Hamza 2008.

Methods	Participants recruited at HIV clinic of the Muhimbili National Hospital, Dar es Salaam, Tanzania from November 2006 through December 2007 Loss to follow‐up: 0% in both arms Analysis: ITT
Participants	Inclusion criteria: 18 years and older, documented HIV infection (determined by positive ELISA results and confirmed by Western‐blot analysis); clinical signs of OPC, visual lesions and microbiological confirmation. Exclusion criteria: Ongoing or previous topical or systemic antifungal therapy within 3 days before study enrolment. History of allergy to azole derivatives; abnormal liver function tests. Inability to tolerate oral dug administration. Pregnancy or breast‐feeding. Life expectancy of <4 weeks. Current participation in another clinical trial. Current treatment with drugs known to interact with fluconazole. documented systemic fungal infection. Symptoms suggestive of esophageal candidiasis. Fluconazole 14 days: 110 Fluconazole stat: 110 HAART: 41 in Stat group and 39 in 14 day group
Interventions	Fluconazole 14 days: 1 tablet of 150mg daily for two weeks plus 5 placebo tablets on first day of therapy. Fluconazole stat: Single dose of 750mg, i.e. 5 tablets of 150 mg on day one. One placebo tablet per day for two weeks. Treatment: 14 days Follow‐up: until 42 days from start of treatment
Outcomes	Primary outcomes:Clinical and mycological responses at end of treatment. Clinical cure = complete resolution of lesion, signs and symptoms of OPC. Improvement = reduction in number of lesions and symptoms, but persisting typical oropharyngeal lesions. Failure = no resolution of signs and symptoms. Mycological failure = any growth of Candida species on day 14 of culture. Secondary outcomes: relapse and safety Relapse = initial cure followed by reappearance of symptoms, signs and/or confirmation of positive yeast culture during a follow‐up period of four weeks at end of treatment. Adverse events reported in six patients in the 14‐day FCZ group, with all events being gastrointestinal. In the single‐dose group events were reported in 8 patients: 6 nausea, vomiting, abdominal pain, and/or diarrhea. One patient had a headache and 1 patient had heart palpitations.
Notes	Ethics: Ethics Committee of Muhimbili University of Health and Allied Sciences and Muhimbili National Hospital approved study protocol. Written informed consent from each participant.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Method not specified.
Allocation concealment?	Unclear risk	Methods not specified
Blinding? All outcomes	Low risk	Double‐blind, double‐dummy. Both patients and evaluator blinded.
Incomplete outcome data addressed? All outcomes	Low risk	All participants included in final analysis