Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania (SDVS2WK)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00553137 |
Recruitment Status :
Completed
First Posted : November 4, 2007
Last Update Posted : May 7, 2008
|
Tracking Information | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | November 2, 2007 | |||||||||||||||
First Posted Date ICMJE | November 4, 2007 | |||||||||||||||
Last Update Posted Date | May 7, 2008 | |||||||||||||||
Study Start Date ICMJE | November 2006 | |||||||||||||||
Actual Primary Completion Date | December 2007 (Final data collection date for primary outcome measure) | |||||||||||||||
Current Primary Outcome Measures ICMJE |
clinical and mycological cure [ Time Frame: two weeks ] | |||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | |||||||||||||||
Change History | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
recurrence post treatment [ Time Frame: 4 weeks ] | |||||||||||||||
Original Secondary Outcome Measures ICMJE | Same as current | |||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Descriptive Information | ||||||||||||||||
Brief Title ICMJE | Single Dose Versus Two Weeks Course of Fluconazole in the Treatment of Oropharyngeal Candidiasis in HIV Infected Individuals in Tanzania | |||||||||||||||
Official Title ICMJE | Oral Candidiasis in HIV Infected Individuals in Tanzania | |||||||||||||||
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. |
|||||||||||||||
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 |
|||||||||||||||
Study Type ICMJE | Interventional | |||||||||||||||
Study Phase ICMJE | Phase 4 | |||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
|||||||||||||||
Condition ICMJE | Oropharyngeal Candidiasis | |||||||||||||||
Intervention ICMJE |
|
|||||||||||||||
Study Arms ICMJE |
|
|||||||||||||||
Publications * | Hamza OJ, Matee MI, Brüggemann 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. | |||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||||||||
Recruitment Information | ||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||
Actual Enrollment ICMJE |
220 | |||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | |||||||||||||||
Actual Study Completion Date ICMJE | December 2007 | |||||||||||||||
Actual Primary Completion Date | December 2007 (Final data collection date for primary outcome measure) | |||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||||||||||||||
Sex/Gender ICMJE |
|
|||||||||||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||
Listed Location Countries ICMJE | Tanzania | |||||||||||||||
Removed Location Countries | ||||||||||||||||
Administrative Information | ||||||||||||||||
NCT Number ICMJE | NCT00553137 | |||||||||||||||
Other Study ID Numbers ICMJE | fluc trial tz | |||||||||||||||
Has Data Monitoring Committee | Yes | |||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||
Responsible Party | Not Provided | |||||||||||||||
Study Sponsor ICMJE | Netherlands Organisation for Scientific Research | |||||||||||||||
Collaborators ICMJE | Not Provided | |||||||||||||||
Investigators ICMJE |
|
|||||||||||||||
PRS Account | Netherlands Organisation for Scientific Research | |||||||||||||||
Verification Date | May 2008 | |||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |