Skip to main content
. 2010 Nov 10;2010(11):CD003940. doi: 10.1002/14651858.CD003940.pub3

De Wit 1997.

Methods Multicenter, multi‐country study ‐ 4 hospitals: Brussels; London; Manchester; Paris
Dates of enrolment and/or randomisation not reported.
Loss to follow‐up: 
 D1 ‐ 3/13 (23%) 
 D2 ‐ 0/14 (0%)
Analysis: no ITT
Participants Eligibility criteria: HIV positive, age 18‐62 years, patients who had oro‐pharyngeal with or without esophageal candidiasis
Exclusion criteria: History of clinical failure of fluconazole, abnormal ECG, concomitant medication with agents known to induce cytochrome P450 or to interact with azoles, history of intolerance to azoles, acute or chronic liver disease.
Diagnosis confirmed by colony forming units on culture
27 patients enrolled 
 D1= 13 
 D2= 14
Interventions D1 ‐ D0870 100mg initial dose followed by 25 mg/day for 4 days 
 D2 ‐ D0870 10mg once daily for 5 days
Outcomes Clinical response was recorded as cleared, improved, failure or not evaluable.
Relapse: Patients were assessed 7 and 14 days after end of treatment for evaluation of relapses.
Adverse events: 1 patients experienced dizziness (D1) and another had diarrhoea (D2).
Notes Ethics: IRB of each centre approved protocol and 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? Unclear risk "..sealed envelopes detailing the allocation randomised treatment"
Blinding? 
 All outcomes Unclear risk Reported double blinding. Specified that participants were blinded. Unclear who else was blinded.
Incomplete outcome data addressed? 
 All outcomes Low risk Reasons for lost to follow‐up given