A randomized, placebo-controlled study of rifabutin added to a regimen of clarithromycin and ethambutol for treatment of disseminated infection with Mycobacterium avium complex

Clinical Infectious Diseases

Volumn 28, Issue 5, 1999, Pages 1080-1085

  Gordin, Fred M ^b   Sullam, Paul M ^c   Shafran, Stephen D ^c   Cohn, David L ^c   Wynne, Beverley ^a   Paxton, Linda ^c   Perry, Kim ^c   Horsburgh Jr , C R ^c  

^a Roxanne Laboratories Inc   (United States)

^b Infectious Diseases (151B)   (United States)

^c NONE

Author keywords

[No Author keywords available]

Indexed keywords

CLARITHROMYCIN; ETHAMBUTOL; PLACEBO; RIFABUTIN;

ABDOMINAL PAIN; ACQUIRED IMMUNE DEFICIENCY SYNDROME; ADULT; ANTIBIOTIC RESISTANCE; ARTICLE; BACTEREMIA; BLOOD CULTURE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; FEVER; HUMAN; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYCOBACTERIOSIS; MYCOBACTERIUM INTRACELLULARE AVIUM; NEUTROPENIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RASH; SURVIVAL TIME; SWEATING; SYMPTOM; UVEITIS;

EID: 0012000680     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/514748     Document Type: Article

References (38)

