Pagani 2002.

Methods	Recruited trial subjects from the Swiss HIV Cohort Study Patients were stratified according to CD4 count ( <=50 vs >50) and number of previous oropharyngeal episodes (<2 vs >=2) before randomisation Loss to follow‐up: Fluconazole ‐ 4/71 (6%) Placebo ‐ 1/72 (1%) Analysis: no ITT
Participants	Inclusion criteria: at least 16 years of age; HIV positive; documented oropharyngeal candidiasis who responded to a 7 day course of treatment with oral fluconazole 200mg daily. Exclusion criteria: < 16 years old; known hypersensitivity to azole compounds; documented Candida isolate resistant to fluconazole from baseline swab culture; ongoing systemic or topical secondary prevention for oropharyngeal candidiasis; ongoing fluconazole therapy for another reason; previous systemic antifungal drug within 15 days of planned study entry; creatinine > 150 micromol/L; ALT or ALP more than 5 times upper normal value. 143 patients enrolled 71 ‐ fluconazole therapy 72 ‐ placebo
Interventions	Fluconazole 150mg weekly Placebo weekly Duration: planned follow‐up per patient = 18 months Duration: 7 ‐ 14 days
Outcomes	Primary outcome was the third relapse of oropharyngeal candidiasis, the occurrence of an adverse event requiring drug discontinuation, and the development of microbiological resistance to fluconazole in association with clinical resistance. Oropharyngeal candidiasis was considered to be clinically documented when examination showed raised confluent white patches on a hyperaemic base or erythema alone. In the latter case it was required that microscopic confirmation be done. Adverse events: no participant dropped out because of a fluconazole related adverse event.
Notes	Ethics: ethics approval obtained from Ethics committee of Centre Hospitalier Universitaire Vaudois; informed consent obtained
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Method of sequence generation not described.
Allocation concealment?	Unclear risk	Not reported
Blinding? All outcomes	Unclear risk	Says double‐blind, but does not report who was blinded.
Incomplete outcome data addressed? All outcomes	Unclear risk	No ITT analysis