Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania
NCT ID: NCT00553137
Last Updated: 2008-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
220 participants
INTERVENTIONAL
2006-11-30
2007-12-31
Brief Summary
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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.
Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
single dose fluconazole (750 mg) and placebos 150 mg tablets once daily for 14 days
fluconazole
750 mg (5 tablets of 150 mg tablets)taken once
2
150 mg fluconazole once daily for 14 days and placebos (5 placebos tablets) 750 mg once
fluconazole
150 mg fluconazole tablets once daily for 14 days
Interventions
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fluconazole
750 mg (5 tablets of 150 mg tablets)taken once
fluconazole
150 mg fluconazole tablets once daily for 14 days
Eligibility Criteria
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Inclusion Criteria
* 18 years of age and above
* clinical picture of OPC, characterized by creamy, white, curd like patches, removable by scraping or by typical erythematous lesions (smooth red patches) on the oral mucosa, hard or soft palate and/or dorsal surface of the tongue; and microbiologically by visualization of yeast cells in Potassium hydroxide (10% KOH) preparations prepared from swab of visible lesions and confirmed positive Candida species culture
Exclusion Criteria
* History of allergy to azole derivatives
* Abnormal liver function tests defined as alanine aminotransferase (ALT), aspartate aminotransferases (AST), or total bilirubin greater than three times the upper limit of normal; or clinical evidence of significant hepatic or renal disease within two months prior to enrollment
* Inability to tolerate oral drug administration; pregnancy or breast feeding; life expectancy of less than four weeks
* Participation in another drug study at the time of enrollment, treatment with drug which interact with fluconazole, such as vitamin K antagonists, warfarin, sulfonylurea anti-diabetic agents, rifampicin, phenytoin, isoniazid, carbamazepine and cisapride
* Documented systemic fungal infections, symptoms suggestive of esophageal candidiasis such as retrosternal chest pain, dysphagia or odynophagia unless this condition has been ruled out by endoscopic examination.
* Patients with history of alcohol abuse, drug addiction and psychiatric disorder, inability to cooperate and poor motivation will be excluded from the study.
18 Years
ALL
No
Sponsors
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Netherlands Organisation for Scientific Research
OTHER_GOV
Principal Investigators
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Omar JM Hamza, DDS
Role: PRINCIPAL_INVESTIGATOR
Department of Oral Surgery and Oral Pathology, Muhimbili University College of Health Sciences
Mecky IN Matee, PhD
Role: STUDY_CHAIR
Department of microbiology, Muhimbili University College of Health Sciences
Ferdinand Mugusi, MD,MMED
Role: STUDY_CHAIR
Department of Internal Medicine, Muhimbili University College of Health Sciences
Andre JA Van der Ven, PhD
Role: STUDY_DIRECTOR
Centre for Infectious Disease, Internal Medicine Department, Radboud University Nijmegen, the Netherlands
Paul E Verweij, PhD
Role: STUDY_CHAIR
Department of Medical Microbiology, Radboud University Nijmegen, the Netherlands
Locations
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ART clinic Muhimbili National Hospital/Muhimbili University College of Health Sciences
Dar es Salaam, Dar es Salaam Region, Tanzania
Countries
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References
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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.
Other Identifiers
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fluc trial tz
Identifier Type: -
Identifier Source: org_study_id