Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DE023046-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofloxacin | Active Comparator | Active treatment twice daily for 28 days |
|
| Placebo | Placebo Comparator | Placebo treatment twice daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin | Drug | Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Webster-Cyriaque, DDS, PhD | The University of North Carolina School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of North Carolina School of Dentistry | Chapel Hill | North Carolina | 27599 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ciprofloxacin | Active treatment twice daily for 28 days Ciprofloxacin: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days. |
| FG001 | Placebo | Placebo treatment twice daily for 28 days Placebo: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ciprofloxacin | Active treatment twice daily for 28 days Ciprofloxacin: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days. |
| BG001 | Placebo | Placebo treatment twice daily for 28 days Placebo: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Two participants withdrew prior to Week 4 | Posted | Count of Participants | Participants | Week 4 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ciprofloxacin | Active treatment twice daily for 28 days Ciprofloxacin: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Webster-Cyriaque, DDS, PhD | University of North Carolina at Chapel Hill | (919) 537-3492 | jwebster@email.unc.edu |
Not provided
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo will over encapsulated to match active treatment, taken twice daily for 28 days. |
|
|
| Week 4 |
| 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 |
| 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 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BK Virus Status in Saliva | Oral fluids will be assessed for evidence of BK Virus replication to determine whether Cipro administration inhibits BK Virus replication in participants with HIV associated salivary gland disease (HIVSGD). Oral fluids will be assessed by real-time polymerase chain reaction (PCR) to determine BK Virus status as positive or negative. | Data were not analyzed for one participant who discontinued | Count of Participants | Participants |
|
| Unstimulated Salivary Flow Rate | To determine salivary gland function at Baseline. 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. | Data not collected because participant missed scheduled visit | Count of Participants | Participants |
|
|
|
| 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. | Two participants withdrew prior to Week 4 | Posted | Count of Participants | Participants | 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. | Two participants withdrew prior to Week 4 and one participant did not perform salivary flow collection. | Posted | Count of Participants | Participants | 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. | Two participants withdrew prior to Week 4 and two participants did not perform salivary flow collection. | Posted | Count of Participants | Participants | 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" | Posted | Count of Participants | Participants | 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" | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Placebo | Placebo treatment twice daily for 28 days Placebo: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days. | 0 | 8 | 0 | 8 | 0 | 8 |
Not provided
Not provided
Not provided
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |