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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Institute of Dental and Craniofacial Research (NIDCR)
• Treatments: Ciprofloxacin

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)