BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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BK Virus in Salivary Gland Disease

Conditions
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HIV, Salivary Gland Disease, Benign Lymphoepithelial Lesion

Intervention / Treatment
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* Drug: Ciprofloxacin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV positive with Salivary Gland Disease Ability to read and understand English Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ciprofloxacin<br>Active treatment twice daily for 28 days | Drug: Ciprofloxacin<br>* Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.<br>* Other names: Cipro;|
| Placebo Comparator: Placebo<br>Placebo treatment twice daily for 28 days | Drug: Placebo<br>* Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BK Viral Status in Saliva at 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. | Week 4 | 
| BK Viral Status in Saliva at 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. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unstimulated Salivary Flow Rate at Week 4 | To determine whether salivary gland function is improved or restored with the administration of Cipro in participants with HIVSGD. After sitting at rest for 1 minute, participants collect drool using 50-mL conical tubes. The 5-minute unstimulated whole saliva flow rate recorded and collected. Salivary hypofunction is defined as unstimulated whole saliva flow rate ≤ 0.1 mL/min. Normal salivary function is defined as > 0.1 mL/min. | Week 4 | 
| Unstimulated Salivary Flow Rate at Week 12 | To determine whether salivary gland function is improved or restored with the administration of Cipro in participants with HIVSGD. After sitting at rest for 1 minute, participants collect drool using 50-mL conical tubes. The 5-minute unstimulated whole saliva flow rate recorded and collected. Salivary hypofunction is defined as unstimulated whole saliva flow rate ≤0.1 mL/min. Normal salivary function is defined as >0.1 mL/min. | Week 12 | 
| Number of Participants Reporting Dry Mouth Yes/No at Week 4 | Participants were asked Have you noticed any change in your salivary glands or in the dryness of your mouth | Week 4 | 
| Number of Participants Reporting Dry Mouth Yes/No at Week 12 | Participants were asked Have you noticed any change in your salivary glands or in the dryness of your mouth | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Salivary Gland Disease, Benign Lymphoepithelial Lesion, BK Polyomavirus