BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02068846|
Recruitment Status : Active, not recruiting
First Posted : February 21, 2014
Last Update Posted : April 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Salivary Gland Disease Benign Lymphoepithelial Lesion||Drug: Ciprofloxacin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||BK Virus in Salivary Gland Disease|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
Active Comparator: Ciprofloxacin
over encapsulated, 500mg bid, 28 days
20 (SGDHIV) Participants will be randomized to either Ciprofloxacin or a Placebo arm. Ciprofloxacin 500mg will be over encapsulated and taken 2x daily for 28days, Placebo will also be over encapsulated and taken 2x daily for 28days. This study is double blinded. Each study participant will be consented and be required to complete study questionnaires.
Other Name: Cipro
Placebo Comparator: Placebo
Over encapsulated to match active comparator, bid, 28 days
- (BK) Virus replication and shedding [ Time Frame: 12 weeks ]It has been determined that patients with (HIVSGD) shed high levels of (BK) Virus and have evidence of replicating (BK) Virus in their salivary gland tissues. Body fluids and salivary gland tissue will be assessed for evidence of (BK) Virus replication. It will be determine whether Cipro administration decreases (BK) Virus replication in patients with (HIVSGD).
- Salivary function [ Time Frame: 12 weeks ]It will be determine whether salivary gland function is improved or restored with the administration of Cipro.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068846
|United States, North Carolina|
|The University of North Carolina School of Dentistry|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Jennifer Webster-Cyriaque, DDS, PhD||The University of North Carolina School of Dentistry|