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Injectable cabotegravir and Rilpivirine (Cabenuva)
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Official Title A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current INI- NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-infected Adults Who Are Virologically Suppressed
Phase Phase III
ClinicalTrials.gov NCT02951052
Treatments
Injectable cabotegravir and Rilpivirine
Injectable cabotegravir and Rilpivirine
Tradename:CabenuvaClass:Long-Acting Injectable RegimensCategories Treatment-ExperiencedDual Therapy
Funding
IndustryViiV Healthcare and Janssen
References
- Swindells S, Andrade-Villanueva JF, Richmond GJ, et al. Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression. N Engl J Med. 2020;382:1112-23.
Official Title Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults
Phase Phase III
ClinicalTrials.gov NCT03299049
Treatments
Injectable cabotegravir and Rilpivirine
Injectable cabotegravir and Rilpivirine
Tradename:CabenuvaClass:Long-Acting Injectable RegimensCategories Treatment-ExperiencedSwitch/SimplificationDual Therapy
Funding
IndustryJanssen
References
- Overton ET, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2021;396:1994-2005.
Official Title A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants
Purpose / DescriptionPhase III
Phase Phase III
ClinicalTrials.gov NCT02938520
Treatments
Injectable cabotegravir and Rilpivirine
Injectable cabotegravir and Rilpivirine
Tradename:CabenuvaClass:Long-Acting Injectable RegimensCategories Treatment-NaiveDual Therapy
Funding
IndustryViiV Healthcare and Janssen
References
- Orkin C, Arasteh K, Górgolas Hernández-Mora M, et al. Long-Acting Cabotegravir and Rilpivirine after Oral Induction for HIV-1 Infection. N Engl J Med. 2020;382:1124-35.
Official Title A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants
Phase Phase III
ClinicalTrials.gov NCT02938520
Treatments
Injectable cabotegravir and Rilpivirine
Injectable cabotegravir and Rilpivirine
Tradename:CabenuvaClass:Long-Acting Injectable RegimensCategories Treatment-ExperiencedSwitch/SimplificationDual Therapy
Funding
IndustryViiV Healthcare and Janssen
References
- Orkin C, Oka S, Philibert P, et al. Long-acting cabotegravir plus rilpivirine for treatment in adults with HIV-1 infection: 96-week results of the randomised, open-label, phase 3 FLAIR study. Lancet HIV. 2021;8:e185-e196.
Official Title Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants
Phase Phase III
ClinicalTrials.gov NCT02938520
Treatments
Injectable cabotegravir and Rilpivirine
Injectable cabotegravir and Rilpivirine
Tradename:CabenuvaClass:Long-Acting Injectable RegimensCategories Treatment-ExperiencedSwitch/SimplificationDual Therapy
Funding
IndustryViiV Healthcare and Janssen
References
- Orkin C, Bernal Morell E, Tan DHS, et al. Initiation of long-acting cabotegravir plus rilpivirine as direct-to-injection or with an oral lead-in in adults with HIV-1 infection: week 124 results of the open-label phase 3 FLAIR study. Lancet HIV. 2021;8:e668-e678.
Official Title Phase IIb, Dose Ranging Study of Oral Cabotegravir (GSK1265744) in Combination With Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus -1 (HIV-1) Virologic Suppression Followed by an Evaluation of Maintenance of Virologic Suppression When Oral Cabotegravir (GSK1265744) is Combined With Oral Rilpivirine in HIV-1 Infected, Antiretroviral Therapy Naive Adult Subjects
Phase Phase IIB
ClinicalTrials.gov NCT01641809
Treatments
Injectable cabotegravir and Rilpivirine
Injectable cabotegravir and Rilpivirine
Tradename:CabenuvaClass:Long-Acting Injectable RegimensCategories Treatment-NaiveDual Therapy
Funding
IndustryViiV Healthcare
References
- Margolis DA, Brinson CC, Smith GH, et al. Cabotegravir plus rilpivirine, once a day, after induction with cabotegravir plus nucleoside reverse transcriptase inhibitors in antiretroviral-naive adults with HIV-1 infection (LATTE): a randomised, phase 2b, dose-ranging trial. Lancet Infect Dis. 2015;15:1145-55.
Official Title A Phase IIb Study Evaluating a Long-Acting Intramuscular Regimen of Cabotegravir (GSK1265744) Plus Rilpivirine (TMC278) For The Maintenance of Virologic Suppression Following an Induction of Virologic Suppression on an Oral Regimen of Cabotegravir (GSK1265744) Plus Abacavir/Lamivudine in HIV-1 Infected, Antiretroviral Therapy-Naive Adult Subjects
Phase Phase IIB
ClinicalTrials.gov NCT02120352
Treatments
Injectable cabotegravir and Rilpivirine
Injectable cabotegravir and Rilpivirine
Tradename:CabenuvaClass:Long-Acting Injectable RegimensCategories Treatment-NaiveDual Therapy
Funding
IndustryViiV Healthcare
References
- Margolis DA, Gonzalez-Garcia J, Stellbrink HJ, et al. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial. Lancet. 2017;390:1499-1510.
Official Title Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study
Phase Phase IIB
ClinicalTrials.gov NCT03639311
Treatments
Injectable cabotegravir and Rilpivirine
Injectable cabotegravir and Rilpivirine
Tradename:CabenuvaClass:Long-Acting Injectable RegimensCategories Switch/Simplification
Funding
IndustryViiV Healthcare and Janssen
References
- Mills A, Richmond GJ, Newman C, et al. Long-acting cabotegravir and rilpivirine for HIV-1 suppression: switch to 2-monthly dosing after 5 years of daily oral therapy. AIDS. 2022;36:195-203.
Official Title A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every Two Months From a Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in HIV-1 Infected Adults Who Are Virologically Suppressed
Purpose / DescriptionThis study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.
Phase Phase IIIB
ClinicalTrials.gov NCT04542070
Treatments
Injectable cabotegravir and Rilpivirine
Injectable cabotegravir and Rilpivirine
Tradename:CabenuvaClass:Long-Acting Injectable RegimensCategories Treatment-ExperiencedSwitch/Simplification
Funding
IndustryViiV Healthcare
References
- Ramgopal MN, Castagna A, Cazanave C, et al. Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a randomised, open-label, phase 3b, non-inferiority trial. Lancet HIV. 2023;10:e566-e577.