Document 2988
 DOCN  M94A2988
 TI    The Canadian randomized open-label trial of combination therapy for MAC
       bacteremia: mortality results. The Canadian MAC Study Group.
 DT    9412
 AU    Zarowny D; Cameron W; Fong I; Salit I; Lemieux C; Raboud J; Shafran S;
       Canadian HIV Trials Network, Vancouver.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):179 (abstract no. PB0144). Unique
       Identifier : AIDSLINE ICA10/94369587
 AB    OBJECTIVE: A randomized open label trial begun in November, 1992 is
       comparing the efficacy and safety of ciprofloxacin 750 mg BID,
       ethambutol 15 mg/kg QD, rifampin 600 mg QD and clofazimine 750 mg BID
       versus clarithromycin 1000 mg BID, rifabutin 600 mg QD and ethambutol 15
       mg/kg QD in HIV+patients with Mycobacterium avium complex (MAC)
       bacteremia. This abstract describes the mortality observed in the
       combined cohort. METHODS: All patients are followed intensively to 32
       weeks; survival is monitored beyond this period. The Cox proportional
       hazards models was used to assess the effect of baseline variables
       thought to be of prognostic importance. RESULTS: The analysis was based
       on all patients for whom baseline blood culture results had been
       received (N = 125). Although all patients were blood culture positive at
       local laboratories, some of these were not confirmed at the study
       central laboratory. The initial analysis compared the survival
       experience of patients who proved to be culture negative at baseline (N
       = 23) compared to those who were culture positive (N = 102). Patients
       who were blood culture negative tended to be at lower risk RR = .51, 95%
       CI = .68, 5.74, p = .21. The remaining analyses were restricted to the
       culture positive group. Forty-six deaths have occurred within the
       initial 32 week follow-up period. A Kaplan-Meier curve indicated a
       median survival time from randomization of approximately 6 months.
       Regression analysis was restricted to those patients who were culture
       positive at baseline. Only one factor that was significantly related to
       mortality; those not on antiretroviral therapy were at higher risk than
       those on antriretroviral therapy (RR = 2.26, 95% CI = 1.06, 4.87), p =
       .04. Karnofsky score, symptom score, and quantitative culture did not
       predict survival. CONCLUSION: The mortality observed in this study is
       not dissimilar to that observed in previous reports. The one significant
       predictor of mortality, absence of antiretroviral therapy, is likely
       markers of depressed immune status.
 DE    Antitubercular Agents/*THERAPEUTIC USE  AIDS-Related Opportunistic
       Infections/*DRUG THERAPY/MORTALITY  Bacteremia/*DRUG THERAPY/MORTALITY
       Ciprofloxacin/THERAPEUTIC USE  Clarithromycin/THERAPEUTIC USE
       Clofazimine/THERAPEUTIC USE  Cohort Studies  Comparative Study
       Dose-Response Relationship, Drug  Drug Administration Schedule  Drug
       Therapy, Combination  Ethambutol/THERAPEUTIC USE  Follow-Up Studies
       Human  Mycobacterium avium-intracellulare Infection/*DRUG THERAPY/
       MORTALITY  Proportional Hazards Models  Rifabutin/THERAPEUTIC USE
       Rifampin/THERAPEUTIC USE  Survival Rate  Treatment Outcome  CLINICAL
       TRIAL  MEETING ABSTRACT  RANDOMIZED CONTROLLED TRIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).