A prospective randomized double blinded placebo controlled comparative trial will be performed at HIV clinic of the Muhimbili National Hospital/MUCHS where 220 HIV positive patients presenting with oropharyngeal candidiasis (OPC) on antiretroviral (ARVs) treatment or not will be included. The aim of this study is to compare the efficacy and safety of single dose fluconazole (750mg) and two weeks course of fluconazole (150mg once daily)in the treatment of OPC in HIV positive patients. It is hypothesised that the two regimens are equally effective in the treatment of OPC.
A structured standard questionnaire will be used to systematically collect essential data including demography, treatment history and concomitant infections and treatment. General and oral examination, collection of oral isolates, mycological, hematological and biochemical investigations will be done at baseline and at end of treatment day 13-14. All Patients will be followed up to 30 days after end of treatment for relapse
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
220
750 mg (5 tablets of 150 mg tablets)taken once
150 mg fluconazole tablets once daily for 14 days
ART clinic Muhimbili National Hospital/Muhimbili University College of Health Sciences
Dar es Salaam, Dar es Salaam Region, Tanzania
clinical and mycological cure
Time frame: two weeks
recurrence post treatment
Time frame: 4 weeks
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