BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent
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| ClinicalTrials.gov Identifier: NCT02068846 |
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Recruitment Status :
Active, not recruiting
First Posted : February 21, 2014
Last Update Posted : April 18, 2017
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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
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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. We expect that patients with HIV+SGD+ will have elevated oral BK polyomavirus viral loads and will benefit from Ciprofloxacin.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Salivary Gland Disease Benign Lymphoepithelial Lesion | Drug: Ciprofloxacin Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 53 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | BK Virus in Salivary Gland Disease |
| Study Start Date : | April 2014 |
| Estimated Primary Completion Date : | April 2018 |
| Estimated Study Completion Date : | April 2018 |
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| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Ciprofloxacin
over encapsulated, 500mg bid, 28 days
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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 |
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Placebo Comparator: Placebo
Over encapsulated to match active comparator, bid, 28 days
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Drug: Placebo |
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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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)
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 |
| 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 Posted: | February 21, 2014 Key Record Dates |
| Last Update Posted: | April 18, 2017 |
| Last Verified: | April 2017 |
Keywords provided by University of North Carolina, Chapel Hill:
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HIV Salivary Gland Disease Benign Lymphoepithelial Lesion BK Polyomavirus |
Additional relevant MeSH terms:
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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 |