciosas
- Principal Investigator Name
- Ignacio Santos Gil
- Principal Investigator Email
- isantosg@salud.madrid.org
- Contact Person Name
- Ignacio Santos Gil
- Contact Person Email
- isantosg@salud.madrid.org
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Infecciosas
- Principal Investigator Name
- Paula Suanzes Diez
- Principal Investigator Email
- paula.suanzes@vallhebron.cat
- Contact Person Name
- Paula Suanzes Diez
- Contact Person Email
- paula.suanzes@vallhebron.cat
- Site Name
- Hospital Universitario De Puerto Real
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Alberto Romero Palacios
- Principal Investigator Email
- albertoromeropalacios@gmail.com
- Contact Person Name
- Alberto Romero Palacios
- Contact Person Email
- albertoromeropalacios@gmail.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Servicio de Microbiología Clínica y enfermedades Infecciosas
- Principal Investigator Name
- Cristina Díez Romero
- Principal Investigator Email
- crispu82@gmail.com
- Contact Person Name
- Cristina Díez Romero
- Contact Person Email
- crispu82@gmail.com
- Site Name
- University Hospital Son Espases
- Department Name
- Servicio de Infecciosas
- Principal Investigator Name
- Luisa Martín Pena
- Principal Investigator Email
- marial.martin@ssib.es
- Contact Person Name
- Luisa Martín Pena
- Contact Person Email
- marial.martin@ssib.es
- Site Name
- Hospital Clinico Universitario Lozano Blesa
- Department Name
- Servicio de Infecciosas
- Principal Investigator Name
- Maria Jose Crussels Canales
- Principal Investigator Email
- pcrusells@gmail.com
- Contact Person Name
- Maria Jose Crussels Canales
- Contact Person Email
- pcrusells@gmail.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Servicio de medicina interna
- Principal Investigator Name
- Carlos Galera Peñaranda
- Principal Investigator Email
- carlosgalerap@gmail.com
- Contact Person Name
- Carlos Galera Peñaranda
- Contact Person Email
- carlosgalerap@gmail.com
- Site Name
- Hospital Universitario Infanta Leonor
- Department Name
- Servicio de Medicina Interna
- Principal Investigator Name
- Guillermo Cuevas Tascón
- Principal Investigator Email
- guillermocuevastascon@gmail.com
- Contact Person Name
- Guillermo Cuevas Tascón
- Contact Person Email
- guillermocuevastascon@gmail.com
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Servicio de enfermedades infecciosas
- Principal Investigator Name
- Marta Navarro Vilasaró
- Principal Investigator Email
- mnavarro@tauli.cat
- Contact Person Name
- Marta Navarro Vilasaró
- Contact Person Email
- mnavarro@tauli.cat
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Servicio de enfermedades Infecciosas
- Principal Investigator Name
- Antonio Rivero Román
- Principal Investigator Email
- ariveror@gmail.com
- Contact Person Name
- Antonio Rivero Román
- Contact Person Email
- ariveror@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de Medicina Interna
- Principal Investigator Name
- María de Lagarde Sebastián
- Principal Investigator Email
- estudioshiv12@gmail.com
- Contact Person Name
- María de Lagarde Sebastián
- Contact Person Email
- estudioshiv12@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Servicio de Infecciosas
- Principal Investigator Name
- Mª Jesús Pérez Elías
- Principal Investigator Email
- mjperez90@gmail.com
- Contact Person Name
- Mª Jesús Pérez Elías
- Contact Person Email
- mjperez90@gmail.com
- Site Name
- Hospital Alvaro Cunqueiro
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Alexandre Pérez González
- Principal Investigator Email
- alexandre.perez@iisgaliciasur.es
- Contact Person Name
- Alexandre Pérez González
- Contact Person Email
- alexandre.perez@iisgaliciasur.es
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Servicio de Infecciosas, Microbiología Clínica y Medicina Preventiva
- Principal Investigator Name
- Rosario Palacios Muñoz
- Principal Investigator Email
- mariar.palacios.sspa@juntadeandalucia.es
- Contact Person Name
- Rosario Palacios Muñoz
- Contact Person Email
- mariar.palacios.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Basurto
- Department Name
- Servicio de enfermedades infecciosas
- Principal Investigator Name
- Sofía Ibarra Ugarte
- Principal Investigator Email
- SOFIA.IBARRAUGARTE@osakidetza.eus
- Contact Person Name
- Sofía Ibarra Ugarte
- Contact Person Email
- SOFIA.IBARRAUGARTE@osakidetza.eus
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Unitat de VIH-SIDA
- Principal Investigator Name
- Josep Mallolas Masferrer
- Principal Investigator Email
- mallolas@clinic.cat
- Contact Person Name
- Josep Mallolas Masferrer
- Contact Person Email
- mallolas@clinic.cat
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Servicio de Infecciosas
- Principal Investigator Name
- Miguel Górgolas Hernández-Mora
- Principal Investigator Email
- mgorgolas@fjd.es
- Contact Person Name
- Miguel Górgolas Hernández-Mora
- Contact Person Email
- mgorgolas@fjd.es
Germany
- Earliest CTIS Part Ii Submission Date
- 05-08-2025
- Latest Decision Or Authorization Date
- 18-12-2025
- Processing Time Days
- 135
- Number Of Sites
- 5
- Number Of Participants
- 8
Sites
- Site Name
- zibp Zentrum fuer Infektiologie Berlin Prenzlauer Berg GmbH
- Principal Investigator Name
- Stephan Grunwald
- Principal Investigator Email
- grunwald@zfi-berlin.de
- Contact Person Name
- Stephan Grunwald
- Contact Person Email
- grunwald@zfi-berlin.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Klinik für Gastroenterologie, Hepatologie und Infektiologie
- Principal Investigator Name
- Björn-Erik Ole Jensen
- Principal Investigator Email
- bjoern-ErikOle.Jensen@med.uni-duesseldorf.de
- Contact Person Name
- Björn-Erik Ole Jensen
- Contact Person Email
- bjoern-ErikOle.Jensen@med.uni-duesseldorf.de
- Site Name
- Dr. Scholten & Schneeweiß GbR
- Principal Investigator Name
- Stefan Scholten
- Principal Investigator Email
- Stefan.Scholten@praxis-hohenstaufenring.de
- Contact Person Name
- Stefan Scholten
- Contact Person Email
- Stefan.Scholten@praxis-hohenstaufenring.de
- Site Name
- Praxis am Ebertplatz
- Principal Investigator Name
- Christoph Wyen
- Principal Investigator Email
- wyen@praxis-ebertplatz.de
- Contact Person Name
- Christoph Wyen
- Contact Person Email
- wyen@praxis-ebertplatz.de
- Site Name
- Infektio Research GmbH & Co. KG
- Principal Investigator Name
- Thomas Lutz
- Principal Investigator Email
- lutz@infektio-research.de
- Contact Person Name
- Thomas Lutz
- Contact Person Email
- lutz@infektio-research.de
Belgium
- Earliest CTIS Part Ii Submission Date
- 12-09-2025
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 173
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Institute Of Tropical Medicine
- Department Name
- HIV/STI Clinic
- Principal Investigator Name
- Chris Kenyon
- Principal Investigator Email
- ckenyon@itg.be
- Contact Person Name
- Chris Kenyon
- Contact Person Email
- ckenyon@itg.be
Italy
- Earliest CTIS Part Ii Submission Date
- 24-06-2025
- Latest Decision Or Authorization Date
- 18-12-2025
- Processing Time Days
- 177
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- UO Malattie Infettive
- Principal Investigator Name
- Antonella Castagna
- Principal Investigator Email
- castagna.antonella1@hsr.it
- Contact Person Name
- Antonella Castagna
- Contact Person Email
- castagna.antonella1@hsr.it
- Site Name
- National Institute For Infectious Diseases Lazzaro Spallanzani
- Department Name
- UOC Immunodeficienze Virali
- Principal Investigator Name
- Andrea Antinori
- Principal Investigator Email
- andrea.antinori@inmi.it
- Contact Person Name
- Andrea Antinori
- Contact Person Email
- andrea.antinori@inmi.it
- Site Name
- Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
- Department Name
- UO Malattie Infettive
- Principal Investigator Name
- Annalisa Saracino
- Principal Investigator Email
