Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania (SDVS2WK)
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|ClinicalTrials.gov Identifier: NCT00553137|
Recruitment Status : Completed
First Posted : November 5, 2007
Last Update Posted : May 7, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Oropharyngeal Candidiasis||Drug: fluconazole||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Oral Candidiasis in HIV Infected Individuals in Tanzania|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
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
- clinical and mycological cure [ Time Frame: two weeks ]
- recurrence post treatment [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|