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

NCT00553137 | Completed Phase 4 DMC

• 1 other identifier: fluc trial tz
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Oropharyngeal Candidiasis

Keywords

oropharyngeal candidiasis

Outcome Measures

Primary Outcomes (1)

• clinical and mycological cure

  two weeks

Secondary Outcomes (1)

• recurrence post treatment

  4 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

single dose fluconazole (750 mg) and placebos 150 mg tablets once daily for 14 days

Drug: fluconazole

2

ACTIVE COMPARATOR

150 mg fluconazole once daily for 14 days and placebos (5 placebos tablets) 750 mg once

Drug: fluconazole

Interventions

fluconazole DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infection (as determined by positive ELISA and confirmed by Western blot)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Netherlands Organisation for Scientific Research: lead

Study Sites (1)

ART clinic Muhimbili National Hospital/Muhimbili University College of Health Sciences

Dar es Salaam, Dar es Salaam Region, Box 65001, Tanzania

Location

Related Publications (1)

• Hamza OJ, Matee MI, Bruggemann RJ, Moshi MJ, Simon EN, Mugusi F, Mikx FH, van der Lee HA, Verweij PE, van der Ven AJ. Single-dose fluconazole versus standard 2-week therapy for oropharyngeal candidiasis in HIV-infected patients: a randomized, double-blind, double-dummy trial. Clin Infect Dis. 2008 Nov 15;47(10):1270-6. doi: 10.1086/592578.

  PMID: 18840077 DERIVED

MeSH Terms

Interventions

Fluconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Omar JM Hamza, DDS

  Department of Oral Surgery and Oral Pathology, Muhimbili University College of Health Sciences

  PRINCIPAL INVESTIGATOR

• Mecky IN Matee, PhD

  Department of microbiology, Muhimbili University College of Health Sciences

  STUDY CHAIR

• Ferdinand Mugusi, MD,MMED

  Department of Internal Medicine, Muhimbili University College of Health Sciences

  STUDY CHAIR

• Andre JA Van der Ven, PhD

  Centre for Infectious Disease, Internal Medicine Department, Radboud University Nijmegen, the Netherlands

  STUDY DIRECTOR

• Paul E Verweij, PhD

  Department of Medical Microbiology, Radboud University Nijmegen, the Netherlands

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 5, 2007
• Study Start: November 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 7, 2008

Record last verified: 2008-05

Locations

TA (1)