Indinavir: The forgotten HIV-protease inhibitor. Does it still have a role?

Expert Opinion on Pharmacotherapy

Volumn 8, Issue 7, 2007, Pages 957-964

  Boyd, Mark ^a  

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

Author keywords

HIV; Indinavir; Resource limited setting; Ritonavir boosted protease inhibitor

Indexed keywords

AMPRENAVIR PHOSPHATE; ANTIVIRUS AGENT; ATAZANAVIR; COTRIMOXAZOLE; DARUNAVIR; EFAVIRENZ; INDINAVIR; INDINAVIR PLUS RITONAVIR; INHIBISAM; LAMIVUDINE; LAMIVUDINE PLUS ZIDOVUDINE; LOPINAVIR; NELFINAVIR; PROTEINASE INHIBITOR; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; SAQUINAVIR; STAVUDINE; TIPRANAVIR; UNCLASSIFIED DRUG; ZIDOVUDINE;

ABSENCE OF SIDE EFFECTS; ANTIVIRAL ACTIVITY; AREA UNDER THE CURVE; ARTICLE; BRAIN HEMORRHAGE; CHRONIC KIDNEY FAILURE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; DOSAGE SCHEDULE COMPARISON; DRUG ABSORPTION; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG METABOLISM; DRUG POTENTIATION; DRUG RESPONSE; DRUG STRUCTURE; DRUG SUBSTITUTION; DRUG WITHDRAWAL; DRY SKIN; FOOD DRUG INTERACTION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERBILIRUBINEMIA; LIPID DIET; LOW DRUG DOSE; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; NAIL DYSTROPHY; NEPHROLITHIASIS; NEPHROTOXICITY; POSTMARKETING SURVEILLANCE; PROTEIN DIET; UNSPECIFIED SIDE EFFECT; ANTIBIOTIC RESISTANCE; DRUG COMBINATION; REVIEW;

CLINICAL TRIALS; DRUG RESISTANCE, VIRAL; DRUG THERAPY, COMBINATION; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HUMANS; INDINAVIR; PRODUCT SURVEILLANCE, POSTMARKETING; RITONAVIR;

EID: 34249733125     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656566.8.7.957     Document Type: Article

References (43)

