Efficacy of the protease inhibitors tipranavir plus ritonavir in treatment-experienced patients: 24-Week analysis from the RESIST-1 trial

Clinical Infectious Diseases

Volumn 43, Issue 10, 2006, Pages 1337-1346

  Gathe, Joseph ^a   Cooper, David A ^j   Farthing, Charles ^b   Jayaweera, Dushyantha ^c   Norris, Dorece ^e   Pierone Jr , Gerald ^f   Steinhart, Corklin R ^d   Trottier, Benoit ^h   Walmsley, Sharon L ⁱ   Workman, Cassy ^k   Mukwaya, Geoffrey ^g   Kohlbrenner, Veronika ^g   Dohnanyi, Catherine ^g   McCallister, Scott ^g   Mayers, Douglas ^g  

^a Therapeutic Concepts   (United States)

^b AIDS HEALTHCARE FOUNDATION   (United States)

^c UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^d Steinhart Medical Associates   (United States)

^e Research Institute   (United States)

^f AIDS Research and Treatment Center of the Treasure Coast   (United States)

^g BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^h UNIVERSITÉ DU QUÉBEC À MONTRÉAL   (Canada)

ⁱ UNIVERSITY OF TORONTO   (Canada)

^j UNIVERSITY OF NEW SOUTH WALES   (Australia)

^k AIDS Research Initiative   (Australia)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; AMPRENAVIR; AMYLASE; ANTIRETROVIRUS AGENT; ASPARTATE AMINOTRANSFERASE; CHOLESTEROL; GLUCOSE; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; INDINAVIR; LOPINAVIR; PROTEINASE INHIBITOR; RITONAVIR; SAQUINAVIR; TIPRANAVIR; TRIACYLGLYCEROL; TRIACYLGLYCEROL LIPASE;

ABDOMINAL PAIN; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AMYLASE BLOOD LEVEL; ANTIBIOTIC RESISTANCE; ANTIVIRAL ACTIVITY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; AUSTRALIA; CD4 LYMPHOCYTE COUNT; CEREBROVASCULAR ACCIDENT; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFECT; DRUG EFFICACY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FEVER; GENOTYPE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERAMYLASEMIA; HYPERCHOLESTEROLEMIA; HYPERGLYCEMIA; HYPERTRIGLYCERIDEMIA; INJECTION SITE REACTION; LIVER DYSFUNCTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIDRUG RESISTANCE; NAUSEA; NORTH AMERICA; OPEN STUDY; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEPSIS; TRIACYLGLYCEROL BLOOD LEVEL; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; UPPER RESPIRATORY TRACT INFECTION; VIRUS ISOLATION; VIRUS LOAD; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; CD4 LYMPHOCYTE COUNT; DRUG THERAPY, COMBINATION; FEMALE; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; MALE; MIDDLE AGED; PYRIDINES; PYRONES; RITONAVIR; VIRAL LOAD;

EID: 33750722853     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/508353     Document Type: Article

References (39)

