Multiple-dose pharmacokinetics of ritonavir in human immunodeficiency virus-infected subjects

Antimicrobial Agents and Chemotherapy

Volumn 41, Issue 5, 1997, Pages 898-905

  Hsu, Ann ^a   Granneman, G Richard ^a   Witt, Galen ^a   Locke, Charles ^a   Denissen, Jon ^a   Molla, Akhteruzzaman ^a   Valdes, Joaquin ^a   Smith, Judy ^a   Erdman, Keith ^a   Lyons, Nick ^a   Niu, Ping ^a   Decourt, Jean Phillipe ^b   Fourtillan, Jean Bernard ^b   Girault, Jacques ^b   Leonard, John M ^a  

^a ABBOTT LABORATORIES   (United States)

^b CEMAF sa   (France)

Author keywords

[No Author keywords available]

Indexed keywords

RITONAVIR; TRIACYLGLYCEROL;

ADULT; ARTICLE; CLINICAL TRIAL; COMPARTMENT MODEL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG HALF LIFE; DRUG METABOLISM; DRUG PROTEIN BINDING; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; ORAL DRUG ADMINISTRATION; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TRIACYLGLYCEROL BLOOD LEVEL;

EID: 0030896237     PISSN: 00664804     EISSN: None     Source Type: Journal    
DOI: 10.1128/aac.41.5.898     Document Type: Article

References (32)

