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

Phase 3

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo treatment twice daily for 28 days
Ciprofloxacin	Ciprofloxacin	Active treatment twice daily for 28 days

Primary Outcome Measures

Name	Time	Method
BK Viral Status in Saliva at Week 4	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	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting Dry Mouth "Yes/No" at Week 4	Week 4	Participants were asked "Have you noticed any change in your salivary glands or in the dryness of your mouth"
Number of Participants Reporting Dry Mouth "Yes/No" at Week 12	Week 12	Participants were asked "Have you noticed any change in your salivary glands or in the dryness of your mouth"
Unstimulated Salivary Flow Rate at Week 4	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.
Unstimulated Salivary Flow Rate at Week 12	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.