A randomized trial of N-acetylcysteine for prevention of trimethoprim- sulfamethoxazole hypersensitivity reactions in pneumocystis carinii Pneumonia prophylaxis (CTN 057)

Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology

Volumn 19, Issue 5, 1998, Pages 498-505

  Walmsley, Sharon L ^a,c   Khorasheh, Shideh ^b   Singer, Joel ^b   Djurdjev, Ognjenka ^b  

^a UNIVERSITY OF TORONTO   (Canada)

^b Canadian HIV Trials Network   (Canada)

^c TORONTO GENERAL HOSPITAL   (Canada)

Author keywords

Glutathione; HIV infection; N' acetylcysteine; Pneumocystis carinii pneumonia; Trimethoprim sulfamethoxazole

Indexed keywords

ACETYLCYSTEINE; COTRIMOXAZOLE; GLUTATHIONE;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFECT; DRUG EFFICACY; DRUG HYPERSENSITIVITY; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFECTION RISK; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPPORTUNISTIC INFECTION; OUTCOMES RESEARCH; PNEUMOCYSTIS PNEUMONIA; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; SURVIVAL;

HUMAN IMMUNODEFICIENCY VIRUS; PNEUMOCYSTIS CARINII; RNA VIRUSES;

EID: 0032535616     PISSN: 10779450     EISSN: None     Source Type: Journal    
DOI: 10.1097/00042560-199812150-00009     Document Type: Article

References (40)

