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BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent
This study is ongoing, but not recruiting participants.
Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02068846
First received: February 19, 2014
Last updated: April 17, 2017
Last verified: April 2017
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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: 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| 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
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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
Please refer to this study by its ClinicalTrials.gov identifier: 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 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | February 19, 2014 |
| Last Updated: | April 17, 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 |
ClinicalTrials.gov processed this record on June 26, 2017