- annalisa.saracino@uniba.it
- Contact Person Name
- Annalisa Saracino
- Contact Person Email
- annalisa.saracino@uniba.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- SC Malattie Infettive
- Principal Investigator Name
- Diego Ripamonti
- Principal Investigator Email
- dripamonti@asst-pg23.it
- Contact Person Name
- Diego Ripamonti
- Contact Person Email
- dripamonti@asst-pg23.it
- Site Name
- Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
- Department Name
- S.C. Malattie Infettive e Tropicali
- Principal Investigator Name
- Giulia Carla Marchetti
- Principal Investigator Email
- giulia.marchetti@unimi.it
- Contact Person Name
- Giulia Carla Marchetti
- Contact Person Email
- giulia.marchetti@unimi.it
Portugal
- Earliest CTIS Part Ii Submission Date
- 24-06-2025
- Latest Decision Or Authorization Date
- 09-01-2026
- Processing Time Days
- 199
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Unidade Local de Saude de Sao Joao E.P.E.
- Department Name
- Infectiology Department
- Principal Investigator Name
- Rosário Serrão
- Principal Investigator Email
- rosarioserrao@chsj.min-saude.pt
- Contact Person Name
- Rosário Serrão
- Contact Person Email
- rosarioserrao@chsj.min-saude.pt
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Department Name
- Infectiology Department
- Principal Investigator Name
- Josefina Mendez
- Principal Investigator Email
- u23231@chporto.min-saude.pt
- Contact Person Name
- Josefina Mendez
- Contact Person Email
- u23231@chporto.min-saude.pt
Sponsor
Primary sponsor
- Full Name
- Viiv Healthcare UK Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Contract research organisations
- Name
- Iqvia Inc.
- Responsibilities
- code 7
- Name
- PPD Global Central Labs
- Responsibilities
- code 4
- Name
- Sermes CRO
- Responsibilities
- patient fee reimbursement
- Name
- Labcorp Early Development Laboratories Inc.
- Responsibilities
- code 4
- Name
- Pharma Bio-Research Group
- Responsibilities
- code 4
Third parties
- {"country":"United States","full_name":"Monogram Biosciences Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"IL-CSM Clinical Supplies Management GmbH","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Matthews Media Group Inc.","duties_or_roles":"Patient Recruitment and Retention","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Pharma Bio-Research Group","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"medicine product destruction","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"ZALARIS Deutschland GmbH","duties_or_roles":"patient fee reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Recruitment and Retention Materials","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Payments/Stipends","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"code 7","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"patient fee reimbursement","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Vocabria 600 mg prolonged-release suspension for injection
- Active Substance
- CABOTEGRAVIR
- Modality
- Small molecule
- Routes Of Administration
- INTRAMUSCULAR USE
- Route
- Intramuscular
- Authorisation Status
- Marketing authorisation (EU/1/20/1481/003)
- Starting Dose
- 600 mg
- Dose Levels
- 600 mg
- Frequency
- Initiation injections on Day 1 and Month 1 then maintenance injections every 2 months through Month 23
- Maximum Dose
- 7800 mg
- Investigational Product Name
- REKAMBYS 900 mg prolonged-release suspension for injection
- Active Substance
- RILPIVIRINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAMUSCULAR USE
- Route
- Intramuscular
- Authorisation Status
- Marketing authorisation (EU/1/20/1482/002)
- Starting Dose
- 900 mg
- Dose Levels
- 900 mg
- Frequency
- Initiation injections on Day 1 and Month 1 then maintenance injections every 2 months through Month 23
- Maximum Dose
- 11700 mg
- Combination Treatment
- Yes
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