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

This study has been completed.
Sponsor:
Information provided by:
Netherlands Organisation for Scientific Research
ClinicalTrials.gov Identifier:
NCT00553137
First received: November 2, 2007
Last updated: May 2, 2008
Last verified: May 2008

November 2, 2007
May 2, 2008
November 2006
December 2007   (final data collection date for primary outcome measure)
clinical and mycological cure [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]
clinical and mycological cure [ Time Frame: two weeks ]
Complete list of historical versions of study NCT00553137 on ClinicalTrials.gov Archive Site
recurrence post treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
recurrence post treatment [ Time Frame: 4 weeks ]
Not Provided
Not Provided
 
Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania
Oral Candidiasis in HIV Infected Individuals in Tanzania

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Oropharyngeal Candidiasis
  • Drug: fluconazole
    750 mg (5 tablets of 150 mg tablets)taken once
  • Drug: fluconazole
    150 mg fluconazole tablets once daily for 14 days
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00553137
fluc trial tz
Yes
Not Provided
Netherlands Organisation for Scientific Research
Not Provided
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
Netherlands Organisation for Scientific Research
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP