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

Completed · Phase 3 · Has a placebo group

Conditions studied: HIV, Salivary Gland Disease, Benign Lymphoepithelial Lesion

In brief

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.

Key facts

Study ID

NCT02068846

Run by

University of North Carolina, Chapel Hill

People needed

17

Starts

2014-04-01

Expected to finish

2016-01-01

Last updated by the study team

2019-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV positive with Salivary Gland Disease
• Ability to read and understand English

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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