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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | single dose fluconazole (750 mg) and placebos 150 mg tablets once daily for 14 days |
|
| 2 | Active Comparator | 150 mg fluconazole once daily for 14 days and placebos (5 placebos tablets) 750 mg once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluconazole | Drug | 750 mg (5 tablets of 150 mg tablets)taken once |
| |
| Measure | Description | Time Frame |
|---|---|---|
| clinical and mycological cure | two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| recurrence post treatment | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omar JM Hamza, DDS | Department of Oral Surgery and Oral Pathology, Muhimbili University College of Health Sciences | Principal Investigator |
| 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 Chair |
| Andre JA Van der Ven, PhD | Centre for Infectious Disease, Internal Medicine Department, Radboud University Nijmegen, the Netherlands | Study Director |
| Paul E Verweij, PhD | Department of Medical Microbiology, Radboud University Nijmegen, the Netherlands | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ART clinic Muhimbili National Hospital/Muhimbili University College of Health Sciences | Dar es Salaam | Dar es Salaam Region | Box 65001 | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18840077 | Derived | Hamza OJ, Matee MI, Bruggemann RJ, Moshi MJ, Simon EN, Mugusi F, Mikx FH, van der Lee HA, Verweij PE, van der Ven AJ. Single-dose fluconazole versus standard 2-week therapy for oropharyngeal candidiasis in HIV-infected patients: a randomized, double-blind, double-dummy trial. Clin Infect Dis. 2008 Nov 15;47(10):1270-6. doi: 10.1086/592578. |
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| fluconazole |
| Drug |
150 mg fluconazole tablets once daily for 14 days |
|
| ID | Term |
|---|---|
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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