Trial Outcomes & Findings for BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent (NCT NCT02068846)
NCT ID: NCT02068846
Last Updated: 2019-07-11
Results Overview
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.
COMPLETED
PHASE3
17 participants
Week 4
2019-07-11
Participant Flow
Participant milestones
| Measure |
Ciprofloxacin
Active treatment twice daily for 28 days
Ciprofloxacin: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.
|
Placebo
Placebo treatment twice daily for 28 days
Placebo: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data were not analyzed for one participant who discontinued
Baseline characteristics by cohort
| Measure |
Ciprofloxacin
n=9 Participants
Active treatment twice daily for 28 days
Ciprofloxacin: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.
|
Placebo
n=8 Participants
Placebo treatment twice daily for 28 days
Placebo: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.6 years
n=9 Participants
|
52.3 years
n=8 Participants
|
52.5 years
n=17 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=9 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=9 Participants
|
7 Participants
n=8 Participants
|
14 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
White non-Hispanic
|
3 Participants
n=9 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=9 Participants
|
4 Participants
n=8 Participants
|
9 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=9 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=9 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=17 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=17 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=9 Participants
|
8 Participants
n=8 Participants
|
17 Participants
n=17 Participants
|
|
BK Virus Status in Saliva
BK Virus positive
|
8 Participants
n=9 Participants • Data were not analyzed for one participant who discontinued
|
2 Participants
n=7 Participants • Data were not analyzed for one participant who discontinued
|
10 Participants
n=16 Participants • Data were not analyzed for one participant who discontinued
|
|
BK Virus Status in Saliva
BK Virus negative
|
1 Participants
n=9 Participants • Data were not analyzed for one participant who discontinued
|
5 Participants
n=7 Participants • Data were not analyzed for one participant who discontinued
|
6 Participants
n=16 Participants • Data were not analyzed for one participant who discontinued
|
|
Unstimulated Salivary Flow Rate
Normal salivary function
|
4 Participants
n=9 Participants • Data not collected because participant missed scheduled visit
|
1 Participants
n=7 Participants • Data not collected because participant missed scheduled visit
|
5 Participants
n=16 Participants • Data not collected because participant missed scheduled visit
|
|
Unstimulated Salivary Flow Rate
Salivary Hypofunction
|
5 Participants
n=9 Participants • Data not collected because participant missed scheduled visit
|
6 Participants
n=7 Participants • Data not collected because participant missed scheduled visit
|
11 Participants
n=16 Participants • Data not collected because participant missed scheduled visit
|
PRIMARY outcome
Timeframe: Week 4Population: Two participants withdrew prior to 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.
Outcome measures
| Measure |
Ciprofloxacin
n=8 Participants
Active treatment twice daily for 28 days
Ciprofloxacin: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.
|
Placebo
n=7 Participants
Placebo treatment twice daily for 28 days
Placebo: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.
|
|---|---|---|
|
BK Viral Status in Saliva at Week 4
BK Virus positive
|
3 Participants
|
6 Participants
|
|
BK Viral Status in Saliva at Week 4
BK Virus negative
|
5 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Two participants withdrew prior to 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.
Outcome measures
| Measure |
Ciprofloxacin
n=8 Participants
Active treatment twice daily for 28 days
Ciprofloxacin: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.
|
Placebo
n=7 Participants
Placebo treatment twice daily for 28 days
Placebo: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.
|
|---|---|---|
|
BK Viral Status in Saliva at Week 12
BK Virus positive
|
3 Participants
|
4 Participants
|
|
BK Viral Status in Saliva at Week 12
BK Virus negative
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 4Population: Two participants withdrew prior to Week 4 and one participant did not perform salivary flow collection.
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.
Outcome measures
| Measure |
Ciprofloxacin
n=8 Participants
Active treatment twice daily for 28 days
Ciprofloxacin: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.
|
Placebo
n=6 Participants
Placebo treatment twice daily for 28 days
Placebo: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.
|
|---|---|---|
|
Unstimulated Salivary Flow Rate at Week 4
Normal salivary function
|
3 Participants
|
1 Participants
|
|
Unstimulated Salivary Flow Rate at Week 4
Salivary hypofunction
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Two participants withdrew prior to Week 4 and two participants did not perform salivary flow collection.
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.
Outcome measures
| Measure |
Ciprofloxacin
n=7 Participants
Active treatment twice daily for 28 days
Ciprofloxacin: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.
|
Placebo
n=6 Participants
Placebo treatment twice daily for 28 days
Placebo: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.
|
|---|---|---|
|
Unstimulated Salivary Flow Rate at Week 12
Normal salivary function
|
3 Participants
|
1 Participants
|
|
Unstimulated Salivary Flow Rate at Week 12
Salivary hypofunction
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 4Participants were asked "Have you noticed any change in your salivary glands or in the dryness of your mouth"
Outcome measures
| Measure |
Ciprofloxacin
n=8 Participants
Active treatment twice daily for 28 days
Ciprofloxacin: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.
|
Placebo
n=7 Participants
Placebo treatment twice daily for 28 days
Placebo: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.
|
|---|---|---|
|
Number of Participants Reporting Dry Mouth "Yes/No" at Week 4
Change = Yes
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Dry Mouth "Yes/No" at Week 4
Change = No
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 12Participants were asked "Have you noticed any change in your salivary glands or in the dryness of your mouth"
Outcome measures
| Measure |
Ciprofloxacin
n=8 Participants
Active treatment twice daily for 28 days
Ciprofloxacin: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.
|
Placebo
n=7 Participants
Placebo treatment twice daily for 28 days
Placebo: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.
|
|---|---|---|
|
Number of Participants Reporting Dry Mouth "Yes/No" at Week 12
Change = Yes
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Dry Mouth "Yes/No" at Week 12
Change = No
|
6 Participants
|
6 Participants
|
Adverse Events
Ciprofloxacin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ciprofloxacin
n=9 participants at risk
Active treatment twice daily for 28 days
Ciprofloxacin: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.
|
Placebo
n=8 participants at risk
Placebo treatment twice daily for 28 days
Placebo: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
Additional Information
Jennifer Webster-Cyriaque, DDS, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place