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document
A placebo-controlled trial of maintenance therapy with fluconazole after treatment of cryptococcal meningitis in the acquired immunodeficiency syndrome . California Collaborative Treatment Group . BACKGROUND AND METHODS In patients with the acquired immunodeficiency syndrome ( AIDS ) , the rate of relapse after primary treatment for cryptococcal meningitis remains high . We conducted a controlled , double-blind trial to evaluate the efficacy of maintenance therapy with fluconazole . At entry into the study , all participants had sterile cultures of cerebrospinal fluid , blood , and urine after following a standardized course of therapy for culture-proved cryptococcal meningitis . The patients were randomly assigned to take either fluconazole or placebo as maintenance therapy . The dose of fluconazole was 100 mg daily in the first phase of study and 200 mg daily in the second phase . RESULTS Of 84 patients initially enrolled , 16 ( 19 percent ) were found to have silent , persistent infection on the basis of cultures that became positive after entry into the study ; 7 other patients were lost to follow-up shortly after entry . Of the remaining 61 patients , 10 of 27 assigned to placebo ( 37 percent ) and 1 of 34 assigned to fluconazole ( 3 percent ) had a recurrence of cryptococcal infection at any site ( difference in risk , 34 percent ; 95 percent confidence interval , 15 to 53 ) . Of the 11 recurrent infections , 7 were detected in urine obtained after prostatic massage . There were four recurrent meningeal infections in the patients taking placebo , but none in those taking fluconazole ( mean duration of follow-up , 164 days ) ( P = 0.03 ) . In multivariate analyses , the best predictors of recurrence-free survival were fluconazole treatment ( P = 0.02 ; relative hazard , 13.2 ) , a lower serum cryptococcal-antigen titer ( P = 0.05 ; relative hazard , 1.2 ) , and more prolonged primary therapy with flucytosine ( P = 0.09 ; relative hazard , 1.1 ) . Survival and toxicity were similar in the two maintenance-treatment groups . CONCLUSIONS In patients with AIDS , silent persistent infection is common after clinically successful treatment for cryptococcal meningitis . Maintenance therapy with fluconazole is highly effective in preventing recurrent cryptococcal infection .
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
fluconazole
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Intervention_Pharmacological
fluconazole
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Intervention_Control
placebo
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Intervention_Pharmacological
fluconazole
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Intervention_Control
placebo
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Intervention_Pharmacological
fluconazole
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Intervention_Control
placebo
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Intervention_Pharmacological
fluconazole
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Intervention_Pharmacological
fluconazole
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Intervention_Pharmacological
fluconazole
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Outcome_Physical
recurrence of cryptococcal infection at any site
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Outcome_Physical
recurrent meningeal infections
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Outcome_Mortality
recurrence-free survival
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Outcome_Mortality
Survival
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Outcome_Other
toxicity
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Participant_Condition
after treatment of cryptococcal meningitis in the acquired immunodeficiency syndrome .
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Participant_Condition
acquired immunodeficiency syndrome ( AIDS )
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Participant_Condition
cryptococcal meningitis
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Participant_Sample-size
84
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Participant_Sample-size
16
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Participant_Condition
infection
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Participant_Sample-size
7
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Participant_Sample-size
61
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Participant_Condition
AIDS