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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)

Primary Purpose

Oropharyngeal Candidiasis

Status

Completed

Phase

Phase 4

Locations

Tanzania

Study Type

Interventional

Intervention

fluconazole

About this trial

This is an interventional treatment trial for Oropharyngeal Candidiasis focused on measuring oropharyngeal candidiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

clinical and mycological cure

Secondary Outcome Measures

recurrence post treatment

Full Information

NCT ID

NCT00553137

First Posted

November 2, 2007

Last Updated

May 2, 2008

Sponsor

Netherlands Organisation for Scientific Research

1. Study Identification

Unique Protocol Identification Number

NCT00553137

Brief Title

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

Acronym

SDVS2WK

Official Title

Oral Candidiasis in HIV Infected Individuals in Tanzania

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Netherlands Organisation for Scientific Research

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oropharyngeal Candidiasis

Keywords

oropharyngeal candidiasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

220 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

fluconazole

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

fluconazole

Intervention Description

150 mg fluconazole tablets once daily for 14 days

Primary Outcome Measure Information:

Title

clinical and mycological cure

Time Frame

two weeks

Secondary Outcome Measure Information:

Title

recurrence post treatment

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: