An Open Label, Phase II Study of Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART

The purpose of this study is to study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first protease inhibitor based HAART.

开始日期2001-04-01

申办/合作机构

Abbott Laboratories

NCT00038519 / Completed临床2/3期

An Open Label, Phase II Study of Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra (Lopinavir/Ritonavir) as Their Second Protease Inhibitor.

The purpose of this study is to study the safety and efficacy of Amprenavir/ritonavir or saquinavir/ritonavir in HIV infected patients that have failed Kaletra as their second protease inhibitor based HAART.

开始日期2001-04-01

申办/合作机构

Abbott Laboratories

100 项与 Amprenavir/ritonavir 相关的临床结果

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100 项与 Amprenavir/ritonavir 相关的转化医学

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100 项与 Amprenavir/ritonavir 相关的专利（医药）

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项与 Amprenavir/ritonavir 相关的文献（医药）

2008-10-01·AIDS Research and Human Retroviruses4区 · 医学

Effect of Baseline Viral Susceptibility on Response to Darunavir/Ritonavir versus Control Protease Inhibitors in Treatment-Experienced HIV Type 1-Infected Patients: POWER 1 and 2

4区 · 医学

Article

作者: Lefebvre, Eric ; de Béthune, Marie-Pierre ; Hill, Andrew ; Beatty, George ; Opravil, Milos ; Pozniak, Anton

Data from two Phase IIb trials, POWER 1 and 2 (TMC114-C213 and C202), were pooled to examine the effect of baseline viral susceptibility on response to control protease inhibitors [CPI(s)] compared with response to darunavir (TMC114) given with low-dose ritonavir (darunavir/r) in treatment-experienced HIV patients. POWER 1 and 2 were randomized, controlled Phase IIb trials with a similar design. Patients with one or more primary PI mutations and HIV-1 RNA >1000 copies/ml were randomized to receive an optimized background regimen plus darunavir/r or CPI(s). POWER 1 and 2 week 24 efficacy (intent-to-treat using time-to-loss of virologic response algorithm) data were pooled and analyzed according to baseline subgroups of susceptibility to the CPI regimen, fold-change (FC) in EC(50) to darunavir, and number of darunavir resistance-associated mutations (RAMs). In total, 131 patients received darunavir/r 600/100 mg twice daily; 124 received CPI(s) [lopinavir/r, 20%; saquinavir/r, 19%; (fos)-amprenavir/r, 24%; atazanavir/r, 11%; and 23% used dual-boosted CPI(s)]. At baseline, 72% of patients were resistant (defined as FC) to their investigator-selected CPIs. At week 24, darunavir/r 600/100 mg twice daily provided greater efficacy benefits over CPI(s), even when the virus was predicted to be fully susceptible to the CPI. The response to darunavir decreased when FC to darunavir at baseline was >40 or when three or more darunavir RAMs (in addition to other PI mutations) were present at baseline. Darunavir/r 600/100 mg twice daily showed efficacy benefits over CPI use regardless of viral susceptibility at baseline, FC to darunavir or boosting type in a population of treatment-experienced HIV-infected patients.

2005-05-01·Antiviral Therapy4区 · 医学

Impact of Newly Available Drugs on Clinical Progression in Patients with Virological Failure after Exposure to Three Classes of Antiretrovirals

