Benign Lymphoepithelial Lesion, HIV, Salivary Gland Disease
Conditions
Keywords
HIV, Salivary Gland Disease, Benign Lymphoepithelial Lesion, BK Polyomavirus
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.
Detailed 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.
Interventions
DRUGCiprofloxacin
Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.
DRUGPlacebo
Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BK Viral Status in Saliva at Week 4 | 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. |
| BK Viral Status in Saliva at Week 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| Unstimulated Salivary Flow Rate at Week 4 | 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. |
| Unstimulated Salivary Flow Rate at Week 12 | 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. |
| Number of Participants Reporting Dry Mouth Yes/No at Week 4 | Week 4 | Participants were asked Have you noticed any change in your salivary glands or in the dryness of your mouth |
| Number of Participants Reporting Dry Mouth Yes/No at Week 12 | Week 12 | Participants were asked Have you noticed any change in your salivary glands or in the dryness of your mouth |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ciprofloxacin Active treatment twice daily for 28 days
Ciprofloxacin: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days. | 9 |
| Placebo Placebo treatment twice daily for 28 days
Placebo: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days. | 8 |
| Total | 17 |
Baseline characteristics
| Characteristic | Ciprofloxacin | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 52.6 years | 52.3 years | 52.5 years |
| BK Virus Status in Saliva BK Virus negative | 1 Participants | 5 Participants | 6 Participants |
| BK Virus Status in Saliva BK Virus positive | 8 Participants | 2 Participants | 10 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White non-Hispanic | 3 Participants | 1 Participants | 4 Participants |
| Region of Enrollment United States | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 14 Participants |
| Unstimulated Salivary Flow Rate Normal salivary function | 4 Participants | 1 Participants | 5 Participants |
| Unstimulated Salivary Flow Rate Salivary Hypofunction | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 8 |
| other Total, other adverse events | 1 / 9 | 0 / 8 |
| serious Total, serious adverse events | 0 / 9 | 0 / 8 |
Outcome results
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.
Time frame: Week 12
Population: Two participants withdrew prior to Week 4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ciprofloxacin | BK Viral Status in Saliva at Week 12 | BK Virus positive | 3 Participants |
| Ciprofloxacin | BK Viral Status in Saliva at Week 12 | BK Virus negative | 5 Participants |
| Placebo | BK Viral Status in Saliva at Week 12 | BK Virus positive | 4 Participants |
| Placebo | BK Viral Status in Saliva at Week 12 | BK Virus negative | 3 Participants |
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.
Time frame: Week 4
Population: Two participants withdrew prior to Week 4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ciprofloxacin | BK Viral Status in Saliva at Week 4 | BK Virus positive | 3 Participants |
| Ciprofloxacin | BK Viral Status in Saliva at Week 4 | BK Virus negative | 5 Participants |
| Placebo | BK Viral Status in Saliva at Week 4 | BK Virus positive | 6 Participants |
| Placebo | BK Viral Status in Saliva at Week 4 | BK Virus negative | 1 Participants |
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
Time frame: Week 12
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ciprofloxacin | Number of Participants Reporting Dry Mouth Yes/No at Week 12 | Change = Yes | 2 Participants |
| Ciprofloxacin | Number of Participants Reporting Dry Mouth Yes/No at Week 12 | Change = No | 6 Participants |
| Placebo | Number of Participants Reporting Dry Mouth Yes/No at Week 12 | Change = Yes | 1 Participants |
| Placebo | Number of Participants Reporting Dry Mouth Yes/No at Week 12 | Change = No | 6 Participants |
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
Time frame: Week 4
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ciprofloxacin | Number of Participants Reporting Dry Mouth Yes/No at Week 4 | Change = Yes | 2 Participants |
| Ciprofloxacin | Number of Participants Reporting Dry Mouth Yes/No at Week 4 | Change = No | 6 Participants |
| Placebo | Number of Participants Reporting Dry Mouth Yes/No at Week 4 | Change = Yes | 1 Participants |
| Placebo | Number of Participants Reporting Dry Mouth Yes/No at Week 4 | Change = No | 6 Participants |
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.
Time frame: Week 12
Population: Two participants withdrew prior to Week 4 and two participants did not perform salivary flow collection.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ciprofloxacin | Unstimulated Salivary Flow Rate at Week 12 | Normal salivary function | 3 Participants |
| Ciprofloxacin | Unstimulated Salivary Flow Rate at Week 12 | Salivary hypofunction | 4 Participants |
| Placebo | Unstimulated Salivary Flow Rate at Week 12 | Normal salivary function | 1 Participants |
| Placebo | Unstimulated Salivary Flow Rate at Week 12 | Salivary hypofunction | 5 Participants |
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.
Time frame: Week 4
Population: Two participants withdrew prior to Week 4 and one participant did not perform salivary flow collection.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ciprofloxacin | Unstimulated Salivary Flow Rate at Week 4 | Normal salivary function | 3 Participants |
| Ciprofloxacin | Unstimulated Salivary Flow Rate at Week 4 | Salivary hypofunction | 5 Participants |
| Placebo | Unstimulated Salivary Flow Rate at Week 4 | Normal salivary function | 1 Participants |
| Placebo | Unstimulated Salivary Flow Rate at Week 4 | Salivary hypofunction | 5 Participants |