Phase 3
N=17
BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent
HIV · Salivary Gland Disease · Benign Lymphoepithelial Lesion
Bottom Line
View on ClinicalTrials.gov: NCT02068846 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: BK Viral Status in Saliva at Week 4 — 3; 6; 5; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ciprofloxacin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BK Viral Status in Saliva at Week 4 |
3; 6; 5; 1 | — |
| PRIMARY BK Viral Status in Saliva at Week 12 |
3; 4; 5; 3 | — |
| SECONDARY Unstimulated Salivary Flow Rate at Week 4 |
3; 1; 5; 5 | — |
| SECONDARY Unstimulated Salivary Flow Rate at Week 12 |
3; 1; 4; 5 | — |
| SECONDARY Number of Participants Reporting Dry Mouth "Yes/No" at Week 4 |
2; 1; 6; 6 | — |
| SECONDARY Number of Participants Reporting Dry Mouth "Yes/No" at Week 12 |
2; 1; 6; 6 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT02068846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.