A Phase 3 interventional study of Ciprofloxacin and Placebo in HIV, Salivary Gland Disease and Benign Lymphoepithelial Lesion, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-11.
Sponsored by University of North Carolina, Chapel Hill · Phase 3, Interventional, and Treatment
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.
University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Active treatment twice daily for 28 days
Drug: Ciprofloxacin
Placebo treatment twice daily for 28 days
Drug: Placebo
Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.
Also known as: Cipro
Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.
Also known as: Sugar pill
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
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
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
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
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
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
| Milestone | Ciprofloxacin | Placebo |
|---|---|---|
| Started | 9 | 8 |
| Completed | 8 | 7 |
| Not completed | 1 | 1 |
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.
| Participants | Ciprofloxacin | Placebo |
|---|---|---|
| BK Virus positive | 3 | 6 |
| BK Virus negative | 5 | 1 |
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.
| Participants | Ciprofloxacin | Placebo |
|---|---|---|
| BK Virus positive | 3 | 4 |
| BK Virus negative | 5 | 3 |
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.
| Participants | Ciprofloxacin | Placebo |
|---|---|---|
| Normal salivary function | 3 | 1 |
| Salivary hypofunction | 5 | 5 |
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.
| Participants | Ciprofloxacin | Placebo |
|---|---|---|
| Normal salivary function | 3 | 1 |
| Salivary hypofunction | 4 | 5 |
Participants were asked "Have you noticed any change in your salivary glands or in the dryness of your mouth"
| Participants | Ciprofloxacin | Placebo |
|---|---|---|
| Change = Yes | 2 | 1 |
| Change = No | 6 | 6 |
Participants were asked "Have you noticed any change in your salivary glands or in the dryness of your mouth"
| Participants | Ciprofloxacin | Placebo |
|---|---|---|
| Change = Yes | 2 | 1 |
| Change = No | 6 | 6 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ciprofloxacin | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) |
| Placebo | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Event | Ciprofloxacin | Placebo |
|---|---|---|
| RashSkin and subcutaneous tissue disorders | 1/9 | 0/8 |
| Age, Continuous(years) | Ciprofloxacin | Placebo | Total |
|---|---|---|---|
| Mean | 52.6 (37 to 69) | 52.3 (49 to 57) | 52.5 (37 to 69) |
| Sex: Female, Male(Participants) | Ciprofloxacin | Placebo | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 7 | 7 | 14 |
| Race/Ethnicity, Customized(Participants) | Ciprofloxacin | Placebo | Total |
|---|---|---|---|
| White non-Hispanic | 3 | 1 | 4 |
| Black or African American | 5 | 4 | 9 |
| Asian | 0 | 1 | 1 |
| Hispanic or Latino | 0 | 2 | 2 |
| Other | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Ciprofloxacin | Placebo | Total |
|---|---|---|---|
| United States | 9 | 8 | 17 |
| BK Virus Status in Saliva(Participants) | Ciprofloxacin | Placebo | Total |
|---|---|---|---|
| BK Virus positive | 8 | 2 | 10 |
| BK Virus negative | 1 | 5 | 6 |
| Unstimulated Salivary Flow Rate(Participants) | Ciprofloxacin | Placebo | Total |
|---|---|---|---|
| Normal salivary function | 4 | 1 | 5 |
| Salivary Hypofunction | 5 | 6 | 11 |
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Salivary Gland Diseases
University of North Carolina, Chapel Hill