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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02068846
First Posted: February 21, 2014
Last Update Posted: April 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]
    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 ]
    It will be determine whether salivary gland function is improved or restored with the administration of Cipro.


Enrollment: 53
Study Start Date: April 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068846


Locations
United States, North Carolina
The University of North Carolina School of Dentistry
Chapel Hill, North Carolina, United States, 27599
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: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02068846     History of Changes
Other Study ID Numbers: 12-0036
1R21DE023046-01A1 ( U.S. NIH Grant/Contract )
First Submitted: February 19, 2014
First Posted: February 21, 2014
Last Update Posted: April 18, 2017
Last Verified: April 2017

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