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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: BK Virus in Salivary Gland Disease

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. We expect that patients with HIV+SGD+ will have elevated oral BK polyomavirus viral loads and will benefit from Ciprofloxacin.

Detailed Summary:
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: (BK) Virus replication and shedding [ Time Frame: 12 weeks ]

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).


Original Primary Outcome: BKV replication and shedding [ Time Frame: 12 weeks ]

We have determined that patients with HIVSGD shed high levels of BKV and have evidence of replicating BKV in their salivary gland tissues. Body fluids and salivary gland tissue will be assessed for evidence of BKV replication. We will determine whether Cipro administration decreases BKV replication in patients with HIVSGD.


Current Secondary Outcome: Salivary function [ Time Frame: 12 weeks ]

It will be determine whether salivary gland function is improved or restored with the administration of Cipro.


Original Secondary Outcome: Salivary function [ Time Frame: 12 weeks ]

We will determine whether salivary gland function is improved or restored with the administration of Cipro.


Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: February 19, 2014
Date Started: April 2014
Date Completion: April 2018
Last Updated: April 17, 2017
Last Verified: April 2017