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

• ClinicalTrials.gov Identifier: NCT00553137
• Recruitment Status: Completed
• First Posted: November 4, 2007
• Last Update Posted: May 7, 2008
• Sponsor: Netherlands Organisation for Scientific Research
• Information provided by: Netherlands Organisation for Scientific Research

Tracking Information

• First Submitted Date: November 2, 2007
• First Posted Date: November 4, 2007
• Last Update Posted Date: May 7, 2008
• Study Start Date: November 2006
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 2, 2007): clinical and mycological cure [ Time Frame: two weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: November 2, 2007): recurrence post treatment [ Time Frame: 4 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Oropharyngeal Candidiasis

Intervention

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 2, 2007): 220
• Original Estimated Enrollment: 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

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, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Tanzania

Administrative Information

• NCT Number: NCT00553137
• Other Study ID Numbers: 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: Netherlands Organisation for Scientific Research
• Collaborators: Not Provided

Investigators

• 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