Cabotegravir sodium for HIV infection

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years."}
• {"criterion_text":"- Cisgender men who have sex with men."}
• {"criterion_text":"- Have taken oral TDF/FTC based PrEP during the past 6 months, either daily or on-demand, with a documented PrEP prescription."}
• {"criterion_text":"- Person affiliated with or a beneficiary of a social security scheme (article L1121-11 of the Public Health Code)."}
• {"criterion_text":"- Informed and written consent, signed by the person and the investigator on the day of inclusion, at the latest, and before any examination carried out within the setting of the study (article L1122-1-1 of the Public Health Code)."}

Exclusion criteria

• {"criterion_text":"-\tPositive HIV test result at screening or enrollment visit, even if HIV infection is not confirmed."}
• {"criterion_text":"-\tSymptoms and/or clinical signs consistent with an acute HIV infection."}
• {"criterion_text":"-\tHistory of seizure disorder."}
• {"criterion_text":"-\tOngoing Post-Exposure Prophylaxis (PEP) for HIV."}
• {"criterion_text":"-\tLast titer of hepatitis B surface antibody (anti-HBs) < 10 mIU/mL."}
• {"criterion_text":"-\tConcomitant use of antimycobacterial (rifampin, rifapentine) or enzyme-inducing anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin, etc.)."}
• {"criterion_text":"-\tParticipants with severe hepatic impairment (Class C) as determined by Child-Pugh classification."}
• {"criterion_text":"-\tParticipants having a non-treated chronic HCV infection."}
• {"criterion_text":"-\tCurrent or chronic history of liver disease or known hepatic or biliary abnormalities."}
• {"criterion_text":"-\tAspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 5-fold the upper normal limit (UNL)."}
• {"criterion_text":"-\tCreatinine clearance lower than 50 mL/min."}
• {"criterion_text":"-\tHistory of chronic renal disease, osteoporosis or osteopenia."}
• {"criterion_text":"-\tInflammatory skin conditions which compromise the safety of intramuscular (IM) injections."}
• {"criterion_text":"-\tKnown thrombocytopenia or any other known bleeding disorder, which would contraindicate IM injection."}
• {"criterion_text":"-\tTreatment with oral anticoagulant (antiplatelet agents are allowed)."}
• {"criterion_text":"-\tKnown or suspected allergy to study product components."}
• {"criterion_text":"-\tSurgically placed buttock implants."}
• {"criterion_text":"-\tPlanned trip abroad of more than 2 consecutive months or planned move outside the Ile de France region."}
• {"criterion_text":"-\tIndividuals who, upon the investigator’s judgement, will not be likely to comply the clinical trial procedures, or with any condition incompatible with study participation."}
• {"criterion_text":"-\tPerson participating in another research study with an exclusion period still in progress at inclusion."}
• {"criterion_text":"-\tPerson under guardianship or curatorship or deprived of liberty by judicial or administrative decision."}

Primary endpoints

• {"endpoint_text":"- Completion of all protocol visits at Month 12 with a documented PrEP prescription of CAB or TDF/FTC at each study aligned with the randomization arm.","definition_or_measurement_approach":"Measured as having completed all protocol visits through Month 12 and having a documented PrEP prescription (CAB or TDF/FTC) at each visit aligned with the randomized arm (documentation captured in study records/eCRF)."}

