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

NCT ID: NCT00659971

Last Updated: 2008-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 223 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-06-30

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 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

Keywords

oral candidiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

PAC113 0,15% mouthrinse

Group Type: EXPERIMENTAL

PAC113

Intervention Type: DRUG

PAC113 mouthrinse 0.15%; 0.075%; 0.0375% QID for 14 days

2

PAC113 0,075% mouthrinse

Group Type: EXPERIMENTAL

PAC113

Intervention Type: DRUG

PAC113 mouthrinse 0.15%; 0.075%; 0.0375% QID for 14 days

3

PAC113 0,0375% mouthrinse

Group Type: EXPERIMENTAL

PAC113

Intervention Type: DRUG

PAC113 mouthrinse 0.15%; 0.075%; 0.0375% QID for 14 days

4

Nystatin suspension

Group Type: ACTIVE_COMPARATOR

PAC113

Intervention Type: DRUG

PAC113 mouthrinse 0.15%; 0.075%; 0.0375% QID for 14 days

Interventions

PAC113

PAC113 mouthrinse 0.15%; 0.075%; 0.0375% QID for 14 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Are male or female 18 to 65 years of age, inclusive
• Are able and willing to follow study procedures and instructions
• Are able to read, understand and sign an informed consent form
• Are documented as HIV positive
• Have pseudomembranous and/or erythematous oral candidiasis as confirmed by potassium hydroxide preparation of mucosal scraping
• Have a CD4 cell count performed prior to randomization or within 6 weeks prior to the screening visit
• Have a viral load performed prior to randomization or within 6 weeks prior to the screening visit.
• Both men and women who are active heterosexually must be willing to practice a medically accepted method of birth control.

Exclusion Criteria

• Have received systemic antifungal therapy within 14 days of starting study
• Have received prior topical therapy for oral candidiasis within 7 days of starting study
• Have a concomitant fungal infection requiring systemic therapy
• Are currently receiving immunosuppressive therapy (e.g. corticosteroids), or cancer chemotherapy
• Female subjects who are pregnant (as determined by a positive serum or urine pregnancy test) or lactating, or female subjects who are of childbearing potential and who are not using hormonal or barrier methods of birth control (e.g., oral or parenteral contraceptives, diaphragm plus spermicide, condoms) or who have not characterized themselves as abstinent. Subjects who use hormonal contraceptives must have started the method at least 30 days prior to the screening examination
• Active substance abuse
• Have esophageal symptoms (dysphagia or odynophagia) unless esophageal candidiasis has been ruled out by endoscopy
• Have a life expectancy < 4 weeks
• Are currently receiving or have received an investigational agent in the last 30 days
• Have had a change in antiretroviral therapy within 14 days prior to study entry (this does not apply to dose adjustment of the same therapy)
• Have any of the following laboratory abnormalities:

• White blood cell (WBC) count <1,500 cells/mm3
• Neutrophil granulocyte count <1,000 cells/mm3
• Hemoglobin <9.0/dL
• Transaminases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) or bilirubin >3 times the upper limit of normal (ULN)
• Serum creatinine >2 times ULN
• Have peri-oral lesion (perleche) only
• Have oral manifestations of herpes simplex (active disease only), hairy leukoplakia and/or aphthous ulcers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

Pacgen Biopharmaceuticals Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Director, Drug Development

Locations

Rosedale Infectious Disease

Huntersville, North Carolina, United States

Countries

United States

Other Identifiers

PBC002-01

Identifier Type: -

Identifier Source: org_study_id