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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.

Sponsored by: Netherlands Organisation for Scientific Research
Information provided by: Netherlands Organisation for Scientific Research
ClinicalTrials.gov Identifier: NCT00553137
  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 IV

MedlinePlus related topics:   AIDS    Yeast Infections   

ChemIDplus related topics:   Fluconazole   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:   Oral Candidiasis in HIV Infected Individuals in Tanzania

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
1: Active Comparator
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
2: Active Comparator
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

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


Study ID Numbers:   fluc trial tz
First Received:   November 2, 2007
Last Updated:   May 2, 2008
ClinicalTrials.gov Identifier:   NCT00553137
Health Authority:   Tanzania: Ministry of Health

Keywords provided by Netherlands Organisation for Scientific Research:
oropharyngeal candidiasis  

Study placed in the following topic categories:
Fluconazole
Mycoses
Candidiasis, Oral
Candidiasis
Clotrimazole
HIV Infections
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole

Additional relevant MeSH terms:
Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




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