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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Dos

Brief 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 Summary:

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.

Sponsor: Pacgen Biopharmaceuticals Corporation

Current Primary Outcome: Eliminating or reducing clinical signs and symptoms of oral Candida infections. [ Time Frame: Day 19 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To evaluate the microbiological response of Candida to different concentrations of PAC-113. [ Time Frame: Day 19 ]

Original Secondary Outcome: Same as current

Information By: Pacgen Biopharmaceuticals Corporation

Dates:
Date Received: March 18, 2008
Date Started: January 2008
Date Completion:
Last Updated: June 25, 2008
Last Verified: June 2008