1. Hoover DR, Saah AJ, Bacellar H, et al. for the Multicenter AIDS Cohort Study. Clinical manifestations of AIDS in the era of pneumocystis prophylaxis: multicenter AIDS cohort study. N Engl J Med 1993;329:1992-6.
2. Masur H. Prevention and treatment of Pneumocystis pneumonia. N Engl J Med 1992;327:1853-60.
3. Chaison RE, Keruly J, Richman DD, Moore RD, and the Zidovudine Epidemiology Group. Pneumocystis prophylaxis and survival in patients with advanced human immunodeficiency virus infection treated with zidovudine. Arch Intern Med 1992;152:2009-13.
4. Bayard PJ, Berger TG, Jacobson MA. Drug hypersensitivity reactions and human immunodeficiency virus disease. J Acquir Immune Defic Syndr 1992;5:1237-57.
5. Koopmans PP, van der Ven AJAM, Vree TB, van der Meer JWM. Pathogenesis of hypersensitivity reactions to drugs in patients with HIV infection: allergic or toxic? AIDS 1995;9:217-22.
6. Gordin FM, Simon GL, Wofsy CB, Mills J. Adverse reactions to trimethoprim-sulfamethoxazole in patient with the acquired immunodeficiency syndrome. Ann Intern Med 1984;100:495-9.
7. Fischl MA, Dickinson GM, LaVoie L. Safety and efficacy of sulfamethoxazole and trimethoprim chemoprophylaxis for Pneumocystis carinii pneumonia in AIDS. JAMA 1988;259:1185-9.
8. Blum RN, Miller LA, Gaggini LC, Cohn DL. Comparative trial of dapsone versus trimethoprim/sulfamethoxazole for primary prophylaxis of Pneumocystis carinii pneumonia. J Acquir Immune Defic Syndr 1992;5:341-7.
9. Hardy WD, Feinberg J, Finkelstein DM, et al. A controlled trial of trimethoprim-sulfamethoxazole or aerosolized pentamidine for secondary prophylaxis of Pneumocystis carinii pneumonia in patients with the acquired immunodeficiency syndrome: AIDS clinical trial group protocol 021. N Engl J Med 1992;327:1842-8.
10. Schneider MME, Hoepelman AIM, Schattenkerk JKME, et al. A controlled trial of aerosolized pentamidine or trimethoprimsulfamethoxazole as primary prophylaxis against Pneumocystis carinii pneumonia in patients with human immunodeficiency virus infection. N Engl J Med 1992;327:1836-41.
11. Schneider MME, Nielsen TL, Nelsing S et al. Efficacy and toxicity of two doses of trimethoprim-sulfamethoxazole as primary prophylaxis against Pneumocystis carinii pneumonia in patients with human immunodeficiency virus. J Infect Dis 1995;71:1632-6.
12. Shafer RW, Seitzman PA, Tapper ML. Successful prophylaxis of Pneumocystis carinii pneumonia with trimethoprim-sulfamethoxazole in AIDS patients with previous allergic reactions. J Acquir Immune Defic Syndr 1989;2:389-93.
13. Walmsley SL, Levinton C, Brunton J et al. A multicentre randomized double-blind placebo-controlled trial of adjunctive corticosteroids in the treatment of Pneumocystis carinii pneumonia complicating the acquired immune deficiency syndrome. J Acquir Immune Defic Syndr 1995;8:348-57.
14. Shear NH, Spielberg SP, Grant DM, Tang BK, Kalow W. Differences in metabolism of sulfonamides predisposing to idiosyncratic toxicity. Ann Intern Med 1986;105:179-84.
15. van der Ven AJAM, Koopmans PP, Vree TB, van der Meer JWM. Adverse reactions to co-trimoxazole in HIV infection. Lancet 1991;338:431-3.
16. Larsson A, Orrenius S, Holmgren A, Mannervik B. Function of glutathione: biochemical, physiological, toxicological and clinical aspects. New York: Raven Press, 1983.
17. Rieder M, Uetrecht J, Shear N, Spielberg S. Synthesis and in vitro toxicity hydroxylamine metabolites of sulfonamides. J Pharmacol Exp Ther 1985;224:724-8.
18. Rieder MJ, Uetrecht J, Shear N, Cannon M, Miller M, Spielberg SP. Diagnosis of sulfonamide hypersensitivity reactions by in vitro "re-challenge" with hydroxylamine metabolites. Ann Intern Med 1989;110:286-89.
19. Buhl R, Holroyd KJ, Mastrangeli A, et al. Systemic glutathione deficiency in symptom-free HIV-seropositive individuals. Lancet 1989;2:1294-6.
20. Eck HP, Gmunder H, Hartmann M, Petzoldt D, Volker D, Droge W. Low concentrations of acid-soluble thiol (cysteine) in the blood plasma of HIV-infected patients. Biol Chem 1989;370:101-8.
21. Staal FJT, Ela SW, Roederer M, Anderson MT, Herzenberg LE, Herzenberg LA. Glutathione deficiency and human immunodeficiency virus infection. Lancet 1992;339:909-12.
22. Droge W. Cysteine and glutathione deficiency in AIDS patients: a rationale for the treatment with N′acetylcysteine. Pharmacol 1993; 46:61-5.
23. Staal FTJ, Roederer M, Israelski DM. Intracellular glutathione levels in T cell subsets decrease in HIV-infected individuals. AIDS Res Human Retroviruses 1992;8:305-11.
24. Walmsley SL, Harrison ML, Winn LM, Uetrecht JP, Wells PG. Increased oxidative stress and thiol depletion in plasma and peripheral blood lymphocytes from HIV+ and AIDS patients: toxicological and pathological implications. AIDS 1997;11:1689-99.
25. + lymphocytes associated with disturbed intracellular redox balance in human immunodeficiency virus type I infection. Blood 1995;86:258-67.
26. Holdiness MC. Clinical pharmacokinetics of N-acetylcysteine. Clin Pharmacokinet 1991;20:123-34.
27. Borgstrom L, Kagedal B, Paulson O. Pharmacokinetics of N′acetylcysteine in man. Eur J Res Dis 1980;61:45-51.
28. Witschi A, Reddy S, Stofer B, Lauterburg BH. The systemic availability of oral glutathione. Eur J Clin Pharmacol 1992;43:667-9.
29. + cells. FASEB J 1994;8:448-51.
30. de Quay B, Malinverni R, Lauterburg BH. Glutathione depletion in HIV-infected patients; role of cysteine deficiency and effect of oral N-acetylcysteine. AIDS 1992;6:815-19.
31. Witschi A, Junker E, Schranz C, Speck RF, Lauterburg BH. Supplementation of N-acetylcysteine fails to increase glutathione in lymphocytes and plasma of patients with AIDS. AIDS Res Human Retroviruses 1995;11:141-3.
32. Hosmer DV, Lemeshow S. Applied logistic regression. New York: John Wiley & Sons, 1989.
33. Lan KK, De Mets DL, Halperin M. More flexible sequential and non-sequential designs in long-term clinical trials. Commun Statist Theor Methods 1984;13:2339-53.
34. + lymphocyte count. J Infect Dis 1993;168:314-17.
35. Mitra AK, Thummel KE, Kalhorn TF, Kharasch ED, Unadkat JD, Slattery JT. Inhibition of sulfamethoxazole hydroxylamine formation by fluconazole in human liver microsomes and healthy volunteers. Clin Pharmacol Ther 1996;59:332-40.
36. Carr A, Gross AS, Hoskins JM, et al. Acetylation phenotype and cutaneous hypersensitivity to trimethoprim-sulfamethoxazole in HIV-infected patients. AIDS 1994;8:333-7.
37. Akerlans B, Tyrell E, Goran B, Lidman C. N′acetylcysteine treatment against adverse reactions to cotrimoxazole in HIV infection 1995 [Abstract 412]. Presented at the 5th European Conference on the Clinical Aspects and Treatment of HIV Infection, Copenhagen, Denmark, September 26-29, 1995.
38. Giorgi C, Micheli L, Fiaschi AI, et al. L-2-oxothiazolidine-4-carboxylic acid and glutathione in human immunodeficiency virus. Curr Therapeut Res 1992;52:461-7.
39. Kalayjian RC, Skowron G, Emgushov RT, et al. A phase I/II trial of intravenous L-2-oxothiazolidine-4-carboxylic acid (procysteine) in asymptomatic HIV-infected subjects. J Acquir Immune Defic Syndr 1994;7:369-74.
40. Prochaska HJ, Yeh Y, Baron P, Polsky B. Oltipraz, an inhibitor of human immunodeficiency virus type I replication. Proc Natl Acad Sci USA 1993;90:3953-7.