Current status and future prospects of therapeutic drug monitoring and applied clinical pharmacology in antiretroviral therapy

Antiviral Therapy

Volumn 10, Issue 3, 2005, Pages 375-392

  Boffito, Marta ^a,b   Acosta, Edward ^c   Burger, David ^d   Fletcher, Courtney V ^e   Flexner, Charles ^f   Garaffo, Rodolphe ^g   Gatti, Giorgio ^h,i   Kurowski, Michael ^j   Perno, Carlo Federico ^k   Peytavin, Gilles ^l   Regazzi, Mario ^m   Back, David ⁿ  

^a CHELSEA AND WESTMINSTER HOSPITAL   (United Kingdom)

^b UNIVERSITY OF TURIN   (Italy)

^c UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^d RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^e UNIVERSITY OF COLORADO   (United States)

^f JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g PASTEUR HOSPITAL   (France)

^h VERTEX PHARMACEUTICALS   (United States)

ⁱ UNIVERSITY OF GENOA   (Italy)

^j Therapia GmbH   (Germany)

^k UNIVERSITY OF ROME TOR VERGATA   (Italy)

^l BICHAT HOSPITAL   (France)

^m FONDAZIONE IRCCS POLICLINICO SAN MATTEO   (Italy)

ⁿ UNIVERSITY OF LIVERPOOL   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ABACAVIR; AMPRENAVIR; AMPRENAVIR PHOSPHATE; ANTIRETROVIRUS AGENT; ATAZANAVIR; CYCLOSPORIN; DRUG METABOLIZING ENZYME; EFAVIRENZ; ENFUVIRTIDE; IMMUNOSUPPRESSIVE AGENT; INDINAVIR; LAMIVUDINE; LOPINAVIR; NELFINAVIR; NEVIRAPINE; PROTEINASE INHIBITOR; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; SAQUINAVIR; ZIDOVUDINE; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT;

AREA UNDER THE CURVE; CALCULATION; CHILDHOOD DISEASE; CLINICAL PHARMACOLOGY; CLINICAL TRIAL; DIARRHEA; DOSE LIVER FUNCTION RELATION; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG EXPOSURE; DRUG HALF LIFE; DRUG METABOLISM; DRUG MONITORING; DRUG POTENTIATION; DRUG PROTEIN BINDING; DRUG RESISTANCE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; ETHNIC DIFFERENCE; FOOD DRUG INTERACTION; GOOD LABORATORY PRACTICE; HEPATITIS B; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERBILIRUBINEMIA; HYPERLIPIDEMIA; IC 50; INHIBITORY QUOTIENT; LIPODYSTROPHY; LIVER DYSFUNCTION; LIVER TOXICITY; MIXED INFECTION; NEUROTOXICITY; ORGAN TRANSPLANTATION; PATIENT COMPLIANCE; PHARMACOGENETICS; PHARMACOLOGICAL PARAMETERS; PREGNANCY; PRIORITY JOURNAL; REVIEW; SEX DIFFERENCE; VIROLOGY; VIRUS INHIBITION; CHILD; CONFERENCE PAPER; CONSENSUS DEVELOPMENT; ETHNIC GROUP; FEMALE; LIVER FAILURE; MALE; PROTEIN BINDING; TRANSPLANTATION;

ANTI-HIV AGENTS; CHILD; DRUG MONITORING; ETHNIC GROUPS; FEMALE; HIV INFECTIONS; HUMANS; LIVER FAILURE; MALE; PATIENT COMPLIANCE; PREGNANCY; PROTEIN BINDING; SEX FACTORS; TRANSPLANTATION;

EID: 20444506418     PISSN: 13596535     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (179)