1. 1. Zakowski P, Fligiel S, Berlin GW, Johnson L Jr. Disseminated Mycobacterium avium-intracellulare infection in homosexual men dying of acquired immunodeficiency. JAMA 1982;248:2980-2.
2. 2. Macher AM, Kovacs JA, Gill V, et al. Bacteremia due to Mycobacterium avium-intracellulare in the acquired immunodeficiency syndrome. Ann Intern Med 1983;99:782-5.
3. 3. Nightingale SD, Byrd LT, Southern PM, Jockush JD, Cal SX, Wynne BA. Incidence of Mycobacterium avium-intracellulare complex bacteremia in human immunodeficiency virus-positive patients. J Infect Dis 1992; 165:1082-5.
4. 4. Jacobson MA, Hopewell PC, Yajko DM, et al. Natural history of disseminated Mycobacterium avium complex infection in AIDS. J Infect Dis 1991;164:994-8.
5. 5. Agins BD, Berman DS, Spicehandler D, El-Sadr W, Simberkoff MS, Rahal JJ. Effect of combined therapy with ansamycin, clofazimine, ethambutol, and isoniazid for Mycobacterium avium infection in patients with AIDS. J Infect Dis 1989;159:784-7.
6. 6. Hoy J, Mijch A, Sandland M, Grayson L, Lucas R, Dwyer B. Quadruple-drug therapy for Mycobacterium-avium intracellulare bacteremia in AIDS patients. J Infect Dis 1990;161:801-5.
7. 7. Chiu J, Nussbaum J, Bozzette S, et al. Treatment of disseminated Mycobacterium avium complex infection in AIDS with amikacin, ethambutol, rifampin, and ciprofloxacin. Ann Intern Med 1990;113:358-61.
8. 8. Kemper C, Meng TC, Nussbaum JT, et al. Treatment of Mycobacterium avium complex bacteremia in AIDS with a four-drug oral regimen. Ann Intern Med 1992;116:466-72.
9. 9. Horsburgh CR Jr, Havlik JA, Ellis DA, et al. Survival of patients with acquired immune deficiency syndrome and disseminated Mycobacterium avium complex infection with and without antimycobacterial chemotherapy. Am Rev Respir Dis 1991;144:557-9.
10. 10. Chin DP, Reingold AL, Stone EN, et al. The impact of Mycobacterium avium complex bacteremia and its treatment on survival of AIDS patients - a prospective study. J Infect Dis 1994;170:578-84.
11. 11. Kerlikowske KM, Katz MH, Chan AK, Perez-Stable EJ. Antimycobactcrial therapy for disseminated Mycobacterium avium complex infection in patients with acquired immunodeficiency syndrome. Arch Intern Med 1992;152:813-7.
12. 12. Horsburgh CR, Metchock B, Gordon SM, Havlik JA, McGowan JE, Thompson SE. Predictors of survival in patients with AIDS and disseminated Mycobacterium avium complex disease. J Infect Dis 1994;170: 573-7.
13. 13. Dautzenberg B, Truffot C, Legris S, et al. Activity of clarithromycin against Mycobacterium avium infection in patients with the acquired immune deficiency syndrome. Am Rev Respir Dis 1991;144:564-9.
14. 14. Chaisson RE, Benson CA, Dube MP, et al. Clarithromycin therapy for bacteremic Mycobacterium avium complex disease. Ann Intern Med 1994;121:905-11.
15. 15. Dautzenberg B, Saint Marc T, Meyohas MC, et al. Clarithromycin and other antimicrobial agents in the treatment of disseminated Mycobacterium avium infections in patients with acquired immunodeficiency syndrome. Arch Intern Med 1993;153:368-72.
16. 16. Masur H. Recommendations on prophylaxis and therapy for disseminated Mycobacterium avium complex disease in patients infected with the human immunodeficiency virus. N Engl J Med 1993;329:898-904.
17. 17. Kemper C, Havlir D, Haghighat D, et al. The individual microbiologic effect of three antimycobacterial agents, clofazimine, ethambutol, and rifampin, on Mycobacterium avium complex bacteremia in patients with AIDS. J Infect Dis 1994;170:157-64.
18. 18. Heifets LB, Iseman MD. Determination of in vitro susceptibility of mycobacteria to ansamycin. Am Rev Respir Dis 1985;132:710-1.
19. 19. Nightingale SD, Cameron DW, Gordin F, et al. Two controlled trials of rifabutin prophylaxis against Mycobacterium avium complex infection in AIDS. N Engl J Mod 1993;329:828-33.
20. 20. Dautzenberg B, Castellani P, Pellegrin JL, et al. Early bactericidal activity of rifabutin versus that of placebo in treatment of disseminated Mycobacterium avium complex bacteremia in AIDS patients. Antimicrob Agents Chemother 1996;40:1722-5.
21. 21. Sullam PM, Gordin FM, Wynne BA, the Rifabutin Treatment Group. Efficacy of rifabutin in the treatment of disseminated infection due to Mycobacterium avium complex. Clin Infect Dis 1994;19:84-6.
22. 22. Sanchez T, Vanderkolk J, Seay S, Heifets L. Quantification of mycobacteria in blood specimens from patients with AIDS. Tubercle Lung Dis 1994;75:386-90.
23. 23. Heifets LB, Lindholm-Levy PJ, Comstock RD. Clarithromycin minimal inhibitory and bactericidal concentrations. Am Rev Respir Dis 1992; 145:856-8.
24. 24. May T, Brel F, Beuscart C, et al. Comparison of combination therapy regimens for treatment of human immunodeficiency virus-infected patients with disseminated bacteremia due to Mycobacterium avium. Clin Infect Dis 1997;25:621-9.
25. 25. Dube MP, Sattler FR, Totriani FJ, et al. A randomized evaluation of ethambutol for prevention of relapse and drug resistance during treatment of Mycobacterium avium complex bacteremia with clarithromycin-based combination therapy. J Infect Dis 1997;176:1225-32.
26. 26. Ghebremichael S, Svenson SB, Kallenius G, Hoffner SE. Antimycobacterial synergism of clarithromycin and rifabutin. Scand J Infect Dis 1996; 28:387-90.
27. 3 [abstract no WcB421]. In: Program and abstracts of the 11th International Conference on AIDS. Vancouver; 11th International Conference on AIDS Society, 1996.
28. 28. Shafran SD, Singer J, Zarowny DP, et al. A comparison of two regimens for the treatment of Mycobacterium avium complex bacteremia in AIDS: rifabutin, ethambutol, and clarithromycin versus rifampin, ethambutol, clofazimine, and ciprofloxacin. N Engl J Med 1996;335:377-83.
29. 29. Griffith DE, Brown BA, Girard WM, Wallace RJ Jr. Adverse events associated with high-dose rifabutin in macrolide-containing regimens for the treatment of Mycobacterium avium complex lung disease. Clin Infect Dis 1995;21:594-8.
30. 30. Shafran SD, Singer J, Zarowny DP, et al. Determinants of rifabutin-associated uvcitis in patients treated with rifabutin, clarithromycin, and ethambutol for Mycobacterium avium complex bacteremia: a multivariate analysis. J Infect Dis 1998;177:252-5.
31. 31. Wallace RJ Jr, Brown BA, Griffith DE, Girard W, Tanaka K. Reduced serum levels of clarithromycin in patients treated with multidrug regimens including rifampin or rifabutin for Mycobacterium avium M. intracellular infection. J Infect Dis 1995;171:747-50.
32. 32. Hafner R, Bethel J, Power M, et al. Tolerance and pharmacokinetic interactions of rifabutin and clarithromycin in HIV-positive volunteers. Antimicrob Agents Chemother 1998;42:631-9.
33. 33. Young LS, Wiviott L, Wu M, Kolonoski P, Bolan R, Inderlied CB. Azithromycin for treatment of Mycobacterium avium-intracellulare complex infection in patients with AIDS. Lancet 1991;338: 1107-9.
34. 34. Ives DV, Davis RB, Currier JS. Impact of clarithromycin and azithromycin on patterns of treatment and survival among AIDS patients with disseminated Mycobacterium avium complex. AIDS 1995;9:261-6.
35. 35. Chaisson RE, Keiser P, Pierce M, et al. Clarithromycin and ethambutol with or without clofazimine for the treatment of bacteremic Mycobacterium avium complex disease in patients with HIV infection. AIDS 1997; 11:311-7.
36. 36. Kaplan JC, Masur H, Holmes KK, USPHS/IDSA Prevention of Opportunistic Infections Working Group. 1997 USPHS/IDSA guidelines for the prevention of opportunistic infections in persons infected with human immunodeficiency virus. MMWR Morb Mortal Wkly Rep 1997;46(RR-12):1-46.
37. 37. Vincent J, Foulds G, Apseloff G, Laboy-Goral L, Gerber N. Interaction of rifabutin with the macrolides azithromycin and clarithromycin [abstract no A29]. In: Program and abstracts of the 36th Interscience Conference on Antimicrobial Agents and Chemotherapy. Washington, DC: American Society for Microbiology, 1996.
38. 38. Havlir DV, Dube MP, Sattler FR, et al. Prophylaxis against disseminated Mycobacterium avium complex with weekly azithromycin, daily rifabutin, or both. N Engl J Med 1996;335:384-91.