Marriott 1993.
Methods | Location of study: Australia Enrolment: Jan 1989 ‐ March 1990 Loss to follow‐up: Fluconazole: 13/44 = 29% Placebo: 14/40 = 35% Analysis: ITT |
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Participants | Inclusion criteria: male inpatients/outpatients, 18 years/older; with moderate to severe HIV infection who had been successfully treated with oropharyngeal candidiasis with fluconazole, 50mg daily for 14‐28 days. They were classified as clinically cured both at end of treatment and 7 days after the last dose of fluconazole Exclusion criteria: poor tolerance of fluconazole; taking drugs with low therapeutic ratio that are metabolized by the liver, such as barbiturates and coumarin anticoagulants; or if they were taking and other systemically administered antifungal drug; serum creatinine >= 220Umol/l; ALT, AST and ALP > 3 times upper limit of normal; total bilirubin >=350Umol/l and or prothrombin time > 5 seconds over control value 84 enrolled Fluconazole =44 Control group = 40 Diagnosis confirmed KOH and culture |
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Interventions | Weekly dose of 150mg fluconazole or placebo for 24 weeks (on the same day of each week) | |
Outcomes | Clinical recurrence of oral Candidiasis
Mycological outcome Adverse events: Fluconazole group ‐ 40 intercurrent illnesses, 9 adverse drug reactions, 3 deaths with Placebo group ‐ 5 intercurrent illnesses, 1 adverse drug reaction and 2 deaths. |
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Notes | Ethics: approval obtained; signed informed consent | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | Random allocation. Sequence computer generated. |
Allocation concealment? | High risk | Not reported |
Blinding? All outcomes | Unclear risk | Double blind. Participants blinded, does not mention who else. |
Incomplete outcome data addressed? All outcomes | Unclear risk | loss to follow‐up > 20%. Analysis ITT |