1. Back D, Gatti G, Fletcher C, Garaffo R, Haubrich R, Hoetelmans R, Kurowski M, Luber A, Merry C & Perno CF. Therapeutic drug monitoring in HIV infection: current status and future directions. AIDS 2002; 16(Suppl 1):S5-37.
2. Burger DM, Aarnoutse RE & Hugen PW. Pros and cons of therapeutic drug monitoring of antiretroviral agents. Current Opinion in Infectious Diseases 2002; 15:17-22.
3. Van Heeswijk RPG. Critical issues in TDM of antiretroviral drugs. Therapeutic Drug Monitoring 2002; 24:323-331.
4. Acosta EP & Gerber JG. Position paper on TDM of antiretroviral agents. AIDS Research & Human Retroviruses 2002; 18:825-834.
5. Aarnoutse RE, Schapiro JM, Boucher CA, Hekster YA & Burger DM. Therapeutic drug monitoring: an aid to optimising response to antiretroviral drugs? Drugs 2003; 63:741-753.
6. Kappelhoff BS, Crommentuyn KM, de Maat MM, Mulder JW, Huitema AD & Beijnen JH. Practical guidelines to interpret plasma concentrations of antiretroviral drugs. Clinical Pharmacokinetics 2004; 43:845-853.
7. Yeni PG, Hammer SM, Hirsch MS, Saag MS, Schlechter M, Carpenter CC, Fischl MA, Gatell JM, Gazzard BG, Jacobsen DM, Katzenstein DA, Montaner JS, Richman DD, Schooley RT, Thompson MA, Vella S & Volberding PA. Treatment for adult HIV infection: 2004 recommendations of the International AIDS Society-USA Panel. Journal of the American Medical Association 2004; 292:251-265.
8. Pozniak A, Gazzard B, Anderson J, Babiker A, Churchill D, Collins S, Fisher M, Johnson M, Khoo S, Leen C, Loveday C, Moyle G, Nelson M, Peter B, Phillips A, Pillay D, Wilkins E, Williams I & Youle M; BHIVA Writing Committee BHIVA Executive Committee. British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy. HIV Medicine 2003; 4(Suppl 1):1-41.
9. Nederlandse Vereniging van AIDS Behandelaren. NVAB/Dutch Association of Physicians in AIDS. www.NVAB.org. Accessed November 2004.
10. Recommandations du Groupe d'Experts. Rapport 2000 sous la direction du Pr JF Delfraissy. Prise en Charge Thérapeutique des Personnes Infecté par le VIH. 2004. Paris: Medecine-Sciences, Flammarion.
11. Italian Ministry of Health. Aggiornamento in Tema di Terapia Antirrtrovirale. December 2003. www.ministerosalute.it. Accessed October 2004.
12. Durant J, Clevenbergh P, Garraffo R, Halfon P, Icard S, Del Giudice P, Montagne N, Schapiro JM & Dellamonica P. Importance of protease inhibitor plasma levels in HIV-infected patients treated with genotypic-guided therapy: pharmacological data from the Viradapt Study. AIDS 2000; 14:1333-1339.
13. Marzolini C, Telenti A, Decosterd LA, Greub G, Biollaz J & Buclin T. Efavirenz plasma levels can predict treatment failure and central nervous system side effects in HIV-1-infected patients. AIDS 2001; 15:71-75.
14. Fletcher CV, Anderson PL, Kakuda TN, Schacker TW, Henry K, Gross CR & Brundage RC. Concentration-controlled compared with conventional antiretroviral therapy for HIV infection. AIDS 2002; 16:551-560.
15. Burger D, Hugen P, Reiss P, Gyssens I, Schneider M, Kroon F, Schreij G, Brinkman K, Richter C, Prins J, Aarnoutse R & Lange J; ATHENA Cohort Study Group. Therapeutic drug monitoring of nelfinavir and indinavir in treatment-naive HIV-1-infected individuals. AIDS 2003; 17:1157-1165.
16. Veldkamp AI, Weverling GJ, Lange JM, Montaner JS, Reiss P, Cooper DA, Vella S, Hall D, Beijnen JH & Hoetelmans RM. High exposure to nevirapine in plasma is associated with an improved virological response in HIV-1-infected individuals. AIDS 2001; 15:1089-1095.
17. Anderson PL, Kakuda TN, Kawle S & Fletcher CV. Antiviral dynamics and sex differences of zidovudine and lamivudine triphosphate concentrations in HIV-infected individuals. AIDS 2003; 17:2159-2168.
18. Burger DM, Hoetelmans RM, Hugen PW, Mulder JW, Meenhorst PL, Koopmans PP, Brinkman K, Keuter M, Dolmans W & Hekster YA. Low plasma concentrations of indinavir are related to virological treatment failure in HIV-1-infected patients on indinavir-containing triple therapy. Antiviral Therapy 1998; 3:215-220.
19. Gieschke R, Fotteler B, Buss N & Steimer JL. Relationships between exposure to saquinavir monotherapy and antiviral response in HIV-positive patients. Clinical Pharmacokinetics 1999; 37:75-86.
20. Chan S, Zhang M, Pithavala Y, Kerr B & Knowles M. Potential early predictors of long term virologic response to nelfinavir mesylate (Viracept®): plasma drug concentration, baseline viral load, and initial 4-week change in viral load. 38th Interscience Conference on Antimicrobial Agents & Chemotherapy. 24-27 September 1998, San Diego, CA, USA. Abstract A-11.
21. Hoetelmans RM, Reijers MH, Weverling GJ, ten Kate RW, Wit FW, Mulder JW, Weigel HM, Frissen PH, Roos M, Jurriaans S, Schuitemaker H, de Wolf F, Beijnen JH & Lange JM. The effect of plasma drug concentrations on HIV-1 clearance rate during quadruple drug therapy. AIDS 1998; 12:F111-F115.
22. Burger D, Boyd M, Duncombe C, Felderhof M, Mahanontharit A, Ruxrungtham K, Ubolyam S, Stek M, Cooper D, Lange J, Phanupak P & Reiss P. Pharmacokinetics and pharmacodynamics of indinavir with or without low-dose ritonavir in HIV-infected Thai patients. Journal of Antimicrobial Chemotherapy 2003; 51:1231-1238.
23. Hugen PW, Burger DM, Aarnoutse RE, Baede PA, Nieuwkerk PT, Koopmans PP & Hekster YA. Therapeutic drug monitoring of HIV-protease inhibitors to assess noncompliance. Therapeutic Drug Monitoring 2002; 24:579-587.
24. Descamps D, Flandre P, Calvez V, Peytavin G, Meiffredy V, Collin G, Delaugerre C, Robert-Delmas S, Bazin B, Aboulker JP, Pialoux G, Raffi F & Brun-Vézinet F. Mechanisms of virologic failure in previously untreated HIV-infected patients from a trial of induction-maintenance therapy. Trilege (Agence Nationale de Recherches sur le SIDA 072 Study Team). Journal of the American Medical Association 2000; 283:205-211.
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; 13:473-478.
26. Merry C, Barry MG, Mulcahy F, Ryan M, Heavey J, Tjia JF, Gibbons SE, Breckenridge AM & Back DJ. Saquinavir pharmacokinetics alone and in combination with ritonavir in HIV-infected patients. AIDS 1997; 11:F29-F33.
27. Hsu A, Granneman GR, Cao G, Carothers L, Japour A, El-Shourbagy T, Dennis S, Berg J, Erdman K, Leonard JM & Sun E. Pharmacokinetic interaction between ritonavir and indinavir in healthy volunteers. Antimicrobial Agents & Chemotherapy 1998; 42:2784-2791.
28. Sadler BM, Gillotin C, Lou Y, Eron JJ, Lang W, Haubrich R & Stein DS. Pharmacokinetic study of human immunodeficiency virus protease inhibitors used in combination with amprenavir. Antimicrobial Agents & Chemotherapy 2001; 45:3663-3668.
29. Piscitelli SC & Gallicano KD. Interactions among drugs for HIV and opportunistic infections. New England Journal of Medicine 2001; 344:984-996.
30. Moyle GJ & Back D. Principles and practice of HIV-protease inhibitor pharmacoenhancement. HIV Medicine 2001; 2:105-113.
