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

HIV Clinical Trial

Official title:

BK Virus in Salivary Gland Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068846
• Other study ID #: 12-0036
• Secondary ID: 1R21DE023046-01A
• Status: Completed
• Phase: Phase 3
• Start date: April 2014
• Est. completion date: January 2016

Study information

• Verified date: June 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Benign Lymphoepithelial Lesion
• HIV
• Salivary Gland Disease
• Salivary Gland Diseases

Intervention

Drug:
• Ciprofloxacin
Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.
• Placebo
Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.

Locations

Country	Name	City	State
United States	The University of North Carolina School of Dentistry	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Unstimulated Salivary Flow Rate at 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.	Week 4
Secondary	Unstimulated Salivary Flow Rate at 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.	Week 12
Secondary	Number of Participants Reporting Dry Mouth "Yes/No" at Week 4	Participants were asked "Have you noticed any change in your salivary glands or in the dryness of your mouth"	Week 4
Secondary	Number of Participants Reporting Dry Mouth "Yes/No" at Week 12	Participants were asked "Have you noticed any change in your salivary glands or in the dryness of your mouth"	Week 12