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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
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: March 5, 2014
Last verified: March 2014
  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:


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: July 2014
Estimated Primary Completion Date: July 2014 (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
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
Investigators
Principal Investigator: Jennifer Webster-Cyriaque, DDS, PhD The University of North Carolina School of Dentistry
  More Information

No publications provided

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: March 5, 2014
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
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014