Oropharyngeal Candidiasis Clinical Trial
Official title:
Oral Candidiasis in HIV Infected Individuals in Tanzania
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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