31. Murphy RL, Brun S, Hicks C, Eron JJ, Gulick R, King M, White AC Jr, Benson C, Thompson M, Kessler HA, Hammer S, Bertz R, Hsu A, Japour A & Sun E. 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-F9.
32. Eron J, Bernstein B, King M, Manning L, Bertz R, Beall G, Carpio-Cedraro F, Feinberg J, Horowitz H, Wheeler D, Kessler H, Mildvan D, Ruane P, Yangco B, Renz C, Mayer S & Sun E. Once-daily vs twice-daily Kaletra (lopinavir/ritonavir) in antiretroviral-naive HIV+ patients: 48-week follow-up. 9th Conference on Retroviruses & Opportunistic Infections. 24-28 February 2002, Seattle, WA, USA. Abstract 409.
33. Gathe JC Jr, Ive P, Wood R, Schurmann D, Bellos NC, DeJesus E, Gladysz A, Garris C & Yeo J. SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir/ritonavir versus twice-daily nelfinavir in naive HIV-1-infected patients. AIDS 2004; 18:1529-1537.
34. Gathe J, Podzamczer D, Johnson M, Schwartz R, Yeh V, Travers N, Luff K, Tressler R & Brun S. Once-daily vs. twice-daily lopinavir/ritonavir in antiretroviral naive-patients: 48-week results. 11th Conference on Retroviruses & Opportunistic Infections. 8-11 February 2004, San Francisco, CA, USA. Abstract 507.
35. Gutierrez F, Padilla S, Navarro A, Masia M, Hernandez I, Ramos J, Esteban A & Martin-Hidalgo A. Lopinavir plasma concentrations and changes in lipid levels during salvage therapy with lopinavir/ritonavir-containing regimens. Journal of Acquired Immune Deficiency Syndromes 2003; 33:594-600.
36. Tseng A, Loufty M, Phillips E, Walker S, Rachilis A & Walmsley S. The relationship between lipid elevations and lopinavir (LPV) concentrations in HIV-infected patients on LPV/r-containing salvage regimens. 42nd Interscience Conference on Antimicrobial Agents & Chemotherapy. 27-30 September 2002, San Diego, CA, USA. Abstract H-1916.
37. Gonzalez de Requena D, Blanco F, Garcia-Benayas T, Jimenez-Nacher I, Gonzalez-Lahoz J & Soriano V. Correlation between lopinavir plasma levels and lipid abnormalities in patients taking lopinavir/ritonavir. AIDS Patient Care STDS 2003; 17:443-445.
38. Boffito M, Bonora S, Sinicco A, Raiteri R, Hoggard PG, Khoo SH, Back DJ & Di Perri G. Lopinavir plasma concentrations and lipid elevation patterns in patients on lopinavir/ritonavir-containing regimens. 4th International Workshop on Clinical Pharmacology of HIV Therapy. 27-29 March 2003, Cannes, France. Abstract 4.4.
39. Torti C, Quiros-Roldan E, Regazzi-Bonora M, De Luca A, Lo Caputo S, Di Giambenedetto S, Patroni A, Villani P, Micheli V & Carosi G; Resistance and Dosage Adapted Regimens Study Group of the MASTER Cohort. Lipid abnormalities in HIV-infected patients are not correlated with lopinavir plasma concentrations. Journal of Acquired Immune Deficiency Syndromes 2004; 35:324-326.
40. Best B, May S, Witt M, Kemper C, Larsen R, Diamond C, Heseltine P, He F, Capparelli E, McCutchan A, Haubrich R & the California Collaborative Treatment Group (CCTG). Relationship between lopinavir concentration and changes in lipid levels at 24 weeks. 11th Conference on Retroviruses & Opportunistic Infections. 8-11 February 2004, San Francisco, CA, USA. Abstract 613.
41. Clevenbergh P, Garraffo R & Dellamonica P. Impact of various antiretroviral drugs and their plasma concentrations on plasma lipids in heavily pretreated HIV-infected patients. HIV Clinical Trials 2003; 4:330-336.
42. Reyataz® (atazanavir). Summary of Product Characteristics. July 2004. Bristol Meyer Squibb Company, Princeton, NJ, USA.
43. Boffito M, Back DJ, Hoggard PG, Caci A, Bonora S, Raiteri R, Sinicco A, Reynolds HE, Khoo S & Di Perri G. Intra-individual variability in lopinavir plasma trough concentrations supports therapeutic drug monitoring. AIDS 2003; 17:1107-1108.
44. Marzolini C, Buclin T, Decosterd LA, Biollaz J & Telenti A. Nelfinavir plasma levels under twice-daily and three-times-daily regimens: high interpatient and low intrapatient variability. Therapeutic Drug Monitoring 2001; 23:394-398.
45. Luber AD, Gunawan S, Lee S, Aquino G, Chaturvedi P & Scarsella A. Serum and plasma drug levels of amprenavir display limited inter- and intra-patient variability. 5th International Congress on Drug Therapy in HIV Infection. 22-26 October 2000, Glasgow, UK. Abstract P267.
46. Almond LM, Boffito M, Hoggard PG, Bonora S, Raiteri R, Reynolds HE, Garazzino S, Sinicco A, Khoo SH, Back DJ & Di Perri G. The relationship between nevirapine plasma concentrations and abnormal liver function tests. AIDS Research & Human Retroviruses 2004; 20:716-722.
47. Almond LM, Boffito M, Hoggard PG, Bonora S, Raiteri R, Sinicco A, Di Perri G & Back DJ. Intra-individual variability in nevirapine plasma concentrations. 9th European AIDS Conference (EACS). 25-29 October 2003, Warsaw, Poland. Abstract 4.2/3.
48. Gonzalez de Requena D, Nunez M, Jimenez-Nacher I & Soriano V. Liver toxicity caused by nevirapine. AIDS 2002; 16:290-291.
49. trough on the time to achieve and time of maintenance of viral suppression in HIV+ patients taking NVP-based regimens. 5th International Workshop on Clinical Pharmacology of HIV Therapy. 1-3 April 2004, Rome, Italy. Abstract 6.10.
50. de Requena DG, Nunez M, Gallego O, Jimenez-Nacher I, Gonzalez-Lahoz J & Soriano V. Does an increase in nevirapine plasma levels cause complete virologic suppression in patients experiencing early virologic failure? HIV Clinical Trials 2002; 3:463-467.
51. Orrell CJ, Geel J, Pitt JA, Van Dyk M & Wood R. Effect of fluconazole on nevirapine pharmacokinetics. 15th International AIDS Conference. 11-16 July 2004, Bangkok, Thailand. Abstract TuPeB4606.
52. Taylor S, Allen S, Fidler S, White D, Gibbons S, Fox J, Clarke J, Weber J, Cane P, Wade A, Smit E & Back D. Stop study: after discontinuation of efavirenz, plasma concentrations may persist for 2 weeks or longer. 11th Conference on Retroviruses & Opportunistic Infections. 8-11 February 2004, San Francisco, CA, USA. Abstract 131.
53. Muro E, Droste J, ter Hofstede H, Bosch M, Dolmans W & Burger D. Nevirapine plasma concentrations are still detectable after more than 2 weeks in the majority of women receiving single-dose NVP: implications for intervention studies. 11th Conference on Retroviruses & Opportunistic Infections. 8-11 February 2004, San Francisco, CA, USA. Abstract 891.
54. Zhang X, Nieforth K, Lang JM, Rouzier-Panis R, Reynes J, Dorr A, Kolis S, Stiles MR, Kinchelow T & Patel IH. Pharmacokinetics of plasma enfuvirtide after subcutaneous administration to patients with human immunodeficiency virus: inverse Gaussian density absorption and 2-compartment disposition. Clinical Pharmacology & Therapeutics 2002; 72:10-19.
55. Zhang X, Buss N, Salgo M & Patel IH. Enfuvirtide pharmacokinetic- pharmacodynamic (PK-PD) relationship. 9th European AIDS Conference (EACS). 25-29 October 2003, Warsaw, Poland. Abstract 4.1/4.
