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

BK Virus in Salivary Gland Disease

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. It is expected that patients with HIV+SGD+ will have elevated oral BK polyomavirus viral loads and will benefit from Ciprofloxacin.

Study Overview

• Status: Completed
• Conditions: HIV; Salivary Gland Disease; Benign Lymphoepithelial Lesion
• Intervention / Treatment: Drug: Ciprofloxacin; Drug: Placebo

Detailed Description

The study duration is 12 weeks with a baseline visit, a visit at 4 weeks and a visit at 12 weeks. At baseline participants are randomized to Ciprofloxacin or placebo and take the drug or placebo for 28 days. At subsequent visits BK polyomavirus presence and salivary gland function will be assessed.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • The University of North Carolina School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ciprofloxacin; Active treatment twice daily for 28 days	Drug: Ciprofloxacin; Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.; Other Names: Cipro
PLACEBO_COMPARATOR: Placebo; Placebo treatment twice daily for 28 days	Drug: Placebo; Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.; Other Names: Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BK Viral Status in Saliva at Week 4	Oral fluids will be assessed for evidence of BK Virus replication to determine whether Cipro administration inhibits BK Virus replication in participants with HIVSGD. Oral fluids will be assessed by real-time PCR to determine BK Virus status as positive or negative.	Week 4
BK Viral Status in Saliva at Week 12	Oral fluids will be assessed for evidence of BK Virus replication to determine whether Cipro administration inhibits BK Virus replication in participants with HIVSGD. Oral fluids will be assessed by real-time PCR to determine BK Virus status as positive or negative.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unstimulated Salivary Flow Rate at Week 4	To determine whether salivary gland function is improved or restored with the administration of Cipro in participants with HIVSGD. After sitting at rest for 1 minute, participants collect drool using 50-mL conical tubes. The 5-minute unstimulated whole saliva flow rate recorded and collected. Salivary hypofunction is defined as unstimulated whole saliva flow rate ≤ 0.1 mL/min. Normal salivary function is defined as > 0.1 mL/min.	Week 4
Unstimulated Salivary Flow Rate at Week 12	To determine whether salivary gland function is improved or restored with the administration of Cipro in participants with HIVSGD. After sitting at rest for 1 minute, participants collect drool using 50-mL conical tubes. The 5-minute unstimulated whole saliva flow rate recorded and collected. Salivary hypofunction is defined as unstimulated whole saliva flow rate ≤0.1 mL/min. Normal salivary function is defined as >0.1 mL/min.	Week 12
Number of Participants Reporting Dry Mouth "Yes/No" at Week 4	Participants were asked "Have you noticed any change in your salivary glands or in the dryness of your mouth"	Week 4
Number of Participants Reporting Dry Mouth "Yes/No" at Week 12	Participants were asked "Have you noticed any change in your salivary glands or in the dryness of your mouth"	Week 12

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Jennifer Webster-Cyriaque, DDS, PhD, The University of North Carolina School of Dentistry

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2014
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: February 19, 2014
• First Submitted That Met QC Criteria: February 20, 2014
• First Posted (ESTIMATE): February 21, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: HIV; Salivary Gland Disease; Benign Lymphoepithelial Lesion; BK Polyomavirus
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: 12-0036; 1R21DE023046-01A1 (NIH)