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Sponsored by: |
Netherlands Organisation for Scientific Research |
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Information provided by: | Netherlands Organisation for Scientific Research |
ClinicalTrials.gov Identifier: | NCT00553137 |
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 |
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 |
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
|
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Tanzania | |
ART clinic Muhimbili National Hospital/Muhimbili University College of Health Sciences | |
Dar es Salaam, Tanzania, Box 65001 |
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 |
Study ID Numbers: | fluc trial tz |
Study First Received: | November 2, 2007 |
Last Updated: | May 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00553137 |
Health Authority: | Tanzania: Ministry of Health |
oropharyngeal candidiasis |
Fluconazole Mycoses Candidiasis, Oral Candidiasis Clotrimazole |
HIV Infections Miconazole Acquired Immunodeficiency Syndrome Tioconazole |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Pharmacologic Actions |