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1994-10-25
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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).