NCT00553137

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Netherlands Organisation for Scientific Research · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Oropharyngeal Candidiasis

Interventions

Type	Name	Description
DRUG	fluconazole	750 mg (5 tablets of 150 mg tablets)taken once
DRUG	fluconazole	150 mg fluconazole tablets once daily for 14 days

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-11-05
• Last updated: 2008-05-07

Locations

1 site across 1 country: Tanzania