BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent
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. We expect that patients with HIV+SGD+ will have elevated oral BK polyomavirus viral loads and will benefit from Ciprofloxacin.
Salivary Gland Disease
Benign Lymphoepithelial Lesion
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||BK Virus in Salivary Gland Disease|
- (BK) Virus replication and shedding [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]It has been determined that patients with (HIVSGD) shed high levels of (BK) Virus and have evidence of replicating (BK) Virus in their salivary gland tissues. Body fluids and salivary gland tissue will be assessed for evidence of (BK) Virus replication. It will be determine whether Cipro administration decreases (BK) Virus replication in patients with (HIVSGD).
- Salivary function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]It will be determine whether salivary gland function is improved or restored with the administration of Cipro.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Ciprofloxacin
over encapsulated, 500mg bid, 28 days
20 (SGDHIV) Participants will be randomized to either Ciprofloxacin or a Placebo arm. Ciprofloxacin 500mg will be over encapsulated and taken 2x daily for 28days, Placebo will also be over encapsulated and taken 2x daily for 28days. This study is double blinded. Each study participant will be consented and be required to complete study questionnaires.
Other Name: Cipro
Placebo Comparator: Placebo
Over encapsulated to match active comparator, bid, 28 days
Please refer to this study by its ClinicalTrials.gov identifier: NCT02068846
|Contact: Jo-Ann A Blake, RDH, MPH||919 firstname.lastname@example.org|
|Contact: Jennifer Webster-Cyriaque, DDS, PhD|
|United States, North Carolina|
|The University of North Carolina School of Dentistry||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator: Jennifer Webster-Cyriaque, DDS, PhD|
|Principal Investigator:||Jennifer Webster-Cyriaque, DDS, PhD||The University of North Carolina School of Dentistry|