Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania (SDVS2WK)

Tracking Information
First Submitted Date ICMJE	November 2, 2007
First Posted Date ICMJE	November 5, 2007
Last Update Posted Date	May 7, 2008
Study Start Date ICMJE	November 2006
Actual Primary Completion Date	December 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 2, 2007)	clinical and mycological cure [ Time Frame: two weeks ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00553137 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 2, 2007)	recurrence post treatment [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania
Official Title ICMJE	Oral Candidiasis in HIV Infected Individuals in Tanzania
Brief Summary	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.
Detailed Description	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 ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Oropharyngeal Candidiasis
Intervention ICMJE	Drug: fluconazole 750 mg (5 tablets of 150 mg tablets)taken once; Drug: fluconazole 150 mg fluconazole tablets once daily for 14 days
Study Arms	Active Comparator: 1 single dose fluconazole (750 mg) and placebos 150 mg tablets once daily for 14 days Intervention: Drug: fluconazole; Active Comparator: 2 150 mg fluconazole once daily for 14 days and placebos (5 placebos tablets) 750 mg once Intervention: Drug: fluconazole
Publications *	Hamza OJ, Matee MI, Brüggemann 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: November 2, 2007)	220
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	December 2007
Actual Primary Completion Date	December 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: HIV infection (as determined by positive ELISA and confirmed by Western blot); 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: Patients who are currently receiving antifungal therapy or who had received such treatment within three days prior to enrollment in this study; 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Tanzania
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00553137
Other Study ID Numbers ICMJE	fluc trial tz
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Netherlands Organisation for Scientific Research
Collaborators ICMJE	Not Provided
Investigators ICMJE	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
PRS Account	Netherlands Organisation for Scientific Research
Verification Date	May 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP