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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Oral Candidiasis in HIV Infected Individuals in Tanzania

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 Summary:

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

Sponsor: Netherlands Organisation for Scientific Research

Current Primary Outcome: clinical and mycological cure [ Time Frame: two weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: recurrence post treatment [ Time Frame: 4 weeks ]

Original Secondary Outcome: Same as current

Information By: Netherlands Organisation for Scientific Research

Dates:
Date Received: November 2, 2007
Date Started: November 2006
Date Completion:
Last Updated: May 2, 2008
Last Verified: May 2008