Graybill 1998a.

Methods	Location of study: USA Multicentre: 12 centres Only patients randomised whose efficacy outcome was cured or improved was evaluable for follow up Loss to follow‐up: discrepancy between text (157) and tables (146) as to number who completed treatment According to table ‐ Ictraconazole 7d ‐ 10/64 (17%) Ictraconazole 14d ‐ 10/64 (17%) Fluconazole ‐ 13/62 (21%) Analysis: no ITT
Participants	Eligibility criteria: HIV positive adult patients randomised (> 13 years), clinical picture of oropharyngeal candidiasis with findings on direct microscope examination (KOH smear) consistent with Candida spp and subsequently confirmed by positive mycological culture. Exclusion criteria: presence of perioral lesions only, esophageal involvement, history of significant hepatic abnormalities / clinical evidence hepatic disease within two months of entering study, life expectancy < 1 month or clinical condition such that study completion could not be assured, hypersensitivity to imidazole or azole compounds, pregnant or breastfeeding, therapy with other antifungal agents, H2 receptor blockers, antacids, rifampicin, rifabutin, phenobarbital, phenytoin, carbamazepine, terfenadine, astemizole. Diagnosis confirmed using KOH and culture 190 enrolled and randomised: 64 Itraconazole 7 days 64 Itraconazole 14 days 62 Fluconazole 14 days
Interventions	Compared 2 regimens of itraconazole oral solutions 200mg/day for 7 days 200mg/kg for 14 days with active control ‐ fluconazole tablets 200mg on day 1, 100mg daily for the remaining 13 days time period of interventions: 14 days
Outcomes	clinical response: cured (clearance of all signs and symptoms) / clinical improvement ( minimal signs and symptoms with no residual visible candida lesions) / clinical deterioration (worsening or increasing signs and symptoms) secondary outcomes: changes in symptoms from baseline (soreness/ burning, erythema) ; extent of oral lesions; quantification of CFU's; mycological cure : yeast quantification of </= 20 cfu/ml; Culture Adverse events: 25% each treatment arm GIT adverse events. Nausea, diarrhoea, abdominal pain most common. Respiratory side effects 21% fluconazole, 12.5% itraconazole.
Notes	Ethics: IRB of each centre approved study, written informed consent obtained
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Method of allocation sequence generation not specified
Allocation concealment?	High risk	"..open label.."
Blinding? All outcomes	Unclear risk	Third party blinded.