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Official Title A Phase IIb Randomized, Partially Blinded, Dose-Finding Trial of Rilpivirine (TMC278) in Antiretroviral-Naive HIV-1 Infected Subjects
Phase Phase IIB
ClinicalTrials.gov NCT00110305
Treatments
Rilpivirine
Rilpivirine
Tradename:EdurantOther Names:RPVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories PharmacologyTreatment-NaiveAdverse Effects
Funding
IndustryTibotec Pharmaceuticals, Ireland
References
- Pozniak AL, Morales-Ramirez J, Katabira E, et al. Efficacy and safety of TMC278 in antiretroviral-naive HIV-1 patients: week 96 results of a phase IIb randomized trial. AIDS. 2010;24:55-65.
- Wilkin A, Pozniak AL, Morales-Ramirez J, et al. Long-term efficacy, safety, and tolerability of rilpivirine (RPV, TMC278) in HIV type 1-infected antiretroviral-naive patients: week 192 results from a phase IIb randomized trial. AIDS Res Hum Retroviruses. 2012;28:437-46.
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
Common TitleMWRI-01 Non-Industry Industry
Official Title Phase 1 Open Label Safety, Acceptability, Pharmacokinetic and ex Vivo Pharmacodynamic Study of TMC278 Long Acting (LA) Administered Intramuscularly to HIV-1 Seronegative Individuals
Phase Phase I
ClinicalTrials.gov NCT01656018
Treatments
Rilpivirine
Rilpivirine
Tradename:EdurantOther Names:RPVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories PREP
Funding
IndustryJanssen Research & Development, LLC
Non-IndustryBill & Melinda Gates Foundation
References
- McGowan I, Dezzutti CS, Siegel A, et al. Long-acting rilpivirine as potential pre-exposure prophylaxis for HIV-1 prevention (the MWRI-01 study): an open-label, phase 1, compartmental, pharmacokinetic and pharmacodynamic assessment. Lancet HIV. 2016;3:e569-e578.
Official Title A Phase III, Randomized, Double-blind Trial of Rilpivirine (TMC278) 25mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Background Regimen Containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-naive HIV-1 Infected Subjects.
Phase Phase III
ClinicalTrials.gov NCT00543725
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)Categories Treatment-NaivePharmacologyAdverse EffectsResistance/Virological Failure
Funding
IndustryTibotec Pharmaceuticals, Ireland
References
- Cohen CJ, Andrade-Villanueva J, Clotet B, et al. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet. 2011;378:229-37.
- Cohen CJ, Molina JM, Cahn P, et al. Efficacy and safety of rilpivirine (TMC278) versus efavirenz at 48 weeks in treatment-naive HIV-1-infected patients: pooled results from the phase 3 double-blind randomized ECHO and THRIVE Trials. J Acquir Immune Defic Syndr. 2012;60:33-42.
- Nelson MR, Elion RA, Cohen CJ, et al. Rilpivirine versus efavirenz in HIV-1-infected subjects receiving emtricitabine/tenofovir DF: pooled 96-week data from ECHO and THRIVE Studies. HIV Clin Trials. 2013;14:81-91.
- Rimsky L, Van Eygen V, Hoogstoel A, et al. 96-Week resistance analyses of rilpivirine in treatment-naive, HIV-1-infected adults from the ECHO and THRIVE Phase III trials. Antivir Ther. 2013;18:967-77.
- Tebas P, Sension M, Arribas J, et al. Lipid levels and changes in body fat distribution in treatment-naive, HIV-1-Infected adults treated with rilpivirine or Efavirenz for 96 weeks in the ECHO and THRIVE trials. Clin Infect Dis. 2014;59:425-34.
- Van Eygen V, Thys K, Van Hove C, et al. Deep sequencing analysis of HIV-1 reverse transcriptase at baseline and time of failure in patients receiving rilpivirine in the phase III studies ECHO and THRIVE. J Med Virol. 2016;88:798-806.
- Vingerhoets J, Rimsky L, Van Eygen V, et al. Pre-existing mutations in the rilpivirine Phase III trials ECHO and THRIVE: prevalence and impact on virological response. Antivir Ther. 2013;18:253-6.
Rilpivirine Slide Deck
February 22, 2020
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