Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania (SDVS2WK)

This study has been completed.
Sponsor:
Information provided by:
Netherlands Organisation for Scientific Research
ClinicalTrials.gov Identifier:
NCT00553137
First received: November 2, 2007
Last updated: May 2, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Oropharyngeal Candidiasis
Drug: fluconazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Candidiasis in HIV Infected Individuals in Tanzania

Resource links provided by NLM:


Further study details as provided by Netherlands Organisation for Scientific Research:

Primary Outcome Measures:
  • clinical and mycological cure [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • recurrence post treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 220
Study Start Date: November 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
single dose fluconazole (750 mg) and placebos 150 mg tablets once daily for 14 days
Drug: fluconazole
750 mg (5 tablets of 150 mg tablets)taken once
Active Comparator: 2
150 mg fluconazole once daily for 14 days and placebos (5 placebos tablets) 750 mg once
Drug: fluconazole
150 mg fluconazole tablets once daily for 14 days

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553137

Locations
Tanzania
ART clinic Muhimbili National Hospital/Muhimbili University College of Health Sciences
Dar es Salaam, Tanzania, Box 65001
Sponsors and Collaborators
Netherlands Organisation for Scientific Research
Investigators
Principal Investigator: Omar JM Hamza, DDS Department of Oral Surgery and Oral Pathology, Muhimbili University College of Health Sciences
Study Chair: 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 Director: Andre JA Van der Ven, PhD Centre for Infectious Disease, Internal Medicine Department, Radboud University Nijmegen, the Netherlands
Study Chair: Paul E Verweij, PhD Department of Medical Microbiology, Radboud University Nijmegen, the Netherlands
  More Information

No publications provided by Netherlands Organisation for Scientific Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00553137     History of Changes
Other Study ID Numbers: fluc trial tz
Study First Received: November 2, 2007
Last Updated: May 2, 2008
Health Authority: Tanzania: Ministry of Health

Keywords provided by Netherlands Organisation for Scientific Research:
oropharyngeal candidiasis

Additional relevant MeSH terms:
Candidiasis
Mycoses
Fluconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014