56. trough) in the clinical setting. 5th International Workshop on Clinical Pharmacology of HIV Therapy. 1-3 April 2004, Rome, Italy. Abstract 6.3.
57. Aries SP, Schaaf BM, Wilmsen U, Schuett M & Kurowski M. Routine therapeutic drug monitoring in patients on protease ihnhibitors: impact on therapeutic decisions? AIDS 2000; 14(Suppl 4):S91.
58. Khoo SH, Gibbons SE & Back DJ. Therapeutic drug monitoring as a tool in treating HIV infection. AIDS 2001; 15(Suppl 5):S171-S181.
59. Garaffo R, Lavrut T, Pierre B, Durant J & Dellamonica P. Efavirenz and nevirapine concentration-effect relationships in HIV infected patients pharmacologically followed by routine therapeutic drug monitoring (TDM). 4th International Workshop on Clinical Pharmacology of HIV Therapy. 27-29 April 2003, Cannes, France. Abstract 5.1.
60. Alexander CS, Asselin JJ, Ting LS, Montaner JS, Hogg RS, Yip B, O'Shaughnessy MV & Harrigan PR. Antiretroviral concentrations in untimed plasma samples predict therapy outcome in a population with advanced disease. Journal of Infectious Diseases 2003; 188:541-548.
61. Rendon AL, Nunez M, Gonzalez-Requena D, Jimenez-Nacher I, Gonzalez-Lahoz J & Soriano V. The benefit of treatment interventions driven by therapeutic drug monitoring. 11th Conference on Retroviruses & Opportunistic Infections. 8-11 February, 2004, San Francisco, CA, USA. Abstract 567.
62. Droste JA, Aarnoutse RE, Koopmans PP, Hekster YA & Burger DM. Evaluation of antiretroviral drug measurements by an interlaboratory quality control program. Journal of Acquired Immune Deficiency Syndromes 2003; 32:287-291.
63. Clevenbergh P, Garraffo R, Durant J & Dellamonica P. PharmAdapt: a randomized prospective study to evaluate the benefit of therapeutic monitoring of protease inhibitors: 12 week results. AIDS 2002; 16:2311-2315.
64. Bossi P, Peytavin G, Ait-Mohand H, Delaugerre C, Ktorza N, Paris L, Bonmarchand M, Cacace R, David DJ, Simon A, Lamotte C, Marcelin AG, Calvez V, Bricaire F, Costagliola D & Katlama C. GENOPHAR: a randomized study of plasma drug measurements in association with genotypic resistance testing and expert advice to optimize therapy in patients failing antiretroviral therapy. HIV Medicine 2004; 5:352-359.
65. Baxter JD, Merigan TC, Wentworth DN, Neaton JD, Hoover ML, Hoetelmans RM, Piscitelli SC, Verbiest WH & Mayers DL; CPCRA 046 Study Team for the Terry Beirn Community Programs for Clinical Research on AIDS. Both baseline HIV-1 drug resistance and antiretroviral drug levels are associated with short-term virologic responses to salvage therapy. AIDS 2002; 16:1131-1138.
66. Anderson PL, Brundage RC, Bushman L, Kakuda TN, Remmel RP & Fletcher CV. Indinavir plasma protein binding in HIV-1-infected adults. AIDS 2000; 14:2293-2297.
67. Lexiva® (fosamprenavir). Summary of Product Characteristics. May 2004. GlaxoSmithKline, Research Triangle Park, NC, USA.
68. Bilello JA, Bilello PA, Stellrecht K, Leonard J, Norbeck DW, Kempf DJ, Robins T & Drusano GL. Human serum alpha 1 acid glycoprotein reduces uptake, intracellular concentration, and antiviral activity of A-80987, an inhibitor of the human immunodeficiency virus type 1 protease. Antimicrobial Agents & Chemotherapy 1996; 40:1491-1497.
69. Boffito M, Back DJ, Blaschke TF, Rowland M, Bertz RJ, Gerber JG & Miller V. Protein binding in antiretroviral therapies. AIDS Research & Human Retroviruses 2003; 19:825-835.
70. Boffito M, Hoggard PG, Reynolds HE, Bonora S, Meaden ER, Sinicco A, Di Perri G & Back DJ. The unbound percentage of saquinavir and indinavir remains constant throughout the dosing interval in HIV positive subjects. British Journal of Clinical Pharmacology 2002; 54:262-268.
71. Boffito M, Hoggard PG, Lindup WE, Bonora S, Sinicco A, Khoo SH, Di Perri G & Back DJ. Lopinavir protein binding in vivo through the 12-hour dosing interval. Therapeutic Drug Monitoring 2004; 26:35-39.
72. Herforth C, Stone JA, Jayewardene AL, Blaschke TF, Fang F, Motoya T & Aweeka FT. Determination of nelfinavir free drug concentrations in plasma by equilibrium dialysis and liquid chromatography/tandem mass spectrometry: important factors for method optimization. European Journal of Pharmaceutical Sciences 2002; 15:185-195.
73. Liechty C, Alexander C, Harrigan R, Guzman D, Charlebois ED, Moss AR & Bangsberg DR. Are random antiretroviral drug levels associated with objectively measured adherence behaviour? 10th Conference on Retroviruses & Opportunistic Infections. 10-14 February 2003, Boston, MA, USA. Abstract 529.
74. Brundage RC, Yong FH, Fenton T, Spector SA, Starr SE & Fletcher CV. Intrapatient variability of efavirenz concentrations as a predictor of virologic response to antiretroviral therapy. Antimicrobial Agents & Chemotherapy 2004; 48:979-984.
75. Alcoba M, Cuevas MJ, Perez-Simon MR, Mostaza JL, Ortega L, Ortiz de Urbina J, Carro JA, Raya C, Abad M & Martin V; HAART Adherence Working Group for the Province of Leon, Spain. Assessment of adherence to triple antiretroviral treatment including indinavir: role of the determination of plasma levels of indinavir. Journal of Acquired Immune Deficiency Syndromes 2003; 33:253-258.
76. Yasuda J, Miller C, Little S, Currier J, Forthal D, Kemper C, Beall G, Capparelli E, McCutchan J & Haubrich R. Correlation between repeated measures of plasma concentrations of protease inhibitors, medication adherence, and virologic outcome in HIV-infected patients. 42nd Interscience Conference on Antimicrobial Agents & Chemotherapy. 27-30 September 2002, San Diego, CA, USA. Abstract H-1706.
77. Kempf D, Hsu A, Isaacson J, Jiang P, Brun S, Renz C, Granneman GR & Sun E. Evaluation of the inhibitory quotient as pharmacodynamic predictor of the virologic response to protease inhibitor therapy. 2nd International Workshop on Clinical Pharmacology of HIV Therapy. 2-4 April 2004, Noordwijk, the Netherlands. Abstract 7.3.
78. Fletcher CV, Anderson L, Kakuda TN, Hellmann N, Wynn HE & Brundage RC. A novel approach to integrate pharmacologic and virologic characteristics: an in vivo potency (IVP) index for antiretroviral agents. 8th Conference on Retroviruses & Opportunistic Infections. 4-8 February 2001, Chicago, IL, USA. Abstract 732.
79. Bertz R, Li J, King M, Kempf D, Podzamczer D, Flexner C, Katlama C, Havlir DV, Letendre S, Eron J, Weiss L, Gatell J, Simon A, Robinson K & Brun S. Lopinavir inhibitory quotient predicts virologic response in highly antiretroviral-experienced patients receiving high-dose lopinavir/ritonavir. 11th Conference on Retroviruses & Opportunistic Infections. 8-11 February 2004, San Francisco, CA, USA. Abstract 134.
80. 50) as predictor of virological response. AIDS 2003; 17:262-264.
