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

Oral Candidiasis Clinical Trial

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 Dose of PAC113

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659971
• Other study ID #: PBC002-01
• Status: Completed
• Phase: Phase 2
• First received: March 18, 2008
• Last updated: June 25, 2008
• Start date: January 2008
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: Pacgen Biopharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral
• HIV Seropositivity
• Oral Candidiasis

Intervention

Drug:
• PAC113
PAC113 mouthrinse 0.15%; 0.075%; 0.0375% QID for 14 days

Locations

Country	Name	City	State
United States	Rosedale Infectious Disease	Huntersville	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Pacgen Biopharmaceuticals Corporation	Quintiles, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eliminating or reducing clinical signs and symptoms of oral Candida infections.		Day 19	No
Secondary	To evaluate the microbiological response of Candida to different concentrations of PAC-113.		Day 19	No