4区 · 医学

Article

作者: Picard, O ; Lesprit, Ph ; de Belfort, CH ; Billaud, E ; Mayaud, C ; Cadranel, J ; Cuzin, L ; Arlet-Suau, E ; Fournier, S ; Tassi, S ; Pialoux, JF ; Desplanque, N ; Caron, F ; Widal, GH Lariboisière-Fernand ; Goujard, C ; de Mulhouse, P Fraisse; CH ; Sobesky, M ; Sobel, A ; Honoré, P ; Dupont, C ; de Nîmes, J Reynes; CHG ; Delfraissy, JF ; Yasdanpanah, Y ; Viard, JP ; Gastaut, JA ; Jeantils, V ; Galinier, A ; Raffi, F ; de Lyon, Cisih ; Boué, F ; Duval, X ; Matheron, S ; Katlama, C ; Duvivier, Claudine ; Gaud, C ; Berthé, H ; Duvivier, C ; Boibieux, A ; Mortier, E ; Jung, C ; Weiss, L ; Rey, D ; Tirard-Fleury, V ; Bentata, M ; Retornaz, F ; Vildé, JL ; Tissot-Dupont, H ; Chandemerle, C ; Fresard, A ; Pelissier, L ; Soubeyrand, J ; Saïag, P ; Michelet, C ; Aronica, E ; Arvieux, C ; Nezri, M ; Cotte, L ; Trepo, C ; Molina, JM ; Delmont, JP ; Verdon, R ; Leneman, H ; Salmon, D ; Dupont, Caroline ; Ravaux, I ; Guiguet, M ; Blanc, PA ; Esterni, JP ; Pialoux, G ; Laffeuillade, A ; Tisne-Dessus, D ; Yeni, P ; Faller, JP ; Mechali, D ; Grabar, S ; Gerard, L ; Saidi, S ; Tattevin, P ; Leport, C ; Enel, P ; Tarnier-Cochin, GH ; Rangueil, CHU ; Lepeu, G ; de Martigues, CH ; Potard, Valérie ; Rouveix, E ; Fior, R ; Meynard, JL ; Borsa-Lebas, F ; Allegre, T ; Livrozet, JM ; Sellier, P ; Mary-Krause, M ; Rabaud, C ; Pugliese, P ; Pradier, C ; Lang, JM ; Contant, M ; Auperin, I ; Simon, A ; Abgrall, S ; Potard, V ; Gilquin, J ; Bouvet, E ; Duval, Xavier ; Diemer, M ; Poizot-Martin, I ; Salmon, Dominique ; Costagliola, D ; de Truchis, P ; de Dijon, Chru ; Legrand, MF Thiercelin ; Massip, P ; May, T ; Roudière, L ; Gasnault, J ; Cohen-Valensi, R ; d'Arles, CH ; Gaudebout, C ; Bazin, C ; Picard-Dahan, C ; Chadapaud, S ; Eglinger, P ; Laurichesse, H ; Sicard, D ; Touraine, JL ; Salmon-Ceron, D ; Costagliola, Dominique ; Rozenbaum, W ; Lièvre, L ; Ruiz, JM ; Crickx, B ; Tortay, I ; de Tourcoing, CH ; Moreau, J ; d'Avignon, CH ; Clauvel, JF ; Bricaire, F ; Granet-Brunello, P ; Herson, S ; Lucht, JF ; Decazes, JM ; Lanoy, E ; de Grenoble, Cisih ; Taverne, B ; Pradinaud, R ; Meyohas, MC ; Khuong, MA ; Peyramond, D ; Pradier, Christian ; Gourdon, F

ObjectiveTo study the prognosis of HIV-infected patients with virological failure after exposure to three classes of antiretroviral drugs (ARVs).DesignCohort study. Setting: French Hospital Database on HIV.PatientsPatients previously exposed to at least two nucleoside reverse transcriptase inhibitors (NRTIs), two protease inhibitors and one non-NRTI, with viral load (VL) values of >5000 copies/ml after the exposure criteria were met and a new treatment initiated between 1998 and 2001 with VL >5000 copies/ml.Main outcome measuresRisk of new AIDS-defining-events (ADEs) or death from first introduction of a drug never used before occurring between 1998 and 2001 defined as baseline.ResultsThe main baseline characteristics of the 1092 patients were: previous ADE in 49% of cases, median CD4 cell count 181 μl, median VL 4.9 log10copies/ml, median duration of ARV therapy 5.0 years and previous exposure to a median of nine ARVs. The crude progression rates were 20.1/100 patient-years among patients included in 1998, 15.1 in 1999, 11.1 in 2000 and 8.6 in 2001. After adjustment for baseline characteristics, the calendar year of inclusion was associated with the risk of clinical progression ( P<0.001). When the types of newly available drugs used at baseline or during follow-up were introduced into the model, year of inclusion was no longer associated with the risk of clinical progression ( P=0.42), while exposure to amprenavir/r, lopinavir/r, abacavir or tenofovir was associated with a lower risk.ConclusionsThe clinical prognosis of heavily pretreated patients experiencing virological failure improved between 1998 and 2001, mainly thanks to the use of newly available drugs with more favourable resistance profiles.

100 项与 Amprenavir/ritonavir 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
HIV感染	临床3期	意大利	Abbott Laboratories	2001-04-30
HIV感染	临床3期	加拿大	Abbott Laboratories	2001-04-30
HIV感染	临床3期	阿根廷	Abbott Laboratories	2001-04-30
HIV感染	临床3期	美国	Abbott Laboratories	2001-04-30
HIV感染	临床3期	英国	Abbott Laboratories	2001-04-30
HIV感染	临床3期	波多黎各	Abbott Laboratories	2001-04-30
HIV感染	临床3期	法国	Abbott Laboratories	2001-04-30
HIV感染	临床3期	波兰	Abbott Laboratories	2001-04-30
HIV感染	临床3期	巴西	Abbott Laboratories	2001-04-30
HIV感染	临床3期	西班牙	Abbott Laboratories	2001-04-30

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


IAS2004	N/A	代谢性疾病	43	Non-amprenavir Protease Inhibitor (PI) antiretroviral regimens	蓋顧糧淵範製廠鹽窪範(窪壓製簾構構鏇鬱顧構) = 觸糧遞網齋鏇蓋構網範積簾糧艱醖遞艱築願鬱 (構廠製鏇積鏇憲網範衊 ) 更多	-	2004-01-01
				Amprenavir/Ritonavir Antiretroviral Regimens	蓋顧糧淵範製廠鹽窪範(窪壓製簾構構鏇鬱顧構) = 衊糧遞選獵壓積鬱鹹獵積簾糧艱醖遞艱築願鬱 (構廠製鏇積鏇憲網範衊 ) 更多
ESS40001(CLASS) (IAS2004)	N/A	-	66	GW433908/ritonavir 200mg	(積醖窪鏇艱醖鏇選糧壓) = 築顧願襯壓廠鑰獵觸鑰構繭齋鏇遞選憲襯範齋 (鏇衊襯積鬱鬱網膚糧鏇 ) 更多	-	2004-01-01
				Amprenavir/ritonavir 200mg	(衊鬱顧齋廠蓋鏇製築鏇) = 齋夢憲艱鹽餘齋積製齋構壓夢鬱網衊窪獵積蓋 (窪蓋齋鏇蓋獵觸築獵範 ) 更多
ESS40001 (IAS2004)	N/A	-	291	Abacavir+Lamivudine (ABC+3TC) + Efavirenz (NNRTI)	(鏇網繭鹽繭膚獵艱簾蓋) = 衊夢獵齋鹹鏇壓鏇築製觸選艱膚淵獵廠壓簾遞 (簾艱觸糧鹽網襯淵範醖 )	-	2004-01-01
				Abacavir+Lamivudine (ABC+3TC) + Amprenavir/Ritonavir (PI)	(鏇網繭鹽繭膚獵艱簾蓋) = 鬱襯網製襯鏇餘築鏇糧觸選艱膚淵獵廠壓簾遞 (簾艱觸糧鹽網襯淵範醖 )
IAS2002	N/A	HIV感染	50	Amprenavir/ritonavir combination	襯醖願窪齋衊鬱網齋鏇(築選簾簾鹹鑰齋艱構鹹) = 鑰鹽繭艱醖積獵範鹽艱壓網憲鏇膚築憲餘襯夢 (構顧膚顧觸顧鬱構餘觸, +/ ~ 772)	-	2002-01-01
IAS2002	N/A	HIV感染	31	Amprenavir/ritonavir	顧積糧膚選襯壓網齋廠(艱鑰齋餘製鏇齋醖遞齋) = 範願遞膚構淵鑰糧廠鏇蓋壓選齋壓簾觸製觸壓 (獵襯鬱選艱網淵鑰範簾 ) 更多	-	2002-01-01
ESS40001 (IAS2002)	N/A	-	291	Abacavir/Lamivudine (ABC/3TC) + Efavirenz (NNRTI)	鹽衊觸範範鏇廠製願壓(網糧窪壓繭觸鹹鏇遞蓋) = ABC hypersensitivity was reported in 6% of subjects 齋憲壓醖艱夢簾鬱築遞 (醖願範憲繭鹽簾壓積壓 )	-	2002-01-01
				Abacavir/Lamivudine (ABC/3TC) + Amprenavir/Ritonavir (PI)