NCT02068846

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. It is expected that patients with HIV+SGD+ will have elevated oral BK polyomavirus viral loads and will benefit from Ciprofloxacin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_3 hiv

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_3 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

July 11, 2019

Completed
Last Updated

July 11, 2019

Status Verified

June 1, 2019

Enrollment Period

1.8 years

First QC Date

February 19, 2014

Results QC Date

June 17, 2019

Last Update Submit

June 17, 2019

Conditions

HIVSalivary Gland DiseaseBenign Lymphoepithelial Lesion

Keywords

HIVSalivary Gland DiseaseBenign Lymphoepithelial LesionBK Polyomavirus

Outcome Measures

Primary Outcomes (2)

  • BK Viral Status in Saliva at Week 4

    Oral fluids will be assessed for evidence of BK Virus replication to determine whether Cipro administration inhibits BK Virus replication in participants with HIVSGD. Oral fluids will be assessed by real-time PCR to determine BK Virus status as positive or negative.

    Week 4

  • BK Viral Status in Saliva at Week 12

    Oral fluids will be assessed for evidence of BK Virus replication to determine whether Cipro administration inhibits BK Virus replication in participants with HIVSGD. Oral fluids will be assessed by real-time PCR to determine BK Virus status as positive or negative.

    Week 12

Secondary Outcomes (4)

  • Unstimulated Salivary Flow Rate at Week 4

    Week 4

  • Unstimulated Salivary Flow Rate at Week 12

    Week 12

  • Number of Participants Reporting Dry Mouth "Yes/No" at Week 4

    Week 4

  • Number of Participants Reporting Dry Mouth "Yes/No" at Week 12

    Week 12

Study Arms (2)

Ciprofloxacin

ACTIVE COMPARATOR

Active treatment twice daily for 28 days

Drug: Ciprofloxacin

Placebo

PLACEBO COMPARATOR

Placebo treatment twice daily for 28 days

Drug: Placebo

Interventions

CiprofloxacinDRUG

Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.

Also known as: Cipro
Ciprofloxacin
PlaceboDRUG

Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.

Also known as: Sugar pill
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of North Carolina School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Salivary Gland Diseases

Interventions

CiprofloxacinSugars

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCarbohydrates

Results Point of Contact

Title
Jennifer Webster-Cyriaque, DDS, PhD
Organization
University of North Carolina at Chapel Hill
jwebster@email.unc.edu
(919) 537-3492

Study Officials

  • Jennifer Webster-Cyriaque, DDS, PhD

    The University of North Carolina School of Dentistry

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 21, 2014

Study Start

April 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

July 11, 2019

Results First Posted

July 11, 2019

Record last verified: 2019-06

Locations

US(1)