Back to resultsBK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent
Primary Purpose
HIV, Salivary Gland Disease, Benign Lymphoepithelial Lesion
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ciprofloxacin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for HIV focused on measuring HIV, Salivary Gland Disease, Benign Lymphoepithelial Lesion, BK Polyomavirus
Eligibility 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)
Sites / Locations
- The University of North Carolina School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ciprofloxacin
Placebo
Arm Description
Active treatment twice daily for 28 days
Placebo treatment twice daily for 28 days
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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"
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"
Full Information
NCT ID
NCT02068846
First Posted
February 19, 2014
Last Updated
June 17, 2019
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
1. Study Identification
Unique Protocol Identification Number
NCT02068846
Brief Title
BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent
Official Title
BK Virus in Salivary Gland Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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. It is expected that patients with HIV+SGD+ will have elevated oral BK polyomavirus viral loads and will benefit from Ciprofloxacin.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Salivary Gland Disease, Benign Lymphoepithelial Lesion
Keywords
HIV, Salivary Gland Disease, Benign Lymphoepithelial Lesion, BK Polyomavirus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ciprofloxacin
Arm Type
Active Comparator
Arm Description
Active treatment twice daily for 28 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo treatment twice daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Other Intervention Name(s)
Cipro
Intervention Description
Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.
Primary Outcome Measure Information:
Title
BK Viral Status in Saliva at Week 4
Description
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.
Time Frame
Week 4
Title
BK Viral Status in Saliva at Week 12
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Unstimulated Salivary Flow Rate at Week 4
Description
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.
Time Frame
Week 4
Title
Unstimulated Salivary Flow Rate at Week 12
Description
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.
Time Frame
Week 12
Title
Number of Participants Reporting Dry Mouth "Yes/No" at Week 4
Description
Participants were asked "Have you noticed any change in your salivary glands or in the dryness of your mouth"
Time Frame
Week 4
Title
Number of Participants Reporting Dry Mouth "Yes/No" at Week 12
Description
Participants were asked "Have you noticed any change in your salivary glands or in the dryness of your mouth"
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Webster-Cyriaque, DDS, PhD
Organizational Affiliation
The University of North Carolina School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of North Carolina School of Dentistry
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Learn more about this trial
BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent
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