Ritonavir-boosted tipranavir demonstrates superior efficacy to ritonavir-boosted protease inhibitors in treatment-experienced HIV-infected patients: 24-Week results of the RESIST-2 trial

Clinical Infectious Diseases

Volumn 43, Issue 10, 2006, Pages 1347-1356

  Cahn, Pedro ^a   Villacian, Jorge ^e   Lazzarin, Adriano ^g   Katlama, Christine ^h   Grinsztejn, Beatriz ^b   Arasteh, Keikawus ^f   López, Paulo ^c   Clumeck, Nathan ⁱ   Gerstoft, Jan ^j   Stavrianeas, Nikolas ^k   Moreno, Santiago ^l   Antunes, Francisco ^m   Neubacher, Dietmar ^e   Mayers, Douglas ^d  

^a FUNDACIÓN HUÉSPED   (Argentina)

^b INSTITUTO OSWALDO CRUZ   (Brazil)

^c INSTITUTO MEXICANO DEL SEGURO SOCIAL   (Mexico)

^d BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^e BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^f Auguste Viktoria Klinikum   (Germany)

^g VITA SALUTE SAN RAFFAELE UNIVERSITY   (Italy)

^h PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

ⁱ SAINT PIERRE UNIVERSITY HOSPITAL   (Belgium)

^j Rigshospitalet   (Denmark)

^k ANDREAS SYGROS HOSPITAL   (Greece)

^l HOSPITAL RAMÓN Y CAJAL   (Spain)

^m HOSPITAL DE SANTA MARIA   (Portugal)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; AMPRENAVIR; CHOLESTEROL; ENFUVIRTIDE; INDINAVIR; LOPINAVIR; PROTEINASE INHIBITOR; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; SAQUINAVIR; TIPRANAVIR; TRIACYLGLYCEROL;

ABDOMINAL PAIN; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AMINOTRANSFERASE BLOOD LEVEL; AMYLASE BLOOD LEVEL; ANTIBIOTIC RESISTANCE; ANTIVIRAL ACTIVITY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CD4 LYMPHOCYTE COUNT; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFECT; DRUG EFFICACY; EUROPE; FEMALE; FEVER; GASTROINTESTINAL SYMPTOM; GENOTYPE; HEADACHE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERAMYLASEMIA; HYPERCHOLESTEROLEMIA; HYPERTRIGLYCERIDEMIA; LIVER DYSFUNCTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIDRUG RESISTANCE; NAUSEA; OPEN STUDY; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SOUTH AND CENTRAL AMERICA; TRIACYLGLYCEROL BLOOD LEVEL; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; VIRUS ISOLATION; VIRUS LOAD; VOMITING;

ADOLESCENT; ADULT; AGED; DRUG THERAPY, COMBINATION; FEMALE; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; MALE; MIDDLE AGED; PYRIDINES; PYRONES; RITONAVIR;

EID: 33750687934     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/508352     Document Type: Article

References (33)