81. Gonzalez de Requena D, Gallego O, Valer L, Jimenez-Nacher I & Soriano V. Prediction of virological response to lopinavir/ritonavir using the genotypic inhibitory quotient. AIDS Research & Human Retroviruses 2004; 20:275-278.
82. Barrios A, Rendón A, Ríos P, Martin-Carbonero L, Gonzalez de Requena D, Gallego O, Valer L, Maida I, Jimenez-Nacher I, Gonzalez-Lanoz J & Soriano V. Atazanavir plasma levels associated with efficacy and safety in protease inhibitor-experienced HIV-infected patients. 11th Conference on Retroviruses & Opportunistic Infections. 8-11 February 2004, San Francisco, CA, USA. Abstract 606.
83. Castagna A, Danise A, Hasson H, Boeri E, Lazzarin A, Peeters M, Piscitelli S & Hoetelmans R. The normalized inhibitory quotient (NIQ) of lopinavir is predictive of viral load response over 48 weeks in a cohort of highly experienced HIV-1-infected individuals. 9th Conference on Retroviruses & Opportunistic Infections. 24-28 February 2002, Seattle, WA, USA. Abstract 128.
84. De Luca A, Baldini F, Cingolani A, Di Giambenedetto S, Hoetelmans RM & Cauda R. Deep salvage with amprenavir and lopinavir/ritonavir: correlation of pharmacokinetics and drug resistance with pharmacodynamics. Journal of Acquired Immune Deficiency Syndromes 2004; 35:359-366.
85. Marcelin AG, Lamotte C, Delaugerre C, Ktorza N, Ait Mohand H, Cacace R, Bonmarchand M, Wirden M, Simon A, Bossi P, Bricaire F, Costagliola D, Katlama C, Peytavin G & Calvez V; Genophar Study Group. Genotypic inhibitory quotient as predictor of virological response to ritonavir-amprenavir in human immunodeficiency virus type 1 protease inhibitor-experienced patients. Antimicrobial Agents & Chemotherapy 2003; 47:594-600.
86. Cable A, Lamotte C, Dos Santos G, Abel A, Cesaire R & Peytavin G. Therapeutic drug monitoring (TDM) of lopinavir/ritonavir (LPV/r) combination in Caribbean HIV infected patients. 5th International Workshop on Clinical Pharmacology of HIV Therapy. 1-3 April 2004, Rome, Italy. Abstract 1.2.
87. Stazewski S, Dauer B, Carlebach A, Mosch M, Gute P, Klauke S, Kurowski M & von Hentig N. The LOPSAQ Study: 12-hour pharmacokinetic analysis of HIV+ patients treated with the salvage regimen lopinavir (LPV/r) plus saquinavir (SQV) without any additional antiretroviral (ART) therapy. 5th International Workshop on Clinical Pharmacology of HIV Therapy. 1-3 April 2004, Rome, Italy. Abstract 6.4.
88. Hirsch MS, Brun-Vézinet F, Clotet B, Conway B, Kuritzkes DR, D'Aquila RT, Demeter LM, Hammer SM, Johnson VA, Loveday C, Mellors JW, Jacobsen DM & Richman DD. Antiretroviral drug resistance testing in adults infected with human immunodeficiency virus type 1: 2003 recommendations of an International AIDS Society-USA Panel. Clinical Infectious Diseases 2003; 37:113-128.
89. Cohen CJ, Hunt S, Sension M, Farthing C, Conant M, Jacobson S, Nadler J, Verbiest W, Hertogs K, Ames M, Rinehart AR & Graham NM; VIRA3001 Study Team. A randomized trial assessing the impact of phenotypic resistance testing on antiretroviral therapy. AIDS 2002; 16:579-588.
90. Meynard JL, Vray M, Morand-Joubert L, Race E, Descamps D, Peytavin G, Matheron S, Lamotte C, Guiramand S, Costagliola D, Brun-Vézinet F, Clavel F & Girard PM; Narval Trial Group. Phenotypic or genotypic resistance testing for choosing antiretroviral therapy after treatment failure: a randomized trial. AIDS 2002; 16:727-736.
91. Tural C, Ruiz L, Holtzer C, Schapiro J, Viciana P, Gonzalez J, Domingo P, Boucher C, Rey-Joly C & Clotet B; Havana Study Group. Clinical utility or HIV-1 genotyping and expert advice: the Havana trial. AIDS 2002; 16:209-218.
92. Cingolani A, Antinori A, Rizzo MG, Murri R, Ammassari A, Baldini F, Di Giambenedetto S, Cauda R & De Luca A. Usefulness of monitoring HIV drug resistance and adherence in individuals failing highly active antiretroviral therapy: a randomized study (ARGENTA). AIDS 2002; 16:369-379.
93. Haubrich R & Demeter L. International perspectives on antiretroviral resistance. Clinical utility of resistance testing: retrospective and prospective data supporting use and current recommendations. Journal of Acquired Immune Deficiency Syndromes 2001; 26(Suppl 1):S51-S59.
94. Vray M, Meynard JL, Dalban C, Morand-Joubert L, Clavel F, Brun-Vézinet F, Peytavin G, Costagliola D & Girard PM; Narval Trial Group. Predictors of the virological response to a change in the antiretroviral treatment regimen in HIV-1-infected patients enrolled in a randomized trial comparing genotyping, phenotyping and standard of care (Narval trial, ANRS 088). Antiviral Therapy 2003; 8:427-434.
95. Elston R, Randall S, Myers R, Maguire M, Rakik A, Ait-Khaled M, Steirr D & Snowden W. Plasma trough levels correlate with distinct genetic mechanisms during the development of amprenavir resistance. 8th Conference on Retroviruses & Opportunistic Infections. 4-8 February 2001, Chicago, IL, USA. Abstract 465.
96. DeJesus E, LaMarca A, Sension M, Beltran C & Yeni P. 24-week efficacy & safety data of 908/r vs LPV/r in PI experienced subjects. 10th Conference on Retroviruses & Opportunistic Infections. 10-14 February 2003, Boston, MA, USA. Abstract 178.
97. 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. Journal of Infectious Diseases 2000; 182:758-765.
98. Gatti G, Di Biagio A, Casazza R, De Pascalis C, Bassetti M, Cruciani M, Vella S & Bassetti D. The relationship between ritonavir plasma levels and side-effects: implications for therapeutic drug monitoring. AIDS 1999; 13:2083-2089.
99. Wood R, Arasteh K, Pollard R, Kaur P, Nadarer O & Wire B. GW433908, a novel prodrug of the HIV protease inhibitor (PI) amprenavir (APV): safety, efficacy, and pharmacokinetics (PK) (APV20001). 8th Conference on Retroviruses & Opportunistic Infections. 4-8 February 2001, Chicago, IL, USA. Abstract 333.
100. Kempf DJ, King MS, Bernstein B, Cernohous P, Bauer E, Moseley J, Gu K, Hsu A, Brun S & Sun E. Incidence of resistance in a double-blind study comparing lopinavir/ritonavir plus stavudine and lamivudine to nelfinavir plus stavudine and lamivudine. Journal of Infectious Diseases 2004; 189:51-60.
101. MacManus S, Yates PJ, Elston RC, White S, Richards N & Snowden W. GW433908/ritonavir once daily in antiretroviral therapy-naive HIV-infected patients: absence of protease resistance at 48 weeks. AIDS 2004; 18:651-655.
102. Colonno RJ, Thiry A, Limoli K & Parkin N. Activities of atazanavir (BMS-232632) against a large panel of human immunodeficiency virus type 1 clinical isolates resistant to one or more approved protease inhibitors. Antimicrobial Agents & Chemotherapy 2003; 47:1324-1333.
103. Aceti A, Pasquazzi C, Zechini B & de Bac C; LIVER-HAART Group. Hepatotoxicity development during antiretroviral therapy containing protease inhibitors in patients with HIV: the role of hepatitis B and C virus infection. Journal of Acquired Immune Deficiency Syndromes 2002; 29:41-48.
