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NCT Number: NCT02068846

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

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.

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Key information

Conditions

HIV Benign Lymphoepithelial Lesion Mouth Diseases Salivary Gland Disease Salivary Gland Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The University of North Carolina School of Dentistry

Chapel Hill, North Carolina, 27599, United States

About this study

The study duration is 12 weeks with a baseline visit, a visit at 4 weeks and a visit at 12 weeks. At baseline participants are randomized to Ciprofloxacin or placebo and take the drug or placebo for 28 days. At subsequent visits BK polyomavirus presence and salivary gland function will be assessed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ciprofloxacin

Drug

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

Other names: Cipro

Placebo

Drug

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

Other names: Sugar pill

Primary outcomes

  1. BK Viral Status in Saliva at Week 4

    Time frame: 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.

  2. BK Viral Status in Saliva at Week 12

    Time frame: 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.

Secondary outcomes

  1. Unstimulated Salivary Flow Rate at Week 4

    Time frame: Week 4

    To determine whether salivary gland function is improved or restored with the administration of Cipro in participants with HIVSGD. After sitting at rest for 1 minute, participants collect drool using 50-mL conical tubes. The 5-minute unstimulated whole saliva flow rate recorded and collected. Salivary hypofunction is defined as unstimulated whole saliva flow rate ≤ 0.1 mL/min. Normal salivary function is defined as > 0.1 mL/min.

  2. Unstimulated Salivary Flow Rate at Week 12

    Time frame: Week 12

    To determine whether salivary gland function is improved or restored with the administration of Cipro in participants with HIVSGD. After sitting at rest for 1 minute, participants collect drool using 50-mL conical tubes. The 5-minute unstimulated whole saliva flow rate recorded and collected. Salivary hypofunction is defined as unstimulated whole saliva flow rate ≤0.1 mL/min. Normal salivary function is defined as >0.1 mL/min.

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

    Time frame: Week 4

    Participants were asked "Have you noticed any change in your salivary glands or in the dryness of your mouth"

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

    Time frame: Week 12

    Participants were asked "Have you noticed any change in your salivary glands or in the dryness of your mouth"

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

BK Virus in Salivary Gland Disease

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 21, 2014
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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