HIVPhase 3NCT02068846
BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent
A Phase 3 study testing Ciprofloxacin in people with HIV and Salivary Gland Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Salivary Gland Disease, Benign Lymphoepithelial Lesion
- What is being tested?
- Ciprofloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jan 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV positive with Salivary Gland Disease
- Ability to read and understand English
Who cannot join
- 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
Show all 10Show fewer
- Current use of phenytoin
- Current use of glyburide
- Current use of methotrexate
- Severe renal impairment (known creatinine clearance < 30 or on dialysis)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of North Carolina School of Dentistry
Chapel Hill, North Carolina, 27599
About this study
Official title: BK Virus in Salivary Gland Disease
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.
Read the 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.
- Conditions
- HIV, Salivary Gland Disease, Benign Lymphoepithelial Lesion
- Being tested
- Ciprofloxacin, Placebo
- Keywords
- HIV, Salivary Gland Disease, Benign Lymphoepithelial Lesion, BK Polyomavirus
- Medical subject headings
- Salivary Gland Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
Also called Cipro
Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.
PlaceboDrug
Also called Sugar pill
Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin | Active comparator | Active treatment twice daily for 28 days Receives: Drug: Ciprofloxacin |
| Placebo | Placebo comparator | Placebo treatment twice daily for 28 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 12
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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"
Measured: 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"
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Jennifer Webster-Cyriaque, DDS, PhD, Principal investigator, The University of North Carolina School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068846
- Sponsor's protocol ID
- 12-0036
- Other IDs
- 1R21DE023046-01A1
- Status last verified
- Jun 2019
- First submitted
- 19 Feb 2014
- Last updated
- 11 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BK Virus in Salivary Gland Disease
- ClinicalTrials.gov ID
- NCT02068846
- Acronym / sponsor ID
- 12-0036
- Conditions
- HIV, Salivary Gland Disease, Benign Lymphoepithelial Lesion
- Keywords
- HIV, Salivary Gland Disease, Benign Lymphoepithelial Lesion, BK Polyomavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Apr 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Posted 11 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin | Active comparator | Drug: CiprofloxacinActive treatment twice daily for 28 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo treatment twice daily for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV positive with Salivary Gland Disease
- Ability to read and understand English
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprofloxacinAlso: CiproOver encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days. | Drug | Ciprofloxacin |
| PlaceboAlso: Sugar pillPlacebo will over encapsulated to match active treatment, taken twice daily for 28 days. | Drug | Placebo |
Primary outcome
BK Viral Status in Saliva at Week 4
Time frame: 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
Time frame: 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.
4 secondary outcomes
Unstimulated Salivary Flow Rate at Week 4
Time frame: Week 4
Unstimulated Salivary Flow Rate at Week 12
Time frame: Week 12
Number of Participants Reporting Dry Mouth "Yes/No" at Week 4
Time frame: Week 4
Number of Participants Reporting Dry Mouth "Yes/No" at Week 12
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Webster-Cyriaque, DDS, PhD principal investigator
The University of North Carolina School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ciprofloxacin in people with HIV and Salivary Gland Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BK Viral Status in Saliva at Week 4 (time frame: Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.