Revankar 1998.

Methods	Multicentre prevention trial. Patients followed up at Univ Texas Health Science Center in San Antonio and the Sout Texas Veterans Health Care System, Audie Murphy Division, San Antonio Texa, USA. Study period was 11 months. Loss to follow‐up: unclear Analysis: no ITT
Participants	Inclusion criteria: HIV positive with evidence of active oropharyngeal candidiasis by KOH and culture; CD4 cell count< 350x106/l; currently not taking any azole compound Exclusion criteria: known hypersensitivity to azole compounds; unable to take oral medications; pregnant; serum ALT /AST ratio > 10 x normal; serum ALP > 5x normal or bilirubin > 3 x normal. Diagnosis confirmed: yes ‐ KOH preparation and culture 62 patients enrolled 42 ‐ intermittent fluconazole therapy 20 ‐ continuous fluconazole therapy
Interventions	All patients treated with 200mg fluconazole on day 1 followed by 100mg/day for 4 days or until complete clinical response (resolution of symptoms and signs). Fluconazole ‐ intermittent : treated with fluconazole only during relapses of Candidiasis Fluconazole ‐ continuous : 200mg/day
Outcomes	Primary outcomes ‐ clinical development of lesions Microbiological counts Clinical response (defined as resolution of symptoms and clearance of lesions) Secondary outcomes ‐ development of yeast isolates with MIC > 16 ug/ml clinical failure to respond to 800mg/day of fluconazole
Notes	Ethics: approval obtained; informed consent taken Author contacted, no response to date 24/08/2004 Author contacted via email: 08/11/2004 (age groups)
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	2:1 using permuted blocks of 6
Allocation concealment?	High risk	Open label
Blinding? All outcomes	High risk	Open label study
Incomplete outcome data addressed? All outcomes	Low risk	No ITT. Those lost to follow‐up prior to 3 months of follow‐up not included in final analysis Reasons given why lost to follow‐up