1. PERELSON AS, NEUMANN AU, MARKOWITZ M, LEONARD JM, HO DD: HIV-1 dynamics in vivo: virion clearance rate, infected cell life-span, and viral generation time. Science (1996) 271(5255):1582-1586.
2. MARSCHNER IC, COLLIER AC, COOMBS RW et al.: Use of changes in plasma levels of human immunodeficiency virus Type 1 RNA to assess the clinical benefit of antiretroviral therapy. J. Infect. Dis. (1998) 177(1):40-47.
3. MELLORS JW, MUNOZ A, GIORGI JV et al.: Plasma viral load and CD4+ lymphocytes as prognostic markers of HIV-1 infection. Ann. Intern. Med. (1997) 126(12):946-954.
4. GULICK RM, MELLORS JW, HAVLIR D et al.: Treatment with indinavir, zidovudine, and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy. N. Engl. J. Med. (1997) 337(11)734-739.
5. MONTANER JS, REISS P, COOPER D et al.. A randomized, double-blind trial comparing combinations of nevirapine, didanosine, and zidovudine for HIV-infected patients: the INCAS Trial. Italy, The Netherlands, Canada and Australia Study. JAMA (1998) 279(12):930-937.
6. HAMMER SM, SQUIRES KE, HUGHES MD et al.: A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Team. N. Engl. J. Med. (1997) 337(11):725-733.
7. DORSEY BD, LEVIN RB, MCDANIEL SL et al.: L-735,524: the design of a potent and orally bioavailable HIV protease inhibitor. J. Med. Chem. (1994) 37(21):3443-3451.
8. BALANI SK, ARISON BH, MATHAI L et al.: Metabolites of L-735,524, a potent HIV-1 protease inhibitor, in human urine. Drug Metab. Dispos. (1995) 23(2):266-270.
9. DEUTSCH P, TEPPLER H, SQUIRES K et al.: Antiviral activity of L-735,524, an HIV protease inhibitor in infected patients. Program and abstracts of the 34th Interscience Conference on Antimicrobial Agents and Chemotherapy. Orlando, USA (1994) Abstract 159.
10. STEIGBEL RT, BERRY B MELLORS J, MAHON D: Efficacy and safety of the HIV protease inhibitor indinavir sulfate (MK 639) at escalating dose. Program and abstracts of the 4th International Conference on Retroviruses and Opportunistic Infections. Washington, DC, USA (22-26 January 1996). Abstract 146.
11. BOYD MA, SRASUEBKUL P, KHONGPHATTANAYOTHIN M et al.: Boosted versus unboosted indinavir with zidovudine and lamivudine in nucleoside pre-treated patients: a randomized, open-label trial with 112 weeks of follow-up (HIV-NAT 005). Antivir. Ther. (2006) 11(2):223-232.
12. AVIHINGSANON A, KERR SJ, BOYD MA et al.: Long-term efficacy, safety, and tolerability of indinavir-based therapy in nucleoside experienced HIV-1-infected patients in a resource limited setting: 272 week follow-up of the HIV-NAT 005 study. Program and abstracts of the XVI international AIDS Conference. Toronto, Canada (13 - 18 August 2006). Abstract no. WEPE0121.
13. ARNAIZ JA, MALLOLAS J, PODZAMCZER D et al.: Continued indinavir versus switching to indinavir/ritonavir in HTV-infected patients with suppressed viral load. AIDS (2003) 17(6):831-840.
14. DRAGSTED UB, GERSTOFT J, PEDERSEN C et al.: Randomized trial to evaluate indinavir/ritonavir versus saquinavir/ritonavir in human immunodeficiency virus Type 1-infected patients: the MaxCmin1 Trial. J. Infect. Dis. (2003) 188(5):635-642.
15. BURGER D, BOYD M, DUNCOMBE C et al.: Pharmacokinetics and pharmacodynamics of indinavir with or without low-dose ritonavir in HIV-infected Thai patients. J. Antimicrob. Chemother. (2003) 51(5):1231-1238.
16. SOLAS C, BASSOS, POIZOT-MARTIN I et al.: High indinavir Cmin is associated with higher toxicity in patients on indinavir-ritonavir 800/ 100 mg twice-daily regimen. J. Acquir. Immune Defic. Syndr. (2002) 29(4):374-377.
17. STASZEWSKI S, MORALES-RAMIREZ J, TASHIMA KT et al.: Efavirenz plus zidovudine and lamivudine, efavirenz plus indinavir, and indinavir plus zidovudine and lamivudine in the treatment of HIV-1 infection in adults. Study 006 Team. N. Engl. J. Med. (1999) 341(25):1865-1873.
18. BOYD MA, SIANGPHOE U, RUXRUNGTHAM K et al.: Indinavir/ritonavir 800/100 mg bid and efavirenz 600 mg qd in patients failing treatment with combination nucleoside reverse transcriptase inhibitors: 96-week outcomes of HIV-NAT 009. HIV Med. (2005) 6(6):410-420.
19. AVIHINGSANON A, BOYD MA, PORNPRASIT P et al.: Long term durability of boosted indinavir and efavirenz in patients with combination nucleoside failure in a resource constrained setting: 4-year follow-up of HIV-NAT 009. Program and abstracts of the XVI International AIDS Conference. Toronto, Canada (13 - 18 August 2006). Poster THPE0126.
20. BOYD MA, AARNOUTSE RE, RUXRUNGTHAM K et al.: Pharmacokinetics of indinavir/ritonavir (800/100 mg) in combination with efavirenz (600 mg) in HIV-1-infected subjects. J. Acquir. Immune Defic. Syndr. (2003) 34(2):134-139.
21. ZUCKER SD, QIN X, ROUSTER SD et al.: Mechanism of indinavir-induced hyperbilirubinemia. Proc. Natl Acad. Sci. USA (2001) 98(22):12671-12676.
