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Antiviral

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

Phase 3
Waitlist Available
Led By Jennifer Webster-Cyriaque, DDS, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
All Individual Drugs Already Approved
Approved for 40 Other Conditions
Pivotal Trial

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.

Eligible Conditions
  • Salivary Gland Disease
  • HIV/AIDS
  • Benign Lymphoepithelial Lesion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
BK Viral Status in Saliva at Week 12
BK Viral Status in Saliva at Week 4
Secondary study objectives
Number of Participants Reporting Dry Mouth "Yes/No" at Week 12
Number of Participants Reporting Dry Mouth "Yes/No" at Week 4
Unstimulated Salivary Flow Rate at Week 12
+1 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 40 Other Conditions
This treatment demonstrated efficacy for 40 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: CiprofloxacinActive Control1 Intervention
Active treatment twice daily for 28 days
Group II: PlaceboPlacebo Group1 Intervention
Placebo treatment twice daily for 28 days

Find a Location

Who is running the clinical trial?

National Institute of Dental and Craniofacial Research (NIDCR)NIH
308 Previous Clinical Trials
850,259 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,569 Previous Clinical Trials
4,319,690 Total Patients Enrolled
Jennifer Webster-Cyriaque, DDS, PhDPrincipal InvestigatorThe University of North Carolina School of Dentistry
~1 spots leftby Jan 2026
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