1. Palella FJ Jr, Delaney KM, Moorman AC, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med 1998; 338:853-60.
2. 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.
3. 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.
4. Deeks SG. Determinants of virological response to antiretroviral therapy: implications for long-term strategies. Clin Infect Dis 2000; 30(Suppl 2):S177-84.
5. 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. Swiss HIV Cohort Study. Lancet 1999; 353:863-8.
6. Dieleman JP, Jambroes M, Gyssens IC, et al. Determinants of recurrent toxicity-driven switches of highly active antiretroviral therapy. The ATHENA cohort. AIDS 2002; 16:737-45.
7. Raboud JM, Harris M, Rae S, Montaner JS. Impact of adherence on duration of virological suppression among patients receiving combination antiretroviral therapy. HIV Med 2002; 3:118-24.
8. Condra JH, Petropoulos CJ, Ziermann R, Schleif WA, Shivaprakash M, Emini EA. Drug resistance and predicted virologic responses to human immunodeficiency virus type 1 protease inhibitor therapy. J Infect Dis 2000; 182:758-65.
9. 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.
10. Van Vaerenbergh K, Van Laethem K, Albert J, et al. Prevalence and characteristics of multinucleoside-resistant human immunodeficiency virus type 1 among European patients receiving combinations of nucleoside analogues. Antimicrob Agents Chemother 2000; 44:2109-17.
11. Johnson VA, Brun-Vezinet F, Clotet B, et al. Drug resistance mutations in HIV-1. Top HIV Med 2003; 11:215-21.
12. Lundgren JD, Ledergerber B, Fusco GP, et al. Risk of death following triple class virological failure: the PLATO collaboration [abstract H-450]. In: Program and abstracts of the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy (Chicago). Washington, DC: American Society for Microbiology, 2003.
13. Chrusciel RA, Strohbach JW. Non-peptidic HIV protease inhibitors. Curr Top Med Chem 2004; 4:1097-114.
14. 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.
15. Randolph JT, DeGoey DA. Peptidomimetic inhibitors of HIV protease. Curr Top Med Chem 2004; 4:1079-95.
16. Larder BA, Hertogs K, Bloor S, et al. Tipranavir inhibits broadly protease inhibitor-resistant HIV-1 clinical samples. AIDS 2000; 14:1943-8.
17. Poppe SM, Slade DE, 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.
18. 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.
19. Khaliq Y, Gallicano K, Tisdale C, Carignan G, Cooper C, McCarthy A. Pharmacokinetic interaction between mefloquine and ritonavir in healthy volunteers. Br J Clin Pharmacol 2001; 51:591-600.
20. Koudriakova T, Iatsimirskaia E, Utkin I, Gangl E, Vouros P, Storozhuk E. 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.
21. Kumar GN, Dykstra J, Roberts EM, Jayanti VK, Hickman D. 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.
22. Tredger JM, Stoll S. Cytochromes P450-their impact on drug development. Hospital Pharmacist 2002; 9:167-73.
23. MacGregor TR, Sabo JP, Norris SH, Johnson P, Galitz L, McCallister S. Pharmacokinetic characterization of different dose combinations of coadministered tipranavir and ritonavir in healthy volunteers. HIV Clin Trials 2004; 5:371-82.
24. 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.
25. Cooper D, Hicks C, Cahn P, et al. 24-week RESIST study analyses: the efficacy of tipranavir/ritonavir is superior to lopinavir/ritonavir, and the TPV/r treatment response is enhanced by inclusion of genotypically active antiretrovirals in the optimized background regimen [abstract 560]. In: Program and abstracts of the 12th Conference on Retroviruses and Opportunistic Infections (Denver). Alexandria, VA: Foundation for Retrovirology and Human Health, 2006.
26. Cahn P, Villacian J, Lazzarin A, et al. 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. Clin Infect Dis 2006;43:1347-56 (in this issue).
27. Ledergerber B, Lundgren JD, Walker AS, et al. Predictors of trend in CD4-positive T-cell count and mortality among HIV-1-infected individuals with virological failure to all three antiretroviral-drug classes. Lancet 2004; 364:51-62.
28. 2 tests. Biometrics 1954; 10:417-51.
29. + lymphocyte counts predict both response to antiretroviral therapy and therapeutic failure. VA Cooperative Study Group on AIDS. Ann Intern Med 1997; 126:939-45.
30. Mellors JW, Rinaldo CR Jr, Gupta P, White RM, Todd JA, Kingsley LA. Prognosis in HIV-1 infection predicted by the quantity of virus in plasma. Science 1996; 272:1167-70.
31. Human immunodeficiency virus type 1 RNA level and CD4 count as prognostic markers and surrogate end points: a meta-analysis. HIV Surrogate Marker Collaborative Group. AIDS Res Hum Retroviruses 2000; 16:1123-33.
32. Cameron DW, Heath-Chiozzi M, Danner S, et al. Randomised placebo-controlled trial of ritonavir in advanced HIV-1 disease. The Advanced HIV Disease Ritonavir Study Group. Lancet 1998; 351:543-9.
33. Lalezari JP, Henry K, O'Hearn M, et al. Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America. N Engl J Med 2003; 348:2175-85.
34. Lazzarin A, Clotet B, Cooper D, et al. Efficacy of enfuvirtide in patients infected with drug-resistant HIV-1 in Europe and Australia. N Engl J Med 2003; 348:2186-95.
35. DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents - A Working Group of the Office of AIDS Research Advisory Council (OARAC). Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Available at: http://aidsinfo .nih.gov/ContentFiles/ AdultandAdolescentGL.pdf. Accessed 26 May 2006.
36. Murphy RL, Brun S, Hicks C, et al. ABT-378/ritonavir plus stavudine and lamivudine for the treatment of antiretroviral-naive adults with HIV-1 infection: 48-week results. AIDS 2001;15:F1-9.
37. Pulido F, Katlama C, Marquez M, et al. A randomized study investigating the efficacy and safety of amprenavir in combination with low-dose ritonavir in protease inhibitor-experienced HIV-infected adults. HIV Med 2004; 5:296-302.
38. Sabo JP, Piliero PJ, Lawton A, MacGregor TR, Leith J. 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 43]. In: Proceedings of the 7th International Workshop on Clinical Pharmacology of HIV Therapy (Lisbon). Utrecht, The Netherlands: Virology Education, 2006.
39. Moore N, Hall G, Sturkenboom M, Mann R, Lagnaoui R, Begaud B. Biases affecting the proportional reporting ratio (PPR) in spontaneous reports pharmacovigilance databases: the example of sertindole. Pharmacoepidemiol Drug Saf 2003; 12:271-81.