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

NCT00553137 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2008-05-07

No results posted yet for this study

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.

Conditions

  • Oropharyngeal Candidiasis

Interventions

DRUG

fluconazole

750 mg (5 tablets of 150 mg tablets)taken once

DRUG

fluconazole

150 mg fluconazole tablets once daily for 14 days

Sponsors & Collaborators

  • Netherlands Organisation for Scientific Research

    lead OTHER_GOV

Principal Investigators

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

  • Mecky IN Matee, PhD · Department of microbiology, Muhimbili University College of Health Sciences

  • Ferdinand Mugusi, MD,MMED · Department of Internal Medicine, Muhimbili University College of Health Sciences

  • Andre JA Van der Ven, PhD · Centre for Infectious Disease, Internal Medicine Department, Radboud University Nijmegen, the Netherlands

  • Paul E Verweij, PhD · Department of Medical Microbiology, Radboud University Nijmegen, the Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00553137 on ClinicalTrials.gov