Phase I dose-escalation pharmacokinetics of AZT-P-ddI (IVX-E-59) in patients with human immunodeficiency virus

Journal of Clinical Pharmacology

Volumn 37, Issue 3, 1997, Pages 201-213

  Zhou, Xiao Jian ^a   Squires, Kathleen ^a   Pan Zhou, Xin Ru ^a   Bernhard, Steve ^a   Agrofoglio, Luigi ^a   Kirk, Marion ^a   Duchin, Kenneth L ^a   Sommadossi, Jean Pierre ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

3' AMINO 3' DEOXYTHYMIDINE; 3' AZIDO 3' DEOXYTHYMIDYLYL (5',5') 2',3' DIDEOXYINOSINIC ACID; DIDANOSINE; UNCLASSIFIED DRUG; ZIDOVUDINE DERIVATIVE;

ADULT; ANTIVIRAL ACTIVITY; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SELECTIVITY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INTRAVENOUS DRUG ADMINISTRATION; MALE; ORAL DRUG ADMINISTRATION; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL;

EID: 0030998127     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1002/j.1552-4604.1997.tb04782.x     Document Type: Article

References (39)

1. Fischl MA, Richman DD, Grieco MH, Gottlieb MS, Volberding PA, Laskin OL, et al: The efficacy of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex. N Engl J Med 1987;317:185-191.
2. Kahn JO, Lagakos SW, Richman DD, Cross A, Pettinelli C, Liou SH, et al: A controlled trial comparing continued zidovudine with didanosine in human immunodeficiency virus infection. The NI-AID AIDS Clinical Trials Group. N Engl J Med 1992;327:581-587.
3. Yarchoan R, Perno CF, Thomas RV, Klecker RW, Allain JP, Wills RJ, et al: Phase I studies of 2′,3′-dideoxycytidine in severe human immunodeficiency virus infection as a single agent and alternating with zidovudine (AZT). Lancet 1988;1:76-81.
4. van Leeuwen R, Katlama C, Kitchen V, Boucher CA, Tubiana R, McBride M, et al: Evaluation of safety and efficacy of 3TC (lamivudine) in patients with asymptomatic or mildly symptomatic human immunodeficiency virus infection: a Phase I/II study. J Infect Dis 1995;171:1166-1171.
5. Murray HW, Squires KE, Weiss W, Sledz S, Sacks HS, Hassett J, et al: Stavudine in patients with AIDS and AIDS-related complex: AIDS clinical trials group 089. J Infect Dis 1995;171 (suppl 2):123-130.
6. Sommadossi JP: Nucleoside analogs: similarities and differences. Clin Infect Dis 1993;16(suppl 1):7-15.
7. Schmitt FA, Bigley JW, McKinnis R, Logue PE, Evans RW, Drucker JL, et al: Neuropsychological outcome of zidovudine (AZT) treatment of patients with AIDS and AIDS-related complex. N Engl J Med 1988;319:1573-1578.
8. Richman DD, Fischl MA, Grieco MH, Gottlieb MS, Volberding PA, Laskin OL, et al: The toxicity of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex. N Engl J Med 1987;317:192-197.
9. Richman DD: Zidovudine resistance of human immunodeficiency virus. Rev Infect Dis 1990;12(suppl 5):507-512.
10. Baba M, Pauwels R, Balzarini J, Herdewijn P, De Clercq E, Desmyter J: Ribavirin antagonizes inhibitory effects of pyrimidine 2′,3′-dideoxynucleosides but enhances inhibitory effects of purine 2′,3′-dideoxynucleosides on replication of human immunodeficiency virus in vitro. Antimicrob Agents Chemother 1987; 31:1613-1617.
11. McLeod GX, Hammer SM: Treatment of HIV infection: the antiretroviral nucleoside analogues. Nucleoside analogues: combination therapy. Hosp Pract 1992;27(suppl 2):14-25.
12. Meng TC, Fischl MA, Boota AM, Spector SA, Bennett D, Bassiakos Y, et al: Combination therapy with zidovudine and dideoxycytidine in patients with advanced human immunodeficiency virus infection: a Phase I/II study. Ann Intern Med 1992;116:13-20.
13. Larder BA, Kemp SD, Harrigan PR: Potential mechanism for sustained antiretroviral efficacy of AZT-3TC combination therapy. Science 1995;269:696-699.
14. Busso M, Mian AM, Hahn EF, Resnick L: Nucleotide dimers suppress HIV expression in vitro. AIDS Res Human Retroviruses 1988;4:449-455.
15. Schinazi RF, Sommadossi JP, Saalmann V, Cannon DL, Xie MY, Hart GC, et al: Activities of 3′-azido-3′-deoxythymidine nucleotide dimers in primary lymphocytes infected with human immunodeficiency virus type 1. Antimicrob Agents Chemother 1990;34:1061-1067.
16. IVX-E-59. Investigator's Brochures. Baker Norton Pharmaceuticals. Inc., 1993.
17. Klecker RW Jr, Collins JM, Yarchoan R, Thomas R, Jenkins JF, Broder S, Myers CE: Plasma and cerebrospinal fluid pharmacokinetics of 3′-azido-3′-deoxythymidine: a novel pyrimidine analog with potential application for the treatment of patients with AIDS and related diseases. Clin Pharmacol Ther 1987;41:407-412.
