Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02068846
Other study ID # 12-0036
Secondary ID 1R21DE023046-01A
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2014
Est. completion date January 2016

Study information

Verified date June 2019
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- HIV positive with Salivary Gland Disease

- Ability to read and understand English

Exclusion Criteria:

- 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

- Current use of phenytoin

- Current use of glyburide

- Current use of methotrexate

- Severe renal impairment (known creatinine clearance < 30 or on dialysis)

Study Design


Intervention

Drug:
Ciprofloxacin
Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.
Placebo
Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.

Locations

Country Name City State
United States The University of North Carolina School of Dentistry Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Week 4
Primary 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. Week 12
Secondary 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. Week 4
Secondary 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. Week 12
Secondary 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" Week 4
Secondary 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" Week 12
See also
  Status Clinical Trial Phase
Recruiting NCT06162897 - Case Management Dyad N/A
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT02528773 - Efficacy of ART to Interrupt HIV Transmission Networks
Active, not recruiting NCT05454839 - Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
Recruiting NCT05322629 - Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women N/A
Completed NCT02579135 - Reducing HIV Risk Among Adolescents: Evaluating Project HEART N/A
Active, not recruiting NCT01790373 - Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence N/A
Not yet recruiting NCT06044792 - The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
Completed NCT04039217 - Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM Phase 4
Active, not recruiting NCT04519970 - Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK) N/A
Completed NCT04124536 - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women N/A
Recruiting NCT05599581 - Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health N/A
Active, not recruiting NCT04588883 - Strengthening Families Living With HIV in Kenya N/A
Completed NCT02758093 - Speed of Processing Training in Adults With HIV N/A
Completed NCT02500446 - Dolutegravir Impact on Residual Replication Phase 4
Completed NCT03805451 - Life Steps for PrEP for Youth N/A
Active, not recruiting NCT03902431 - Translating the ABCS Into HIV Care N/A
Completed NCT00729391 - Women-Focused HIV Prevention in the Western Cape Phase 2/Phase 3
Recruiting NCT05736588 - Elimisha HPV (Human Papillomavirus) N/A
Recruiting NCT03589040 - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant Phase 2