104. Rodriguez-French A, Boghossian J, Gray GE, Nadler JP, Quinones AR, Sepulveda GE, Millard JM & Wannamaker PG. The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of GW433908 versus nelfinavir in antiretroviral therapy-naive HIV-1-infected patients. Journal of Acquired Immune Deficiency Syndromes 2004; 35:22-32.
105. Nadler J, Rodriguez-French A, Millard J & Wannamaker P. The NEAT study: GW433908 efficacy and safety in ART-naive subjects, final 48-week analysis. 10th Conference on Retroviruses & Opportunistic Infections. 10-14 February 2003, Boston, MA, USA. Abstract 177.
106. Reijers MH, Weigel HM, Hart AA, Ten Kate RW, Mulder JW, Reiss P, Schuitemaker H, Hoetelmans RM, Weverling GJ & Lange JM. Toxicity and drug exposure in a quadruple drug regimen in HIV-1 infected patients participating in the ADAM study. AIDS 2000; 14:59-67.
107. Imperiale M, Lanes S, Stern J, Love J, Robinson P & Mayers D. Target: incidence of elevated ALT/AST with HAART in a large observational cohort. 6th International Congress on Drug Therapy in HIV Infection. 17-21 November 2002, Glasgow, UK. Abstract P150.
108. Sulkowski MS, Thomas DL, Chaisson RE & Moore RD. Hepatotoxicity associated with antiretroviral therapy in adults infected with human immunodeficiency virus and the role of hepatitis C or B virus infection. Journal of the American Medical Association 2000; 283:74-80.
109. Dieterich DT, Fischl M & Sepulveda G. The safety/efficacy of protease inhibitors (PIs) in hepatitis C (HCV) co-infection patients. 43rd Interscience Conference on Antimicrobial Agents & Chemotherapy. 14-17 September 2003, Chicago, IL, USA. Abstract H-831.
110. Regazzi M, Villani P, Zucchi P, Cusato M, Sighinolfi L, Catania A, Guaraldi G, Calzetti C, Giacomazzi D, Stoppini L, Rossi MC, Castelli P, Palvarini L & Maserati R. Clinical pharmacokinetics of nelfinavir and its metabolite M8 in HIV/HCV co-infected patients with and without cirrhosis. 4th International Workshop on Clinical Pharmacology of HIV Therapy. 27-29 March 2003, Cannes, France. Abstract 3.5.
111. Maserati R, Zucchi P, Briganti E, Roda R, Sacchelli L, Gatti F, Delle Foglie P, Nardini G, Fabris P, Mori F, Castelli P, Testa L, Villani P, Ravasi G, Cusato M & Regazzi MB. Nelfinavir pharmacokinetics (PK) in HIV-HCV coinfected patients with cirrhosis. 5th International Workshop on Clinical Pharmacology of HIV Therapy. 1-3 April 2003, Rome, Italy. Abstract 3.5.
112. Veronese L, Rautaureau J, Sadler BM, Gillotin C, Petite JP, Pillegand B, Delvaux M, Masliah C, Fosse S, Lou Y & Stein DS. Single-dose pharmacokinetics of amprenavir, a human immunodeficiency virus type 1 protease inhibitor, in subjects with normal or impaired hepatic function. Antimicrobial Agents & Chemotherapy 2000; 44:821-826.
113. Malavaud B, Dinh B, Bonnet E, Izopet J, Payen JL & Marchou B. Increased incidence of indinavir nephrolithiasis in patients with hepatitis B or C virus infection. Antiviral Therapy 2000; 5:3-5.
114. Bossi P, Peytavin G, Lamotte C, Calvez V, Bricaire F, Costagliola D & Katlama C. High indinavir plasma concentrations in HIV-positive patients co-infected with hepatitis B or C virus treated with low doses of indinavir and
115. Arribas J, Pulido F, Peng JZ, Kemmis S, Li JL, Lorenzo A, Cepeda C, Reisch T, Moseley J, Grebner K, Cabanillas JA, Da Silva B, Bernstein B, Chiu YL & Bertz R. Evaluation of multiple-dose pharmacokinetics of lopinavir/ritonavir (LPV/R) in HIV and HCV coinfected subjects with mild or moderate hepatic insufficiency. 9th European AIDS Conference. 25-29 October 2003, Warsaw, Poland. Abstract F2-F6.
116. da Silva B, King M, Cernohous P & Brun S. Lopinavir/ritonavir (LPV/r) safety, tolerability and efficacy in hepatitis C and/or hepatitis B-infected patients: review of clinical trials. 15th International AIDS Conference. 11-16 July 2004, Bangkok, Thailand. Abstract MoPeB3285.
117. Meynard JL, Lacombe K, Poirier JM, Boudraa C, Morand-Joubert L & Girard PM. Influence of HCV or HBV infection on efavirenz plasma concentrations in HIV-infected patients. 11th Conference on Retroviruses & Opportunistic Infections. 8-11 February 2004, San Francisco, CA, USA. Abstract 837.
118. Sarasa M, Miro JM, Knobel H, Mahillo B, Domingo P, Rivero A, Ribera E, Gonzalez J, Sanz J, Gonzalez A, Blanco JL, Boix V, Force L, Dalmau D, Libre JM, Lopez Y, Mallolas J, Carne X, Gatell JM & the Previhne-2 Study Group. Nevirapine plasma levels at two weeks neither predicts nevirapine-associated rash nor liver toxicity. 5th International Workshop on Clinical Pharmacology of HIV Therapy. 1-3 April 2003, Rome, Italy. Abstract 6.5.
119. Lamson M, Maldonado S, Hutman H, MacGregor T, McDonough M, Robinson P & Nusrat R. The effects of underlying renal or hepatic dysfunction on the pharmacokinetics of nevirapine (viramune). 13th International AIDS Conference. 9-14 July 2000, Durban, South Africa. Abstract TuPeB3301.
120. Bergshoeff AS, Fraaij PL, van Rossum AM, Wolfs TF, Geelen SP, de Groot R & Burger DM. Pharmacokinetics of nelfinavir in children: influencing factors and dose implications. Antiviral Therapy 2003; 8:215-222.
121. van Rossum AM, Bergshoeff AS, Fraaij PL, Hugen PW, Hartwig NG, Geelen SP, Wolfs TF, Weemaes CM, De Groot R & Burger DM. Therapeutic drug monitoring of indinavir and nelfinavir to assess adherence to therapy in human immunodeficiency virus-infected children. Pediatric Infectious Disease Journal 2002; 21:743-747.
122. Fletcher CV, Brundage RC, Remmel RP, Page LM, Weller D, Calles NR, Simon C & Kline MW. Pharmacologic characteristics of indinavir, didanosine, and stavudine in human immunodeficiency virus-infected children receiving combination therapy. Antimicrobial Agents & Chemotherapy 2000; 44:1029-1034.
123. Gatti G, Castelli-Gattinara G, Cruciani M, Bernardi S, De Pascalis CR, Pontali E, Papa L, Miletich F & Bassetti D. Pharmacokinetics and pharmacodynamics of nelfinavir administered twice or thrice daily to human immunodeficiency virus type 1-infected children. Clinical Infectious Diseases 2003; 36:1476-1482.
124. Floren LC, Wiznia A, Hayashi S, Jayewardene A, Stanley K, Johnson G, Nachman S, Krogstad P & Aweeka FT; Pediatric AIDS Clinical Trials Group 377 Protocol Team. Nelfinavir pharmacokinetics in stable human immunodeficiency virus-positive children: Pediatric AIDS Clinical Trials Group Protocol 377. Pediatrics 2003; 112:E220-E227.
125. Viracept® (nelfinavir). Summary of Product Characteristics. April 2004. Agouron Pharmaceuticals, Inc, La Jolla, CA, USA.
126. Saez-Llorens X, Violari A, Deetz CO, Rode RA, Gomez P, Handelsman E, Pelton S, Ramilo O, Cahn P, Chadwick E, Allen U, Arpadi S, Castrejon MM, Heuser RS, Kempf DJ, Bertz RJ, Hsu AF, Bernstein B, Renz CL & Sun E. Forty-eight-week evaluation of lopinavir/ritonavir, a new protease inhibitor, in human immunodeficiency virus-infected children. Pediatric Infectious Disease Journal 2003; 22:216-224.
