Oral Candidiasis in HIV Infected Individuals in Tanzania
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- clinical and mycological cure
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
1
single dose fluconazole (750 mg) and placebos 150 mg tablets once daily for 14 days
干预措施: fluconazole (Drug)
2
150 mg fluconazole once daily for 14 days and placebos (5 placebos tablets) 750 mg once
干预措施: fluconazole (Drug)
结局指标
主要结局
clinical and mycological cure
时间窗: two weeks
次要结局
- recurrence post treatment(4 weeks)