1. Adams PF, Hendershot GE, Marano MA. Current estimates from the National Health Interview Survey, 1996. Vital Health Stat 10 1999; 200:1-203.
2. Selik RM, Karon JM, Ward JW. Effect of the human immunodeficiency virus epidemic on mortality from opportunistic infections in the United States in 1993. J Infect Dis 1997; 176:632-6.
3. Cingolani A, Antinori A, Rizzo MG, et al. Usefulness of monitoring HIV drug resistance and adherence in individuals failing highly active antiretroviral therapy: a randomized study (ARGENTA). AIDS 2002; 16:369-79.
4. Wit FW, van Leeuwen R, Weverling GJ, et al. Outcome and predictors of failure of highly active antiretroviral therapy: one-year follow-up of a cohort of human immunodeficiency virus type 1-infected persons. J Infect Dis 1999; 179:790-8.
5. Fatkenheuer G, Theisen A, Rockstroh J, et al. Virological treatment failure of protease inhibitor therapy in an unselected cohort of HIV-infected patients. AIDS 1997; 11:F113-6.
6. Ledergerber B, Egger M, Opravil M, et al. Clinical progression and virological failure on highly active antiretroviral therapy in HIV-1 patients: a prospective cohort study. Lancet 1999; 353:863-8.
7. Condra JH, Holder DJ, Schleif WA, et al. Genetic correlates of in vivo viral resistance to indinavir, a human immunodeficiency virus type 1 protease inhibitor. J Virol 1996; 70:8270-6.
8. Barry M, Gibbons S, Back D, Mulcahy F. Protease inhibitors in patients with HIV disease: clinically important pharmacokinetic considerations. Clin Pharmacokinet 1997; 32:194-209.
9. Condra JH, Petropoulos CJ, Ziermann R, et al. Drug resistance and predicted virologic responses to human immunodeficiency virus type 1 protease inhibitor therapy. J Infect Dis 2000; 182:758-65.
10. Boden D, Hurley A, Zhang L, et al. HIV-1 drug resistance in newly infected individuals. JAMA 1999; 282:1135-41.
11. Hertogs K, Bloor S, Kemp SD, et al. Phenotypic and genotypic analysis of clinical HIV-1 isolates reveals extensive protease inhibitor cross-resistance: a survey of over 6000 samples. AIDS 2000; 14:1203-10.
12. Deeks SG. Failure of HIV-1 protease inhibitors to fully suppress viral replication. Implications for salvage therapy. Adv Exp Med Biol 1999; 458:175-82.
13. Johnson VA, Brun-Vezinet F, Clotet B, et al. Drug resistance mutations in HIV-1. Top HIV Med 2003; 11:215-21.
14. Chrusciel RA, Strohbach JW. Non-peptidic HIV protease inhibitors. Curr Top Med Chem 2004; 4:1097-114.
15. Mehandru S, Markowitz M. Tipranavir: a novel non-peptidic protease inhibitor for the treatment of HIV infection. Expert Opin Investig Drugs 2003; 12:1821-8.
16. Randolph JT, DeGoey DA. Peptidomimetic inhibitors of HIV protease. Curr Top Med Chem 2004; 4:1079-95.
17. Larder BA, Hertogs K, Bloor S, et al. Tipranavir inhibits broadly protease inhibitor-resistant HIV-1 clinical samples. AIDS 2000; 14:1943-8.
18. Poppe SM, Slade JE, Chong KT, et al. Antiviral activity of the dihydropyrone PNU-140690, a new nonpeptidic human immunodeficiency virus protease inhibitor. Antimicrob Agents Chemother 1997; 41:1058-63.
19. Back NK, van Wijk A, Remmerswaal D, et al. In-vitro tipranavir susceptibility of HIV-1 isolates with reduced susceptibility to other protease inhibitors. AIDS 2000; 14:101-2.
20. Khaliq Y, Gallicano KC, Tisdale C, et al. Pharmacokinetic interaction between mefloquine and ritonavir in healthy volunteers. Br J Clin Pharmacol 2001; 51:591-600.
21. Koudriakova T, Iatsimirskaia E, Utkin I, et al. Metabolism of the human immunodeficiency virus protease inhibitors indinavir and ritonavir by human intestinal microsomes and expressed cytochrome P4503A4/3A5: mechanism-based inactivation of cytochrome P4503A by ritonavir. Drug Metab Dispos 1998; 26:552-61.
22. Kumar GN, Dykstra J, Roberts EM, et al. Potent inhibition of the cytochrome P-450 3A-mediated human liver microsomal metabolism of a novel HIV protease inhibitor by ritonavir: a positive drug-drug interaction. Drug Metab Dispos 1999; 27:902-8.
23. Tredger JM, Stoll S. Cytochromes P450-their impact on drug development. Hosp Pharm 2002; 9:167-73. Available at: http://www.pjonline.com/pdf/hp/200206/ hp_200206_cytochromes.pdf.
24. MacGregor TR, Sabo JP, Norris SH, et al. Pharmacokinetic characterization of different dose combinations of coadministered tipranavir and ritonavir in healthy volunteers. HIV Clin Trials 2004; 5:371-82.
25. Gathe J, Kohlbrenner VM, Pierone G, et al. Tipranavir/ritonavir demonstrates potent efficacy in multiple protease inhibitor experienced patients: BI 1182.52 [abstract 179]. In: Program and abstracts of the 10th Annual Conference on Retroviruses and Opportunistic Infections (Boston). Alexandria, VA: Foundation for Retrovirology and Human Health, 2003.
26. McCallister S, Valdez H, Curry K, et al. A 14-day dose-response study of the efficacy, safety, and pharmacokinetics of the nonpeptidic protease inhibitor tipranavir in treatment-naive HIV-1-infected patients. J Acquir Immune Defic Syndr 2004; 35:376-82.
27. Hicks C. RESIST-1: a phase 3, randomized, controlled, open-label, multicenter trial comparing tipranavir/ritonavir to an optimized comparator protease inhibitor/r regimen in antiretroviral experienced patients: 24-week data [abstract H-1137a]. In: Program and abstracts of the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy (Washington, DC). Washington, DC: American Society for Microbiology, 2004.
28. + lymphocyte counts predict both response to antiretroviral therapy and therapeutic failure. Ann Intern Med 1997; 126:939-45.
29. Demeter LM, Hughes MD, Coombs RW, et al. Predictors of virologic and clinical outcomes in HIV-1-infected patients receiving concurrent treatment with indinavir, zidovudine, and lamivudine. Ann Intern Med 2001; 135:954-64.
30. Mellors JW, Rinaldo CR Jr, Gupta P, et al. Prognosis in HIV-1 infection predicted by the quantity of virus in plasma. Science 1996; 272:1167-70.
31. Grabar S, Le Moing V, Goujard C, et al. Clinical outcome of patients with HIV-1 infection according to immunologic and virologic response after 6 months of highly active antiretroviral therapy. Ann Intern Med 2000; 133:401-10.
32. Moore N, Hall G, Sturkenboom M, et al. Biases affecting the proportional reporting ratio (PRR) in spontaneous reports pharmacovigilance databases: the example of sertindole. Pharmacoepidemiol Drug Saf 2003; 12:271-81.
33. Sabo JP, Piliero PJ, Lawton A, et al. A comparison of steady-state trough plasma ritonavir concentrations for HIV+ patients receiving an optimized background regimen and ritonavir-boosted tipranavir (TPV/r), lopinavir (LPV/r), saquinavir (SQV/r) or amprenavir (APV/r] [poster number 43]. In: Proceedings of the 7th International Workshop on Clinical Pharmacology of HIV Therapy (Lisbon). Utrecht, The Netherlands: Virology Education, 2006.