127. Grub S, Delora P, Ludin E, Duff F, Fletcher CV, Brundage RC, Kline MW, Calles NR, Schwarzwald H & Jorga K. Pharmacokinetics and pharmacodynamics of saquinavir in pediatric patients with human immunodeficiency virus infection. Clinical Pharmacology & Therapeutics 2002; 71:122-130.
128. Kim RB. Pharmacogenetics of CYP enzymes and drug transporters: remarkable recent advances. Advanced Drug Delivery Reviews 2002; 54:1241-1242.
129. Hesselink DA, van Schaik RH, van der Heiden IP, van der Werf M, Gregoor PJ, Lindemans J, Weimar W & van Gelder T. Genetic polymorphisms of the CYP3A4, CYP3A5, and MDR-1 genes and pharmacokinetics of the calcineurin inhibitors cyclosporine and tacrolimus. Clinical Pharmacology & Therapeutics 2003; 74:245-254.
130. Tang K, Ngoi SM, Gwee PC, Chua JM, Lee EJ, Chong SS & Lee CG. Distinct haplotype profiles and strong linkage disequilibrium at the MDR1 multidrug transporter gene locus in three ethnic Asian populations. Pharmacogenetics 2002; 12:437-450.
131. Kim RB, Leake BF, Choo EF, Dresser GK, Kubba SV, Schwarz UI, Taylor A, Xie HG, McKinsey J, Zhou S, Lan LB, Schuetz JD, Schuetz EG & Wilkinson GR. Identification of functionally variant MDR1 alleles among European Americans and African Americans. Clinical Pharmacology & Therapeutics 2001; 70:189-199.
132. Fellay J, Marzolini C, Meaden ER, Back DJ, Buclin T, Chave JP, Decosterd LA, Furrer H, Opravil M, Pantaleo G, Retelska D, Ruiz L, Schinkel AH, Vernazza P, Eap CB & Telenti A; Swiss HIV Cohort Study. Response to antiretroviral treatment in HIV-1-infected individuals with allelic variants of the multidrug resistance transporter 1: a pharmacogenetics study. Lancet 2002; 359:30-36.
133. Anderson P, Lamba J, Schuetz E & Fletcher CV. CYP 3A5 and MDR1 (P-gp) polymorphism in HIV infected adults: association with indinavir concentrations and antiviral effects. 11th Conference on Retroviruses & Opportunistic Infections. 8-11 February 2004, San Francisco, CA, USA. Abstract 619.
134. Owen A, Fox Z, Almond L, Bak Dragsted U, Back D, Youle M, Lundgren J, Khoo S & the MaxCmin1 Steering Comitee. The role of genetic polymorphism of the MDR1 gene in the MaxCmin1 study. 11th Conference on Retroviruses & Opportunistic Infections. 8-11 February 2004, San Francisco, CA, USA. Abstract 619b.
135. Csajka C, Marzolini C, Fattinger K, Decosterd LA, Fellay J, Telenti A, Biollaz J & Buclin T. Population pharmacokinetics and effects of efavirenz in patients with human immunodeficiency virus infection. Clinical Pharmacology & Therapeutics 2003; 73:20-30.
136. Lorber M, Shahar E, Averbuch D, Maayan S, Burk M, Agmon-Levine N & Shapiro JM. Nelfinavir and lopinavir plasma concentrations in HIV infected patients from different origins. 4th International Workshop on Clinical Pharmacology of HIV Therapy. 27-29 March 2003, Cannes, France. Abstract 3.4.
137. Haas DW, Ribaudo HJ, Kim RB, Tierney C, Wilkinson GR, Gulick RM, Clifford DB, Hulgan T, Marzolini C & Acosta EP. Pharmacogenetics of efavirenz and central nervous system side effects: an Adult AIDS Clinical Trials Group study. AIDS 2004; 18:2391-2400.
138. Hutson WR, Roehrkasse RL & Wald A. Influence of gender and menopause on gastric emptying and motility. Gastroenterology 1989; 96:11-17.
139. Gandhi M, Aweeka F, Greenblatt RM & Blaschke TF. Sex differences in pharmacokinetics and pharmacodynamics. Annual Review of Pharmacology & Toxicology 2004; 44:499-523.
140. Cummins CL, Wu CY & Benet LZ. Sex-related differences in the clearance of cytochrome P450 3A4 substrates may be caused by P-glycoprotein. Clinical Pharmacology & Therapeutics 2002; 72:474-489.
141. Cordaro JA, Morse GD, Bartos L, Gugino LJ, Maliszewski M, Colomaio R, Shelton M, O'Donnell A & Hewitt R. Zidovudine pharmacokinetics in HIV-positive women during different phases of the menstrual cycle. Pharmacotherapy 1993; 13:369-377.
142. Moore AL, Kirk O, Johnson AM, Katlama C, Blaxhult A, Dietrich M, Colebunders R, Chiesi A, Lungren JD & Phillips AN; EuroSIDA group. Virologic, immunologic, and clinical response to highly active antiretroviral therapy: the gender issue revisited. Journal of Acquired Immune Deficiency Syndromes 2003; 32:452-461.
143. Boxwell DE & Styrt BA. Lactic acidosis in patients receiving nucleoside reverse transcriptase inhibitors. 39th Interscience Conference on Antimicrobial Agents & Chemotherapy. 26-29 September 1999, San Francisco, CA, USA. Abstract 1284.
144. Currier JS, Spino C, Grimes J, Wofsy CB, Katzenstein DA, Hughes MD, Hammer SM & Cotton DJ. Differences between women and men in adverse events and CD4+ responses to nucleoside analogue therapy for HIV infection. The Aids Clinical Trials Group 175 Team. Journal of Acquired Immune Deficiency Syndromes 2000; 24:316-324.
145. Bersoff-Matcha SJ, Miller WC, Aberg JA, van Der Horst C, Hamrick Jr HJ, Powderly WG & Mundy LM. Sex differences in nevirapine rash. Clinical Infectious Diseases 2001; 32:124-129.
146. Viramune® [nevirapine]. Summary of Product Characteristics. January 2004. Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA.
147. Lucas GM, Chaisson RE & Moore RD. Highly active antiretroviral therapy in a large urban clinic: risk factors for virologic failure and adverse drug reactions. Annals of Internal Medicine 1999; 131:81-87.
148. La Porte C, Burger D, Gyssens I, Sprenger H, Koopmans P. Gender differences in nevirapine pharmacokinetics, fact or fiction? 4th International Workshop on Clinical Pharmacology of HIV Therapy. 27-29 March 2003, Cannes, France. Abstract 3.1.
149. Regazzi MB, Villani P, Seminari E, Marubbi F, Meneghetti G, Cusato M & Maserati R. Analysis of potential gender differences in nevirapine disposition in HIV-infected patients. 3rd International Workshop on Clinical Pharmacology of HIV Therapy. 11-13 April 2002, Washington, DC, USA. Abstract 4.4.
150. Pfister M, Labbe L, Hammer SM, Mellors J, Bennett KK, Rosenkranz S & Sheiner LB; Adult AIDS Clinical Trial Group Study 398. Population pharmacokinetics and pharmacodynamics of efavirenz, nelfinavir, and indinavir: Adult AIDS Clinical Trial Group Study 398. Antimicrobial Agents & Chemotherapy 2003; 47:130-137.
151. Ribaudo H, Clifford D, Gulick D, Shikuma C, Klingman K, Snyder S & Acosta E. Relationships between efavirenz pharmacokinetics, side effects, drug discontinuation, virologic response, and race: results from ACTG A5095/A5097s. 11th Conference on Retroviruses & Opportunistic Infections. 8-11 February 2004, San Francisco, CA, USA. Abstract 132.
152. Fletcher CV, Jiang H, Brundage RC, Acosta EP, Haubrich R, Katzenstein D & Gulick RM. Sex-based differences in saquinavir pharmacology and virologic response in AIDS Clinical Trials Group Study 359. Journal of Infectious Diseases 2004; 189:1176-1184.
153. Burger DM, La Porte CJL, van der Ende ME, Miesen WMAJ & Koopmans PP. Gender-related differences in efavirenz pharmacokinetics. 4th International Workshop on Clinical Pharmacology of HIV Therapy. 27-29 March 2003, Cannes, France. Abstract 3.6.
154. Burger DM, Siebers MC, Hugen PW, Aarnoutse RE, Hekster YA & Koopmans PP. Pharmacokinetic variability caused by gender: do women have higher indinavir exposure than men? Journal of Acquired Immune Deficiency Syndromes 2002; 29:101-102.
155. Cardiello PG, van Heeswijk RP, Hassink EA, Srasuebkul P, Mahanontharit A, Samor TM, Worarien W, Beijnen JH, Hoetelmans RM, Ruxrungtham K, Cooper DA, Lange JM & Phanuphak P. Simplifying protease inhibitor therapy with once-daily dosing of saquinavir soft-gelatin capsules/ritonavir (1600/100 mg): HIVNAT 001.3 Study. Journal of Acquired Immune Deficiency Syndromes 2002; 29:464-470.
156. Poirier JM, Zouai O, Meynard JL, Lacombe K, Guiard-Schmid JB, Girard PM & Jaillon P. Lack of effect of gender, age, weight and body mass index on trough lopinavir plasma concentrations in HIV-experienced patients treated with Kaletra. 4th International Workshop on Clinical Pharmacology of HIV Therapy. 27-29 March 2003, Cannes, France. Abstract 6.12.
157. Bertz R, Lam W, Hsu A, Granneman GR & Sun E. Effects of gender, race, age & weight on pharmacokinetics of lopinavir after a single dose of Kaletra in healthy adults. 2nd International Workshop on Clinical Pharmacology of HIV Therapy. 2-4 April 2001, Noordwijk, The Netherlands. Abstract 3.11.
158. Gibbons S, Robinson L, Davies G, Back DJ & Khoo SH. Is there evidence for weight-adjusted dosing of Kaletra? 10th Anniversary Conference of the British HIV Association (BHIVA). 15-17 April 2004, Cardiff, UK. Abstract P75.
159. Boffito M, Arnaudo I, Raiteri R, Bonora S, Sinicco A, Di Garbo A, Reynolds HE, Hoggard PG, Back DJ & Di Perri G. Clinical use of lopinavir/ritonavir in a salvage therapy setting: pharmacokinetics and pharmacodynamics. AIDS 2002; 16:2081-2083.
160. Little BB. Pharmacokinetics during pregnancy: evidence-based maternal dose formulation. Obstetrics & Gynecology 1999; 93:858-868.
161. Kosel BW, Beckerman KP, Hayashi S, Homma M & Aweeka FT. Pharmacokinetics of nelfinavir and indinavir in HIV-1-infected pregnant women. AIDS 2003; 17:1195-1199.
162. Bryson Y, Stek A, Mirichnick M, Connor J, Huang S, Hughes M, Mofenson L, Culane M, Snidow J & Gersten M. PACTG 353 A phase I study of safety, pharmacokinetics, and antiviral activity of combination nelfinavir (NFV), ZDV, and 3TC in HIV-infected pregnant women and their infants. 7th Conference on Retroviruses & Opportunistic Infections. 30 January-2 February 2000, San Francisco, CA, USA. Abstract 715.
163. Acosta EP, Bardeguez A, Zorrilla CD, Van Dyke R, Hughes MD, Huang S, Pompeo L, Stek AM, Pitt J, Watts DH, Smith E, Jimenez E & Mofenson L; Pediatric AIDS Clinical Trials Group 386 Protocol Team. Pharmacokinetics of saquinavir plus low-dose ritonavir in human immunodeficiency virus-infected pregnant women. Antimicrobial Agents & Chemotherapy 2004; 48:430-436.
164. Hawkins DA, Khan W, Moyle GJ, Penn Z, Lyall H, Back D & Hill A. Pharmacokinetics (PK), safety, tolerability and efficacy of saquinavir hard-gel capsules/ritonavir (SQV/r) plus 2 nucleosides in HIV-1-infected pregnant women. 15th International AIDS Conference. 11-16 July 2004, Bangkok, Thailand. Abstract ThPeB7064.
165. Stek A, Mirochnick M, Capparelli E, Best B, Burchett SK, Hu C, Gardella J, Elgie C, Schiffhauer J, Smith E, Read J & Tuomala R. Reduced lopinavir exposure during pregnancy: preliminary pharmacokinetic results from PACTG 1026. 15th International AIDS Conference. 11-16 July 2004, Bangkok, Thailand. Abstract LbOrB08.
166. Ragni MV, Belle SH, Im K, Neff G, Roland M, Stock P, Heaton N, Humar A & Fung JF. Survival of human immunodeficiency virus-infected liver transplant recipients. Journal of Infectious Diseases 2003; 188:1412-1420.
167. Roland ME. Solid-organ transplantation in HIV-infected patients in the potent antiretroviral therapy era. Topics in HIV Medicine 2004; 12:73-76.
168. Kaletra® (lopinavir/ritonavir). Summary of Product Characteristics. February 2004. Abbott Laboratories, North Chicago, IL, USA.
169. Brinkman K, Huysmans F & Burger DM. Pharmacokinetic interaction between saquinavir and cyclosporine. Annals of Internal Medicine 1998; 129:914-915.
170. Tseng A, Nguyen ME, Cardella C, Humar A & Conly J. Probable interaction between efavirenz and cyclosporine. AIDS 2002; 16:505-506.
171. Agenerase® (amprenavir). Summary of Product Characteristics. February 2004. GlaxoSmithKline, Research Triangle Park, NC, USA.
172. Crixivan® (indinavir). Summary of Product Characteristics. January 2002. Merck & Co, Whitehouse Station, NJ, USA.
173. Invirase® (saquinavir). Summary of Product Characteristics. September 2004. Roche, Welwyn Garden City, Hertfordshire, UK.
174. de Maat MM, ter Heine R, Mulder JW, Meenhorst PL, Mairuhu AT, van Gorp EC, Huitema AD & Beijnen JH. Incidence and risk factors for nevirapine-associated rash. European Journal of Clinical Pharmacology 2003; 59:457-462.
175. Zhou XJ, Sheiner LB, D'Aquila RT, Hughes MD, Hirsch MS, Fischl MA, Johnson VA, Myers M & Sommadossi JP. Population pharmacokinetics of nevirapine, zidovudine, and didanosine in human immunodeficiency virus-infected patients. The National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group Protocol 241 Investigators. Antimicrobial Agents & Chemotherapy 1999; 43:121-128.
176. Mirochnick M, Fenton T, Gagnier P, Pav J, Gwynne M, Siminski S, Sperling RS, Beckerman K, Jimenez E, Yogev R, Spector SA & Sullivan JL. Pharmacokinetics of nevirapine in human immunodeficiency virus type 1-infected pregnant women and their neonates. Pediatric AIDS Clinical Trials Group Protocol 250 Team. Journal of Infectious Diseases 1998; 178:368-374.
177. Weller S, Radomski KM, Lou Y & Stein DS. Population pharmacokinetics and pharmacodynamic modeling of abacavir (1592U89) from a dose-ranging, double-blind, randomized monotherapy trial with human immunodeficiency virus-infected subjects. Antimicrobial Agents & Chemotherapy 2000; 44:2052-2060.
178. Trout H, Mentre F, Panhard X, Kodjo A, Escaut L, Pernet P, Gobert JG, Vittecoq D, Knellwolf AL, Caulin C & Bergmann JF. Enhanced saquinavir exposure in human immunodeficiency virus type 1-infected patients with diarrhea and/or wasting syndrome. Antimicrobial Agents & Chemotherapy 2004; 48:538-545.
179. Gatti G, De Pascalis CR, De Luca A, Di Biagio A, Borderi M, Maserati R, Bonora S, Calza L, Meraviglia P & Bassetti D. Predictors of amprenavir parameters of drug exposure in heavily pretreateo HIV+ patients. 6th International Congress on Drug Therapy in HIV Infection. 17-21 November 2002, Glasgow, UK. Abstract P165.