CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 17 enrolled
Drug / intervention
Ciprofloxacin +1 moredrug
Likely dose
Ciprofloxacin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02068846
NCT02068846Phase 3Completed
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BK Virus in Salivary Gland Disease

University of North Carolina, Chapel Hill·interventional·Posted Feb 21, 2014·Updated Jul 11, 2019

In Brief

A Phase 3 clinical trial evaluating Ciprofloxacin and Placebo for HIV and 2 related conditions. Completed, enrolled 17 participants across 1 site.

Detailed 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). 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, Salivary Gland Disease, Benign Lymphoepithelial Lesion
CountriesUnited States
CollaboratorsNational Institute of Dental and Craniofacial Research (NIDCR)

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 21, 2014
Enrollment StartApr 1, 2014
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.4 years ago

Interventions

Ciprofloxacindrug

Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.

Placebodrug

Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.