1. Abbott Laboratories. 1996. NORVIR™ pro duct information. Abbott Laboratories, Abbott Park, Ill.
2. Barry, M., and J. Feely. 1990. Enzyme induction and inhibition. Pharmacol. Ther. 48:71-94.
3. Bertz, R. J., G. Cao, J. H. Cavanaugh, A. Hsu, G. R. Granneman, and J. M. Leonard. 1996. Effect of ritonavir on the pharmacokinetic of desipramine, abstr. 2768. In Program and abstracts of the XI International Conference on AIDS.
4. Cato, A., J. H. Cavanaugh, H. Shi, A. Hsu, G. R. Granneman, and J. M. Leonard. 1996. Assessment of multiple doses of ritonavir on the pharmacokinetic of rifabutin, abstr. 2766. In Program and abstracts of the XI International Conference on AIDS.
5. Cato, A., A. Hsu, R. Granneman, J. Leonard, G. Carlson, L. Carothers, and C. Locke. 1995. Assessment of the pharmacokinetic interaction between the HIV-1 protease inhibitor ABT-538 and zidovudine, abstr. 133, p. 211. In Program and abstracts of the 35th Interscience Conference on Antimicrobial Agents and Chemotherapy. American Society for Microbiology, Washington, D.C.
6. Cole, J. W. L., and J. E. Grizzle. 1966. Applications of multivariate analysis of variance to repeated measures experiments. Biometrics 22:810-828.
7. Craig, J. C., I. B. Duncan, D. Hockley, C. Grief, N. A. Roberts, and J. S. Mills. 1991. Antiviral properties of Ro 31-8959, an inhibitor of human immunodeficiency virus (HIV) proteinase. Antiviral Res. 16:295-305.
8. Danner, S. A., A. Carr, J. M. Leonard, L. M. Lehman, F. Gudiol, J. Gonzales, A. Raventos, R. Rubio, E. Bouza, V. Pintade, A. Gil Aguado, J. Garcia de Lomas, R. Delgado, J. C. C. Borleffs, A. Hsu, J. M. Valdes, C. A. B. Boucher, and D. A. Cooper. 1995. Safety, pharmacokinetics, and preliminary efficacy of ritonavir, an inhibitor of HIV-1 protease. A short-term study of the safety, pharmacokinetics, and efficacy of ritonavir, an inhibitor of HIV-1 protease. N. Engl. J. Med. 333:1528-1533.
9. Goldberg, D. M., M. W. Roomi, A. Yu, and D. A. K. Roncari. 1980. Effects of phenobarbital upon triacylglycerol metabolism in the rabbit. Biochem. J. 192:165-175.
10. Ho, D. D., A. U. Neumann, A. S. Perelson, W. Chen, J. M. Leonard, and M. Markowitz. 1995. Rapid turnover of plasma virions and CD-4 lymphocytes in HIV-1 infection. Nature 373:123-126.
11. Hsu, A., G. R. Granneman, K. Marsh, G. Witt, J. Valdes, K. Meyer, K. Erdman, J. F. Denissen, J. P. DeCourt, and J. Leonard. Single-dose pharmacokinetics of ritonavir, an HIV-protease inhibitor. Submitted for publication.
12. Hsu, A., G. R. Granneman, G. Witt, J. H. Cavanaugh, and J. M. Leonard. 1996. Assessment of multiple doses of ritonavir on the pharmacokinetics of theophylline, abstr. 2767. In Program and abstracts of the XI International Conference on AIDS.
13. Hubscher, G. Glyceride metabolism, p. 280-370. In S. J. Wakil (ed.), Lipid metabolism. Academic Press, London, United Kingdom.
14. Kempf, D. J., K. C. Marsh, J. F. Denissen, E. McDonald, S. Vasavanonda, C. A. Flentge, B. E. Green, L. Fino, C. H. Park, X.-P. Kong, N. E. Wideburg, A. Saldivar, L. Ruiz, W. M. Kati, H. L. Sham, T. Robins, K. D. Stewart, A. Hsu, J. J. Platner, J. M. Leonard, and D. W. Norbeck. 1995. ABT-538 is a potent inhibitor of human immunodeficiency virus protease and has high oral bioavailability in humans. Proc. Natl. Acad. Sci. USA 92:2484-2488.
15. 2 symmetric inhibitors of HIV protease. J. Med. Chem. 33:2687-2689.
16. Kohl, N. E., E. A. Emini, W. A. Schleif, L. J. Davis, J. C. Heimbach, R. A. F. Dixon, E. M. Scolnick, and I. S. Sigal. 1988. Active human immunodeficiency virus protease is required for viral infectivity. Proc. Natl. Acad. Sci. USA 85:4686-4690.
17. Kumar, G. I., A. D. Rodrigues, A. M. Buko, and J. F. Denissen. 1996. Cytochromc P450-mediated metabolism of the HIV-1 protease inhibitor ritonavir (ABT-538) in human liver microsomes. J. Pharmacol. Exp. Ther. 277:423-431.
18. Lai, A. A., R. H. Levy, and R. E. Cutler. 1979. Time-course of interaction between carbamazepine and clonazepam in normal man. Clin. Pharmacol. Ther. 24:316-323.
19. Levy, R. H., A. A. Lai, and M. S. Dumain. 1979. Time-dependent kinetic IV: pharmacokinetic theory of enzyme induction. J. Pharm. Sci. 68:398-399.
20. Markowitz, M., M. Saag, W. Powderly, A. M. Hurley, A. Hsu, J. M. Valdes, D. Henry, F. Sattler, A. LaMarca, and J. M. Leonard. 1995. A preliminary study of ritonavir, an inhibitor of HIV-1 protease, to treat HIV-1 infection. 1995. N. Engl. J. Med. 333:1534-1539.
21. Martin, J. V., P. J. Martin, and D. M. Goldberg. 1976. Enzyme induction as a possible cause of increased serum-triglycerides after oral contraceptives. Lancet i:1107-1108.
22. Martin, P. J., R. V. Hague, J. V. Martin, D. R. Cullen, and D. M. Goldberg. 1976. The association between serum triglycerides and gamma glutamyl transpeptidase activity in diabetes mellitus. Clin. Biochem. 9:208-211.
23. Ohnhaus, E. E., A. M. Breckenridge, and B. K. Park. 1989. Urinary excretion of 6-β-hydroxycortisol and the time course measurement of enzyme induction in man. Eur. J. Clin. Pharmacol. 36:39-46.
24. Okey, A. B. 1990. Enzyme induction in the cytochrome P-450 system. Pharmacol. Ther. 45:241-298.
25. Ouellet, D., A. Hsu, G. R. Granneman, G. Carlson, H. Guenther, D. Mukherjee, C. Locke, and J. M. Leonard. 1996. Assessment of the pharmacokinetic interaction between ritonavir (R) and clarithromycin (C). Clin. Pharmacol. Ther. 59:143.
26. Ouellet, D., A. Hsu, J. Qian, J. H. Cavanaugh, J. M. Leonard, and G. R. Granneman. 1996. Effect of ritonavir on the pharmacokinetic of ethinyl estradiol in healthy female volunteers, abstr. 2765. In Program and abstracts of the XI International Conference on AIDS.
27. Perelson, A. S., A. U. Neumann, M. Markowitz, J. M. Leonard, and D. D. Ho. 1996. HIV-1 dynamics in vivo: virion clearance rate, infected cell lifespan, and viral generations. Science 271:1582-1586.
28. Pichard, L., I. Fahre, G. Fahre, J. Domergue, B. Saint Auber, G. Mourad, and P. Maurel. 1990. Cyclosporine A drug interactions: screening for inducers of cytochrome P-450 (cyclosporine A oxidase) in primary cultures of human hepatocytes and in liver microsomes. Drug Metab. Dispos. 18:595-606.
29. Sheiner, L. B., and S. Beal. 1980. Evaluation of methods for estimating population pharmacokinetic parameters. I. Michaelis-Menten model: routine clinical pharmacokinetic data. J. Pharmacokinet. Biopharm. 8:553-571.
30. Tomasselli, A. G., W. J. Howe, T. K. Sawyer, A. Wlodawer, and R. L. Heinrikson. 1991. The complexities of AIDS: an assessment of the HIV protease as a therapeutic target. Chim. Oggi 1991:6-27.
31. Vacca, J. P., B. D. Dorsey, W. A. Schlief, R. B. Levin, S. L. McDaniel, P. L. Darke, J. Zugay, J. C. Quintero, O. M. Blahy, E. Roth, V. V. Sardana, A. J. Schlabach, P. I. Graham, J. H. Condra, L. Gotlib, M. K. Holloway, J. Lin, I.-W. Chen, K. Vastag, D. Ostovic, P. S. Anderson, E. A. Emini, and J. R. Huff. 1994. L-735-524: an orally bioavailable human immunodeficiency virus type I protease inhibitor. Proc. Natl. Acad. Sci. USA 91:4096-4100.
32. Venkatesan, K. 1992. Pharmacokinetic drug interactions with rifampicin. Clin. Pharmacokinet. 22:47-65.