Bictegravir-Tenofovir alafenamide-Emtricitabine Biktarvy
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Dolutegravir-Lamivudine Dovato
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Doravirine-Tenofovir DF-Lamivudine Delstrigo
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Rilpivirine-Tenofovir DF-Emtricitabine (Complera)
Other Names: RPV-TDF-FTC, Rilpivirine-Tenofovir disoproxil fumarate-EmtricitabineAll Clinical Trials
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Official Title A Phase III, Randomized, Double-blind Trial of Rilpivirine (TMC278) 25 mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Fixed Background Regimen Consisting of Tenofovir Disoproxil Fumarate and Emtricitabine in Antiretroviral-naive HIV-1 Infected Subjects.
Phase Phase III
ClinicalTrials.gov NCT00540449
Treatments
Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Rilpivirine
, Rilpivirine
Tradename:EdurantOther Names:RPVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Efavirenz-Tenofovir DF-Emtricitabine
, Efavirenz-Tenofovir DF-Emtricitabine
Tradename:AtriplaOther Names:EFV-TDF-FTC, Efavirenz-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensRilpivirine-Tenofovir DF-Emtricitabine
Rilpivirine-Tenofovir DF-Emtricitabine
Tradename:CompleraOther Names:RPV-TDF-FTC, Rilpivirine-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensFunding
IndustryTibotec Pharmaceuticals, Ireland
References
No references available for this clinical trial
Official Title Safety, Tolerability, and Adherence to Co-formulated Emtricitabine-rilpivirine-tenofovir Used as HIV Nonoccupational Post Exposure Prophylaxis in Men Who Have Sex With Men (EPEP)
Phase Phase IV
ClinicalTrials.gov NCT01715636
Treatments
Rilpivirine-Tenofovir DF-Emtricitabine
Rilpivirine-Tenofovir DF-Emtricitabine
Tradename:CompleraOther Names:RPV-TDF-FTC, Rilpivirine-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensCategories PharmacologyAdverse EffectsPEP
Funding
IndustryGilead Sciences
References
- Foster R, McAllister J, Read TR, et al. Single-tablet emtricitabine-rilpivirine-tenofovir as HIV postexposure prophylaxis in men who have sex with men. Clin Infect Dis. 2015;61:1336-41.
Official Title A Phase 2B Open Label Pilot Study to Evaluate Switching From a Regimen Consisting of a Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Single Tablet Regimen (STR) to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) STR in Virologically Suppressed, HIV 1 Infected Subjects
Phase Phase IIB
ClinicalTrials.gov NCT01286740
Treatments
Rilpivirine-Tenofovir DF-Emtricitabine
Rilpivirine-Tenofovir DF-Emtricitabine
Tradename:CompleraOther Names:RPV-TDF-FTC, Rilpivirine-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensCategories PharmacologySwitch/SimplificationAdverse Effects
Funding
IndustryGilead Sciences
References
- Mills AM, Cohen C, Dejesus E, et al. Efficacy and safety 48 weeks after switching from efavirenz to rilpivirine using emtricitabine/tenofovir disoproxil fumarate-based single-tablet regimens. HIV Clin Trials. 2013;14:216-33.
Official Title Hepatic Safety of Eviplera® in HIV/Hepatitis C (HCV)-Coinfected Patients Without HCV Treatment in the "The HEPAVIR HEPATIC SAFETY Cohort." hEPAtic Study.
ClinicalTrials.gov NCT02196064
Treatments
Rilpivirine-Tenofovir DF-Emtricitabine
Rilpivirine-Tenofovir DF-Emtricitabine
Tradename:CompleraOther Names:RPV-TDF-FTC, Rilpivirine-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensCategories PharmacologyTreatment-NaiveAdverse Effects
Funding
IndustryGilead Sciences
References
- Neukam K, Espinosa N, Collado A, et al. Hepatic Safety of Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate Fixed-Dose Single-Tablet Regimen in HIV-Infected Patients with Active Hepatitis C Virus Infection: The hEPAtic Study. PLoS One. 2016;11:e0155842.
Official Title Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir in Virologically-suppressed HIV-infected Rwandans (Near-Rwanda)
Phase Phase III
ClinicalTrials.gov NCT02104700
Treatments
Rilpivirine-Tenofovir DF-Emtricitabine
Rilpivirine-Tenofovir DF-Emtricitabine
Tradename:CompleraOther Names:RPV-TDF-FTC, Rilpivirine-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensCategories Treatment-ExperiencedSwitch/Simplification
Funding
IndustryGilead Sciences
References
- Collins SE, Grant PM, Uwinkindi F, et al. A Randomized Switch From Nevirapine-Based Antiretroviral Therapy to Single Tablet Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate in Virologically Suppressed Human Immunodeficiency Virus-1-Infected Rwandans. Open Forum Infect Dis. 2016 Sep;3:ofw141.