22. BOYD MA, SRASUEBKUL P, RUXRUNGTHAM K et al.: Relationship between hyperbilirubinaemia and UDP-glucuronosyltransferase 1A1 (UGT1A1) polymorphism in adult HIV-infected Thai patients treated with indinavir. Pharmacogenet. Genomics (2006) 16(5):321-329.
23. KOPP JB, MILLER KD, MICAN JA et al.: Crystalluria and urinary tract abnormalities associated with indinavir. Ann. Intern. Med. (1997) 127(2):119-125.
24. BOUBAKER K, SUDRE P, BALLY F et al.: Changes in renal function associated with indinavir. AIDS (1998) 12(18):F249-F254.
25. DIELEMAN JP, GYSSENS IC, VAN DER ENDE ME, DE MARIE S, BURGER DM: Urological complaints in relation to indinavir plasma concentrations in HIV-infected patients. AIDS (1999) 13(4):473-478.
26. BOYD MA, SIANGPHOE U, RUXRUNGTHAM K et al.: The use of pharmacokinetically guided indinavir dose reductions in the management of indinavir-associated renal toxicity. J. Antimicrob. Chemother. (2006) 57(6):1161-1167.
27. MERAVIGLIA P, ANGELI E, DEL SORBO F et al.: Risk factors for indinavir-related renal colic in HIV patients: predictive value of indinavir dose/body mass index. AIDS (2002) 16(15):2089-2093.
28. MARTINEZ E, LEGUIZAMON M, MALLOLAS J, MIRO JM, GATELL JM: Influence of environmental temperature on incidence of indinavir-related nephrolithiasis. Clin. Infect. Dis. (1999) 29(2):422-425.
29. HSU A, GRANNEMAN GR, CAO G et al.: Pharmacokinetic interaction between ritonavir and indinavir in healthy volunteers. Antimicrob. Agents Chemother. (1998) 42(11):2784-2791.
30. GHOSN J, LAMOTTE C, AIT-MOHAND H et al.: Efficacy of a twice-daily antiretroviral regimen containing 100 mg ritonavir/400 mg indinavir in HIV-infected patients. AIDS (2003) 17(2):209-214.
31. DUVIVIER C, MYRTO A, MARCELIN AG et al.: Efficacy and safety of ritonavir/indinavir 100/400 mg twice daily in combination with two nucleoside analogues in antiretroviral treatment-naive HIV-infected individuals. Antivir. Ther. (2003) 8(6):603-609.
32. WASMUTH JC, LA PORTE CJ, SCHNEIDER K, BURGER DM, ROCKSTROH JK: Comparison of two reduced-dose regimens of indinavir (600 mg versus 400 mg twice daily) and ritonavir (100 mg twice daily) in healthy volunteers (COREDIR). Antivir. Ther. (2004) 9(2):213-220.
33. LEE LS, PANCHALINGAM A, YAP MC, PATON NI: Pharmacokinetics of indinavir at 800, 600, and 400 milligrams administered with ritonavir at 100 milligrams and efavirenz in ethnic chinese patients infected with human immunodeficiency virus. Antimicrob. Agents Chemother. (2004) 48(11):4476-4478.
34. KONOPNICKI D, DE WIT S, POLL B, CROMMENTUYN K, HUITEMA A, CLUMECK N: Indinavir/ritonavir-based therapy in HIV-1-infected antiretroviral therapy-naive patients: comparison of 800/100 mg and 400/100 mg twice daily. HIV Med. (2005) 6(1):1-6.
35. RHAME FS, RAWLINS SL, PETRUSCHKE RA et al.: Pharmacokinetics of indinavir and ritonavir administered at 667 and 100 milligrams, respectively, every 12 hours compared with indinavir administered at 800 milligrams every 8 hours in human immunodeficiency virus-infected patients. Antimicrob. Agents Chemother. (2004) 48(11):4200-4208.
36. MOOTSIKAPUN P, CHETCHOTISAKD P, ANUNNATSIRI S, BOONYAPRAWIT P: Efficacy and safety of indinavir/ritonavir 400/100 mg twice daily plus two nucleoside analogues in treatment-naive HIV-1-infected patients with CD4+ T-cell counts < 200 cells/mm3: 96-week outcomes. Antivir. Ther. (2005) 10(8):911-916.
37. BOYD M, MOOTSIKAPUN P, BURGER D et al.: Pharmacokinetics of reduced-dose indinavir/ritonavir 400/100 mg twice daily in HIV-1-infected Thai patients. Antivir. Ther. (2005) 10(2):301-307.
38. CRESSEY TR, LEENASIRIMAKUL P, JOURDAIN G et al.: Low-doses of indinavir boosted with ritonavir in HIV-infected Thai patients: pharmacokinetics, efficacy and tolerability. J. Antimicrob. Chemother. (2005) 55(6):1041-1044.
39. JUSTESEN US, LEVRING AM, THOMSEN A, LINDBERG JA, PEDERSEN C, TAURIS P: Low-dose indinavir in combination with low-dose ritonavir: steady-state pharmacokinetics and long-term clinical outcome follow-up. HIV Med. (2003) 4(3):250-254.
40. JOHNSON VA, BRUN-VEZINET F, CLOTET B, KURITZKES D, PILLAY D, SCHAPIRO JM, RICHMAN DD: Update of the drug resistance mutations in HIV-1: Fall 2006. Topics in HIV Medicine (2006) 14:125-130.
41. ZALA C, ALEXANDER CS, OCHOA C et al.: Comparable pharmacokinetics of generic indinavir (Inhibisam) versus brand indinavir (Crixivan) when boosted with ritonavir. J. Acquir. Immune Defic. Syndr. (2005) 38(3):363-364.
42. MERCK & CO., INC.: Crixivan® (indinavir sulfate) capsules prescribing information. Merck & Co., Inc. Rahway (NJ) USA (1996).
43. VAN HEESWIJK RP, VELDKAMP AI, HOETELMANS RM et al.: The steady-state plasma pharmacokinetics of indinavir alone and in combination with a low dose of ritonavir in twice daily dosing regimens in HIV-1-infected individuals. AIDS (1999) 13(14):F95-F99.