Clinical trial NCT00553137: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oropharyngeal Candidiasis
Keywords: oropharyngeal candidiasis
Lead sponsor: Netherlands Organisation for Scientific Research
Sponsor class: OTHER_GOV
First posted: 2007-11-04
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: clinical and mycological cure
timeFrame: two weeks
Secondary outcomes:
measure: recurrence post treatment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: ART clinic Muhimbili National Hospital/Muhimbili University College of Health Sciences
Study officials:
affiliation: Department of Oral Surgery and Oral Pathology, Muhimbili University College of Health Sciences
name: Omar JM Hamza, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of microbiology, Muhimbili University College of Health Sciences
name: Mecky IN Matee, PhD
role: STUDY_CHAIR
affiliation: Department of Internal Medicine, Muhimbili University College of Health Sciences
name: Ferdinand Mugusi, MD,MMED
role: STUDY_CHAIR
affiliation: Centre for Infectious Disease, Internal Medicine Department, Radboud University Nijmegen, the Netherlands
name: Andre JA Van der Ven, PhD
role: STUDY_DIRECTOR
affiliation: Department of Medical Microbiology, Radboud University Nijmegen, the Netherlands
name: Paul E Verweij, PhD
role: STUDY_CHAIR
References:
citation: 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.