Official Title A Phase 3 Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Regimen in Virologically Suppressed, HIV-1 Infected Patients
Phase Phase III
ClinicalTrials.gov NCT01252940
Treatments
Rilpivirine-Tenofovir DF-Emtricitabine
Rilpivirine-Tenofovir DF-Emtricitabine
Tradename:CompleraOther Names:RPV-TDF-FTC, Rilpivirine-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensCategories PharmacologyTreatment-ExperiencedAdverse EffectsSwitch/SimplificationResistance/Virological Failure
Funding
IndustryGilead Sciences
References
- Brunetta J, Moreno Guillén S, Antinori A, et al. Patient-Reported Outcomes After a Switch to a Single-Tablet Regimen of Rilpivirine, Emtricitabine, and Tenofovir DF in HIV-1-Positive, Virologically Suppressed Individuals: Additional Findings From a Randomized, Open-Label, 48-Week Trial. Patient. 2015;8:257-67.
- Palella FJ Jr, Fisher M, Tebas P, et al. Simplification to rilpivirine/emtricitabine/tenofovir disoproxil fumarate from ritonavir-boosted protease inhibitor antiretroviral therapy in a randomized trial of HIV-1 RNA-suppressed participants. AIDS. 2014;28:335-44.
- Porter DP, Toma J, Tan Y, et al. Clinical Outcomes of Virologically-Suppressed Patients with Pre-existing HIV-1 Drug Resistance Mutations Switching to Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate in the SPIRIT Study. HIV Clin Trials. 2016;17:29-37.
Official Title A Phase 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Phase Phase IIIB
ClinicalTrials.gov NCT01309243
Treatments
Efavirenz-Tenofovir DF-Emtricitabine
, Efavirenz-Tenofovir DF-Emtricitabine
Tradename:AtriplaOther Names:EFV-TDF-FTC, Efavirenz-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensRilpivirine-Tenofovir DF-Emtricitabine
Rilpivirine-Tenofovir DF-Emtricitabine
Tradename:CompleraOther Names:RPV-TDF-FTC, Rilpivirine-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensCategories Treatment-NaiveResistance/Virological FailurePharmacologyAdverse Effects
Funding
IndustryGilead Sciences
References
- Cohen C, Wohl D, Arribas JR, et al. Week 48 results from a randomized clinical trial of rilpivirine/emtricitabine/tenofovir disoproxil fumarate vs. efavirenz/emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV-1-infected adults. AIDS. 2014;28:989-97.
- Porter DP, Daeumer M, Thielen A, et al. Emergent HIV-1 Drug Resistance Mutations Were Not Present at Low-Frequency at Baseline in Non-Nucleoside Reverse Transcriptase Inhibitor-Treated Subjects in the STaR Study. Viruses. 2015;7:6360-70.
- Porter DP, Kulkarni R, Fralich T, Miller MD, White KL. 96-week resistance analyses of the STaR study: rilpivirine/emtricitabine/tenofovir DF versus efavirenz/emtricitabine/tenofovir DF in antiretroviral-naive, HIV-1-infected subjects. HIV Clin Trials. 2015;16:30-8.
- Porter DP, Kulkarni R, Fralich T, Miller MD, White KL. Characterization of HIV-1 drug resistance development through week 48 in antiretroviral naive subjects on rilpivirine/emtricitabine/tenofovir DF or efavirenz/emtricitabine/tenofovir DF in the STaR study (GS-US-264-0110). J Acquir Immune Defic Syndr. 2014;65:318-26.
- van Lunzen J, Antinori A, Cohen CJ, et al. Rilpivirine vs. efavirenz-based single-tablet regimens in treatment-naive adults: week 96 efficacy and safety from a randomized phase 3b study. AIDS. 2016;30:251-9.
- Wilkins EL, Cohen CJ, Trottier B, et al. Patient-reported outcomes in the single-tablet regimen (STaR) trial of rilpivirine/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate in antiretroviral treatment-naive adults infected with HIV-1 through 48 weeks of treatment. AIDS Care. 2016;28:401-8.
Rilpivirine-Tenofovir DF-Emtricitabine Slide Deck
December 17, 2022
Clinical Trial Image Decks
GS-264-0111 - January 21, 2020
hEPAtic - January 21, 2020
NEAR Rwanda - December 18, 2022
SPIRIT - December 18, 2022