18. Blum MR, Liao S, Good SS, de Miranda P: Pharmacokinetics and bioavailability of zidovudine in humans. Am J Med 1988; 85(suppl 2A):189-194.
19. Stagg MP, Cretton EM, Kidd L, Diasio RB, Sommadossi JP: Clinical pharmacokinetics of 3′-azido-3′-deoxythymidine (zidovudine) and catabolites with formation of a toxic catabolite, 3′-amino-3′-deoxythymidine. Clin Pharmacol Ther 1992;51:668-676.
20. Hartman NR, Yarchoan R, Pluda IM, Thomas RV, Marczyk KS, Broder S, Johns DG: Pharmacokinetics of 2′,3′-dideoxyadenosine and 2′,3′-dideoxyinosine in patients with severe human immunodeficiency virus infection. Clin Pharmacol Ther 1990; 47:647-654.
21. Knupp CA, Shyu WC, Dolin R, Valentine ET, McClaren C, Martin RR, et al: Pharmacokinetics of didanosine in patients with acquired immunodeficiency syndrome or acquired immunodeficiency syndrome-related complex. Clin Pharmacol Ther 1991; 49:523-535.
22. Collier AC, Coombs RW, Fischl MA, Skolnik PR, Northfelt D, Boulin P, et al: Combination therapy with zidovudine and didanosine compared with zidovudine alone in HIV-1 infection. Ann Intern Med 1993;119:786-793.
23. Morse GD, Shelton MJ, Ho M, Bartos L, DeRemer M, Ragni M: Pharmacokinetics of zidovudine and didanosine during combination therapy. Antiviral Res 1995;27:419-424.
24. Sahai J, Gallicano K, Garber G, Pakuts A, Cameron W: Pharmacokinetics of simultaneously administered zidovudine and didanosine in HIV-seropositive male patients. J AIDS Human Retrovir 1995;10:54-60.
25. Barry M, Howe JL, Ormesher S, Back DJ, Breckenbridge AM, Bergin C, et al: Pharmacokinetics of zidovudine and dideoxyinosine alone and in combination in patients with the acquired immunodeficiency syndrome. Br J Clin Pharmacol 1994;37:421-426.
26. Gibaldi M: Biopharmaceutics and Clinical Pharmacokinetics. Third Edition. New York: Lea & Febiger, 1984.
27. Furman PA, Fyfe JA, St Clair MH, Weinhold K, Rideout JL, Freeman GA, et al: Phosphorylation of 3′-azido-3′-deoxythymidine and selective interaction of the 5′-triphosphate with human immunodeficiency virus reverse transcriptase. Proc Natl Acad Sci U S A 1986;83:8333-8337.
28. Good SS, Koble CS, Crouch R, Johnson RL, Rideout JL, de Miranda P: Isolation and characterization of an ether glucuronide of zidovudine, a major metabolite in monkeys and humans. Drug Metab Dispos 1990;18:321-326.
29. Zhou XJ, Sommadossi JP: Comparative pharmacokinetics of zidovudine and its toxic catabolite 3′-amino-3′-deoxythymidine in HIV-infocted patients. Aids Res Human Retroviruses 1996; 12:229-233.
30. Zhou-Pan XR, Cretton-Scott E, Zhou XJ, Yang MX, Lasker JM, Sommadossi JP: Human liver cytochromes P450 and b5 act as reductases in the metabolism of 3′-azido-3′-deoxythymidine to 3′-amino-3′-deoxythymidine. Mol Pharmacol 1996, in press.
31. Placidi L, Cretton EM, Placidi M, Sommadossi JP: Reduction of 3′-azido-3′-deoxythymidine to 3′-amino-3′-deoxythymidine in human liver microsomes and its relationship to cytochrome P450. Clin Pharmacol Ther 1993;54:168-176.
32. Stoltz ML, El-hawari M, Litle L, Smith AC, Tomas-Zewski JE, Grieshaher CK: Pharmacokinetics and bioavailability of 2′,3′-dideoxynucleoside anti-AIDS agents in beagle dogs. Proc Am Assoc Cancer Res 1989;30:535.
33. Ahluwalia G, Cooney DA, Mitsuya H, Fridland A, Flora KP, Hao Z, et al: Initial studies on the cellular pharmacology of 2′,3′-dideoxyinosine, an inhibitor of HIV infectivity. Biochem Pharmacol 1987;36:3797-3800.
34. McLaren C, Datema R, Knupp CA, Buroker RA: Review: didanosine. Antiviral Chem Chemother 1991;2:321-328.
35. Stoeckler JD, Cambor C, Parks RE: Human erythrocytic purine nucleoside phosphorylase: reaction with sugar-modified nucleoside substrates. Biochemistry 1980;19:102-107.
36. Yarchoan R, Mitsuya H, Thomas RV, Pluda JM, Hartman NR, Perno CF, et al: In vivo activity against HIV and favorable toxicity profile of 2′,3′-dideoxyinosine. Science 1989;245:412-415.
37. Mattes H, Benezra C: Synthesis of a model hapten with cyclohexanediol and a-methylene-g-butyrolactone groups, a synthetic analogue of poison ivy and tulipalin allergens connected with a carbon chain. J Org Chem 1988;53:2732-2737.
38. Hao Z, Ford H, Ahluwalia G, Yeh H, Barchi J, Jones DJ, Cooney DA: 2,3-Dideoxyribose-1-phosphate, a major metabolite of the anti-HIV dideoxypurine ddIno. Proc Am Assoc Cancer Res 1992;33:398.
39. Dudley MN: Clinical pharmacokinetics of nucleoside antiretroviral agents. J Infect Dis 1995;171:99-112.