NCT02068846

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

BK Virus in Salivary Gland Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV
• Salivary Gland Disease
• Benign Lymphoepithelial Lesion

Interventions

Type	Name	Description
DRUG	Ciprofloxacin	Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.
DRUG	Placebo	Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-02-21
• Last updated: 2019-07-11
• Results posted: 2019-07-11

Locations

1 site across 1 country: United States