Secondary endpoints

• {"endpoint_text":"- Completion of all protocol visits at Month 24 with a documented PrEP prescription of CAB or TDF/FTC at each study aligned with the randomization arm","definition_or_measurement_approach":"Measured as completion of protocol visits through Month 24 and documented PrEP prescription at each visit (captured in eCRF)."}
• {"endpoint_text":"- Causes of non-sustained PrEP use over time: missing follow-up visits defined by a visit occurring more than 15 days after the scheduled date, temporary PrEP discontinuation, permanent PrEP discontinuation, switching to another PrEP regimen different from the randomization arm, study discontinuation with PrEP cessation, study discontinuation while maintaining PrEP, and lost to follow-up.","definition_or_measurement_approach":"Categorization of reasons for non-sustained PrEP use based on visit timing (>15 days late), treatment discontinuation types, regimen switches, study discontinuation status, and loss to follow-up as recorded in study data."}
• {"endpoint_text":"- PrEP coverage of the last condomless anal sexual intercourse based on self-report at each study visits. This information will be collected in the study eCRF.","definition_or_measurement_approach":"Self-reported coverage of last condomless anal intercourse collected at study visits and entered into eCRF."}
• {"endpoint_text":"- Satisfaction regarding PrEP regimen measured by a self-administered questionnaire at baseline, 12 and 24 months","definition_or_measurement_approach":"Participant-reported satisfaction via self-administered questionnaire at baseline, Month 12 and Month 24."}
• {"endpoint_text":"- Number of sexual partners in the last 3 months evaluated by a self-administered questionnaire before the visits at baseline, 6, 12, 18 and 24 months.","definition_or_measurement_approach":"Self-administered questionnaire reporting number of sexual partners in prior 3 months at scheduled visits."}
• {"endpoint_text":"- Number of condomless anal sexual intercourse in the month prior each study visits. This information will be collected in the study eCRF.","definition_or_measurement_approach":"Count of condomless anal intercourse in the month prior to each visit collected in eCRF."}
• {"endpoint_text":"- Occurrence of syphilis, chlamydia, and gonorrhea infections at any time during the study.","definition_or_measurement_approach":"Documented diagnoses of syphilis, chlamydia, or gonorrhea during study follow-up as recorded in study records."}
• {"endpoint_text":"- Weight, blood pressure, fasting lipid level and HOMA index measured at baseline, 12, and 24 months.","definition_or_measurement_approach":"Objective measurements of weight, blood pressure, fasting lipids and HOMA index at specified visits."}
• {"endpoint_text":"- Occurrence of Grade 2 or higher clinical or laboratory drug-related adverse events at any time during the study.","definition_or_measurement_approach":"Recording of drug-related adverse events graded ≥ Grade 2 (clinical or laboratory) during study period."}
• {"endpoint_text":"- Injection site reaction and its severity evaluated by the investigator at each injection visits.","definition_or_measurement_approach":"Investigator assessment of injection site reactions and severity at injection visits."}
• {"endpoint_text":"- Perception of pain and injection site reactions by participants measured through a self-administrated questionnaire at baseline, 6, 12, 18 and 24 months.","definition_or_measurement_approach":"Participant-reported pain and injection site reactions collected via self-administered questionnaires at specified visits."}
• {"endpoint_text":"- PrEP regimen used in the month prior to each study visits (TDF/FTC: daily or on-demand, CAB group: CAB oral or CAB-LA). This information will be collected in the study eCRF.","definition_or_measurement_approach":"Recording of regimen used in prior month (daily or on-demand TDF/FTC; CAB oral or CAB-LA) in eCRF."}
• {"endpoint_text":"- Concentration of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) in dried blood spots (DBS) at baseline.","definition_or_measurement_approach":"Laboratory measurement of TFV-DP and FTC-TP concentrations in DBS at baseline."}
• {"endpoint_text":"- Drugs concentrations in plasma measured at Months 6, 12, 18 and 24: o\tCAB Group: cabotegravir concentration in plasma. o\tTDF/FTC group: tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) concentration in dried blood spots (DBS).","definition_or_measurement_approach":"Assays of cabotegravir in plasma for CAB group and TFV-DP/FTC-TP in DBS for TDF/FTC group at Months 6,12,18,24."}
• {"endpoint_text":"- Study visits occurring “on-time” (At Month 1: ±3 days, other visits: ±7 days).","definition_or_measurement_approach":"Assessment of visit timing relative to windows: Month 1 ±3 days; other visits ±7 days."}
• {"endpoint_text":"- Occurrence of HIV infection at any time during the study, defined as a positive HIV antibody immunoassay (4th generation) confirmed by the presence of HIV ribonucleic acid (RNA).","definition_or_measurement_approach":"HIV infection defined by positive 4th generation antibody assay confirmed by detectable HIV RNA in separate samples."}
• {"endpoint_text":"- HIV drug resistance mutations among HIV-infected participants.","definition_or_measurement_approach":"Genotypic assessment for antiretroviral resistance mutations in participants who acquire HIV during study."}
• {"endpoint_text":"- Use of psychoactive drugs in the last 3 months evaluated by a self-administered questionnaire before the visits at baseline, 6, 12, 18 and 24 months.","definition_or_measurement_approach":"Participant-reported psychoactive drug use in prior 3 months via self-administered questionnaires."}
• {"endpoint_text":"- Quality of life measured by the EuroQol-5D questionnaire at baseline, 12 and 24 months.","definition_or_measurement_approach":"EQ-5D questionnaire administered at baseline, Month 12 and Month 24 to assess quality of life."}
• {"endpoint_text":"- Mental health measured by the Center for Epidemiologic Studies Depression Scale and the Rosenberg self-esteem scale at baseline, 12 and 24 months.","definition_or_measurement_approach":"Administration of CES-D and Rosenberg self-esteem scales at baseline, Month 12 and Month 24."}
• {"endpoint_text":"- PrEP knowledge score evaluated by a self-administered questionnaire at baseline, 12 and 24 months.","definition_or_measurement_approach":"Participant-completed questionnaire to derive PrEP knowledge score at specified visits."}
• {"endpoint_text":"- Number and nature of uses of community peer support and therapeutic patient education measured through a self-administrated questionnaire at baseline, 6, 12, 18 and 24 months.","definition_or_measurement_approach":"Self-administered questionnaire assessing number and type of community peer support and therapeutic education uses at scheduled visits."}

France

Earliest CTIS Part Ii Submission Date

24-07-2024

Latest Decision Or Authorization Date

14-11-2025

Processing Time Days

478

Number Of Sites

8

Number Of Participants

322

Primary sponsor

Full Name

Inserm

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Inserm-ANRS MIE","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"ViiV Healthcare","duties_or_roles":"Source of monetary support","organisation_type":""}