Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania (SDVS2WK)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Oral Candidiasis in HIV Infected Individuals in Tanzania|
- clinical and mycological cure [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]
- recurrence post treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2006|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Active Comparator: 1
single dose fluconazole (750 mg) and placebos 150 mg tablets once daily for 14 days
750 mg (5 tablets of 150 mg tablets)taken once
Active Comparator: 2
150 mg fluconazole once daily for 14 days and placebos (5 placebos tablets) 750 mg once
150 mg fluconazole tablets once daily for 14 days
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553137
|ART clinic Muhimbili National Hospital/Muhimbili University College of Health Sciences|
|Dar es Salaam, Tanzania, Box 65001|
|Principal Investigator:||Omar JM Hamza, DDS||Department of Oral Surgery and Oral Pathology, Muhimbili University College of Health Sciences|
|Study Chair:||Mecky IN Matee, PhD||Department of microbiology, Muhimbili University College of Health Sciences|
|Study Chair:||Ferdinand Mugusi, MD,MMED||Department of Internal Medicine, Muhimbili University College of Health Sciences|
|Study Director:||Andre JA Van der Ven, PhD||Centre for Infectious Disease, Internal Medicine Department, Radboud University Nijmegen, the Netherlands|
|Study Chair:||Paul E Verweij, PhD||Department of Medical Microbiology, Radboud University Nijmegen, the Netherlands|