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

This study is currently recruiting participants. (see Contacts and Locations)

Verified April 2016 by University of North Carolina, Chapel Hill

Sponsor:

Collaborator:

National Institute of Dental and Craniofacial Research (NIDCR)

Information provided by (Responsible Party):

Jennifer Webster-Cyriaque, DDS, PhD, University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT02068846

First received: February 19, 2014

Last updated: April 12, 2016

Last verified: April 2016

History of Changes

Purpose

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.

Condition	Intervention	Phase
HIV Salivary Gland Disease Benign Lymphoepithelial Lesion	Drug: Ciprofloxacin Drug: Placebo	Phase 3


Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Salivary Gland Disorders

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:

(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).

Secondary Outcome Measures:

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.


Estimated Enrollment:	20
Study Start Date:	February 2014
Estimated Study Completion Date:	September 2016
Estimated Primary Completion Date:	September 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Ciprofloxacin over encapsulated, 500mg bid, 28 days	Drug: Ciprofloxacin 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	Drug: Placebo

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02068846

Contacts


Contact: Jo-Ann A Blake, RDH, MPH	919 537-3361	jo-ann_blake@unc.edu
Contact: Jennifer Webster-Cyriaque, DDS, PhD

Locations


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

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators


Principal Investigator:	Jennifer Webster-Cyriaque, DDS, PhD	The University of North Carolina School of Dentistry

More Information


Responsible Party:	Jennifer Webster-Cyriaque, DDS, PhD, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT02068846 History of Changes
Other Study ID Numbers:	12-0036 1R21DE023046-01A1
Study First Received:	February 19, 2014
Last Updated:	April 12, 2016
Health Authority:	United States: Institutional Review Board United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:


HIV Salivary Gland Disease Benign Lymphoepithelial Lesion BK Polyomavirus

Additional relevant MeSH terms:


Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases Ciprofloxacin Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors	Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 26, 2016

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