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

NCT00659971 | Completed Phase 2 DMC

• 1 other identifier: PBC002-01
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Candidiasis

Keywords

oral candidiasis

Outcome Measures

Primary Outcomes (1)

• Eliminating or reducing clinical signs and symptoms of oral Candida infections.

  Day 19

Secondary Outcomes (1)

• To evaluate the microbiological response of Candida to different concentrations of PAC-113.

  Day 19

Study Arms (4)

1

EXPERIMENTAL

PAC113 0,15% mouthrinse

Drug: PAC113

2

EXPERIMENTAL

PAC113 0,075% mouthrinse

Drug: PAC113

3

EXPERIMENTAL

PAC113 0,0375% mouthrinse

Drug: PAC113

4

ACTIVE COMPARATOR

Nystatin suspension

Drug: PAC113

Interventions

PAC113 DRUG

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

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pacgen Biopharmaceuticals Corporation: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

Rosedale Infectious Disease

Huntersville, North Carolina, 28078, United States

Location

MeSH Terms

Conditions

Candidiasis, Oral

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: April 17, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 26, 2008

Record last verified: 2008-06

Locations

US (1)