Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania
Information source: Netherlands Organisation for Scientific Research
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Oropharyngeal Candidiasis
Intervention: fluconazole (Drug); fluconazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Netherlands Organisation for Scientific Research Official(s) and/or principal investigator(s):
Omar JM Hamza, DDS, Principal Investigator, Affiliation: Department of Oral Surgery and Oral Pathology, Muhimbili University College of Health Sciences
Mecky IN Matee, PhD, Study Chair, Affiliation: Department of microbiology, Muhimbili University College of Health Sciences
Ferdinand Mugusi, MD,MMED, Study Chair, Affiliation: Department of Internal Medicine, Muhimbili University College of Health Sciences
Andre JA Van der Ven, PhD, Study Director, Affiliation: Centre for Infectious Disease, Internal Medicine Department, Radboud University Nijmegen, the Netherlands
Paul E Verweij, PhD, Study Chair, Affiliation: Department of Medical Microbiology, Radboud University Nijmegen, the Netherlands
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.
Clinical Details
Official title: Oral Candidiasis in HIV Infected Individuals in Tanzania
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: clinical and mycological cure
Secondary outcome: recurrence post treatment
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
ART clinic Muhimbili National Hospital/Muhimbili University College of Health Sciences, Dar es Salaam Box 65001, Tanzania
Additional Information
Starting date: November 2006
Ending date: December 2007
Last updated: May 2, 2008
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