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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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HIV Salivary Gland Disease Benign Lymphoepithelial Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ciprofloxacin

Active treatment twice daily for 28 days

Group Type ACTIVE_COMPARATOR

Ciprofloxacin

Intervention Type DRUG

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

Placebo

Placebo treatment twice daily for 28 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Ciprofloxacin

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Cipro Sugar pill

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No