NCT00659971

Phase 2B Dose-Ranging Study of PAC113 Mouthrinse in HIV Seropositive Individuals With Oral Candidiasis

A Phase 2B Dose-Ranging Study of PAC113 Mouthrinse for Clinical and Microbial Evaluation in HIV Seropositive Individuals With Oral Candidiasis to Establish the Optimal Dose of PAC113

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: Pacgen Biopharmaceuticals Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the optimal dose of PAC113 mouthrinse for treatment of oral candidiasis in HIV seropositive patients.

Detailed description

This is a randomized, examiner-blinded, positive-controlled, parallel design clinical trial, which features 4 treatment arms. Forty-five (45)\* HIV positive subjects per treatment arm will be recruited for 180 subjects total. The study includes 5 visits: a screening visit, a 14-day treatment phase with a baseline visit on Day 1, a Day 7 visit, a post-treatment visit 5 days after the last dose, and follow-up visit. During the screening visit subjects will be assessed for study eligibility. Eligible subjects will be randomized to 1 of the following treatment arms: A. 0.15% PAC-113 mouthrinse (5 mL 4 times daily \[q.i.d.\]); B. 0.075% PAC-113 mouthrinse (5 mL q.i.d.); C. 0.0375% PAC-113 mouthrinse (5 mL q.i.d.); D. Nystatin oral suspension (100,000 units/mL; 5 mL q.i.d.) Subjects will be evaluated clinically for safety and severity of clinical signs and symptoms of oral candidiasis at baseline (Day 1), Day 7, Day 19 (5 days post-treatment) and Day 28 (follow-up visit). Subjects will also have a microbiological analysis performed at screening, and at Days 7, 19 and 28.

Conditions

• Oral Candidiasis

Interventions

Type	Name	Description
DRUG	PAC113	PAC113 mouthrinse 0.15%; 0.075%; 0.0375% QID for 14 days

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2008-04-17
• Last updated: 2008-06-26

Locations

1 site across 1 country: United States