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

Oropharyngeal Candidiasis Clinical Trial

— SDVS2WK  

Official title:

Oral Candidiasis in HIV Infected Individuals in Tanzania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553137
• Other study ID #: fluc trial tz
• Status: Completed
• Phase: Phase 4
• First received: November 2, 2007
• Last updated: May 2, 2008
• Start date: November 2006
• Est. completion date: December 2007

Study information

• Verified date: May 2008
• Source: Netherlands Organisation for Scientific Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Oropharyngeal Candidiasis

Intervention

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

Locations

Country	Name	City	State
Tanzania	ART clinic Muhimbili National Hospital/Muhimbili University College of Health Sciences	Dar es Salaam

Sponsors (1)

Lead Sponsor	Collaborator
Netherlands Organisation for Scientific Research

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical and mycological cure		two weeks	Yes
Secondary	recurrence post treatment		4 weeks	Yes