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A Phase II non-comparative multicenter trial Fagard C. 1, Descamps D. 2, Dubar V. 3, Colin C.1,Taburet AM. 4, Roquebert B. 2, Katlama C. 5, Jacomet C.

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Presentation on theme: "A Phase II non-comparative multicenter trial Fagard C. 1, Descamps D. 2, Dubar V. 3, Colin C.1,Taburet AM. 4, Roquebert B. 2, Katlama C. 5, Jacomet C."— Presentation transcript:

1 A Phase II non-comparative multicenter trial Fagard C. 1, Descamps D. 2, Dubar V. 3, Colin C.1,Taburet AM. 4, Roquebert B. 2, Katlama C. 5, Jacomet C. 6, Piketty C. 7, Molina JMM. 8, Chene G. 1, Yazdanpanah Y 3 and the ANRS 139 TRIO Trial Group Efficacy and safety of raltegravir plus etravirine and darunavir/ritonavir in treatment-experienced patients with multidrug-resistant virus: 48-week results from the ANRS 139 TRIO trial TUPDB204

2 ANRS 139 TRIO Trial – Cape Town Baseline characteristics (n = 103) HIV RNA log 10, copies/ml, median (IQR)4.0(3.6 – 4.6) CD4 cells/mm 3, median (IQR)255(132 – 350) CD4 Nadir in cells/mm 3, median (IQR) 79(25– 169) ART duration prior to enrollment yrs, median (IQR) 13(11 – 15) No. mutations at screening, median (IQR) Major PI4(3 – 5) NRTIs5(4 – 6) NNRTIs1(0 – 2) OBT received with RAL/ETR/DRV (%)* NRTIs 83% Enfuvirtide 12% *In 60% of 90 patients who received an OBT GSS of the OBT <1 TUPDB204

3 ANRS 139 TRIO Trial – Cape Town 2009 Proportion of patients with HIV RNA < 50 copies/ml at 48 weeks (missing = failure) 3 Wk 24 = 90%Wk 48 = 86% Median CD4 count increase from baseline to week 48 = 108/mm 3 TUPDB204

4 ANRS 139 TRIO Trial – Cape Town Clinical Adverse Events and Laboratory Abnormalities (n=103) Grade 3-4 clinical adverse events 15 (14.6%) possibly related to investigational drugs 4 ( 3.9%) Grade 3-4 laboratory adverse events 20 (19.4%) –Creatinine phosphokinase >5xULN 11 (10.7%) –Gamma-GT >5xULN 4 (3.9%) Adverse events leading to discontinuation 1 (1.0%) = grade 4 skin rash with fever Death 1 (1.0%) = myocardial infarction after aortobifemoral bypass surgery TUPDB204

5 ANRS 139 TRIO Trial – Cape Town 2009 Conclusion In patients with multi-drug resistant virus and few remaining treatment options, at 48 weeks the combination of raltegravir, etravirine and darunavir/r is well tolerated and is associated with a similar rate of virologic suppression than that expected in treatment-naïve patients. 5 TUPDB204

6 ANRS 139 TRIO Trial – Cape Town Acknowledgments The patients for their participation and their commitment during the study and the TRIO Study Group: ANRS JF Delfraissy MJ. Commoy S. Couffin-Cadiergues A. Bouxin-Metro A. Diallo CTU INSERM U897/ISPED G. Chêne C. Fagard C. Jean-Marie A. Beuscart I. Tschöpe C. Colin M. Bertoncello S. Martiren DSMB D. Costagliola J. Caron F. Berdougo D. Rey O. Patey Merck Sharpe & Dohme-Chibret (provided raltegravir) A. Aslan E. Dohin Tibotec, a division of Janssen Cilag (provided etravirine) A. Cheret MB. Hadacek SCIENTIFIC COMMITTEE Y. Yazdanpanah (Chair) G. Chêne D. Descamps V. Dubar C. Jacomet C. Katlama JM. Molina C. Piketty B. Roquebert AM. Taburet CLINICAL CENTERS Saint-Louis, Paris (JM. Molina) Pitié-Salpêtrière, Paris (C. Katlama) Tenon, Paris (G. Pialoux) Saint-Antoine, Paris (PM. Girard) Saint-Louis, Paris (D. Sereni) Tourcoing (Y. Yazdanpanah) Bichat, Paris (P. Yeni) HEGP, Paris (L. Weiss) Nantes (F. Raffi) Paul Brousse, Villejuif (D. Vittecoq) Edouard Herriot, Lyon (F. Jeanblanc) Necker, Paris (JP. Viard) Marseille (I. Poizot-Martin) Lariboisière, Paris (A. Rami) Angers (JM. Chennebault) Garches (P. De Truchis) Saint-Louis, Paris (L. Gerard) Bicêtre (C. Goujard) Nice (J. Durant) Corbeil-Essones (P. Chevojon) Besançon (C. Drobacheff) Antoine Béclère,Clamart (F. Boué) Cochin, Paris (D. Salmon-Ceron) Bordeaux (P. Morlat) Grenoble (P. Leclercq) Saint-Louis, Paris (FJ. Timsit) Saint-Denis(MA. Khuong-Josse) Hôtel-Dieu, Lyon (C. Trepo) Bordeaux (JM. Ragnaud) Belfort (JP. Faller) Nice (E. Rosenthal) Toulouse (L. Cuzin) Créteil (Y. Lévy) Avicenne, Bobigny (M. Bentata) Annecy (J. Gaillat) La Roche/Yon (P. Perré) Rennes (F. Souala) Avignon (G. Pichancourt) Mulhouse (G. Beck-Wirth) Avicenne, Bobigny(S. Abgrall) Pitié-Salpêtrière, Paris (A. Simon) Bordeaux (M. Dupon) Clermont-Ferrand (C. Jacomet) Caen (R. Verdon) Dijon (L. Piroth) Hôtel-Dieu, Paris (A. Compagnucci) Perpignan (H. Aumaitre) Tours (F. Bastides) Pontoise (L. Blum)

7 ANRS 139 TRIO Trial – Cape Town 2009 Back-up slide 7

8 ANRS 139 TRIO Trial – Cape Town 2009 Proportion of patients with HIV-RNA <50 copies/ml at week 48, according to OBT N (%) p-value All patients (n=103) OBT No13/13 (100 ) Yes76/90(84.1) 0.21 Patients with OBT(n=90) Genotypic Sensitivity Score <146/54 (85.2) 11 30/36(83.3)


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