BK Virus in Salivary Gland Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- BK Viral Status in Saliva at Week 4
研究概览
简要总结
The purpose of this study is to analyze BK viral infection in salivary gland diseases; specifically, to determine a definitive relationship between BK Virus and HIV associated salivary gland disease (HIVSGD). Participants are adults HIV+SGD+ who will be randomized 1:1 to receive BK Virus antiviral (ciprofloxacin) or placebo for 28 days. Salivary function/protein secretion will be correlated with BK polyomavirus titers. It is expected that patients with HIV+SGD+ will have elevated oral BK polyomavirus viral loads and will benefit from Ciprofloxacin.
详细描述
The study duration is 12 weeks with a baseline visit, a visit at 4 weeks and a visit at 12 weeks. At baseline participants are randomized to Ciprofloxacin or placebo and take the drug or placebo for 28 days. At subsequent visits BK polyomavirus presence and salivary gland function will be assessed.
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, Care Provider, Investigator)
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 positive with Salivary Gland Disease
- •Ability to read and understand English
排除标准
- •Allergy to the family of fluoroquinolones (including ciprofloxacin)
- •Currently taking tizanidine
- •Concurrently taking antiacids containing magnesium hydroxide or aluminum hydroxide
- •Current use of Theophylline
- •Previous tendon disorder such as Rheumatoid arthritis
- •History of seizures
- •Current use of phenytoin
- •Current use of glyburide
- •Current use of methotrexate
- •Severe renal impairment (known creatinine clearance < 30 or on dialysis)
研究组 & 干预措施
Ciprofloxacin
Active treatment twice daily for 28 days
干预措施: Ciprofloxacin (Drug)
Placebo
Placebo treatment twice daily for 28 days
干预措施: Placebo (Drug)
结局指标
主要结局
BK Viral Status in Saliva at Week 4
时间窗: Week 4
Oral fluids will be assessed for evidence of BK Virus replication to determine whether Cipro administration inhibits BK Virus replication in participants with HIVSGD. Oral fluids will be assessed by real-time PCR to determine BK Virus status as positive or negative.
BK Viral Status in Saliva at Week 12
时间窗: Week 12
Oral fluids will be assessed for evidence of BK Virus replication to determine whether Cipro administration inhibits BK Virus replication in participants with HIVSGD. Oral fluids will be assessed by real-time PCR to determine BK Virus status as positive or negative.
次要结局
- Number of Participants Reporting Dry Mouth "Yes/No" at Week 4(Week 4)
- Number of Participants Reporting Dry Mouth "Yes/No" at Week 12(Week 12)
- Unstimulated Salivary Flow Rate at Week 4(Week 4)
- Unstimulated Salivary Flow Rate at Week 12(Week 12)