Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2007

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

Intervention(s) in this Clinical Trial

• Drug: fluconazole
  • 750 mg (5 tablets of 150 mg tablets)taken once
• Drug: fluconazole
  • 150 mg fluconazole tablets once daily for 14 days

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • single dose fluconazole (750 mg) and placebos 150 mg tablets once daily for 14 days
• Active Comparator: 2
  • 150 mg fluconazole once daily for 14 days and placebos (5 placebos tablets) 750 mg once

Primary Measures

• clinical and mycological cure
  • Time Frame: two weeks
    Safety Issue?: Yes

Secondary Measures

• recurrence post treatment
  • Time Frame: 4 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Netherlands Organisation for Scientific Research

Overall Clinical Trial Officials and Contacts

Omar JM Hamza, DDS Principal Investigator Department of Oral Surgery and Oral Pathology, Muhimbili University College of Health Sciences  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00553137

Study ID Number: fluc trial tz

ClinicalTrials.gov Identifier: NCT00553137

Health Authority: Tanzania: Ministry of Health