Back to resultsPhase 2B Dose-Ranging Study of PAC113 Mouthrinse in HIV Seropositive Individuals With Oral Candidiasis
Primary Purpose
Oral Candidiasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PAC113
Sponsored by
About this trial
This is an interventional treatment trial for Oral Candidiasis focused on measuring oral candidiasis
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
Sites / Locations
- Rosedale Infectious Disease
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
4
Arm Description
PAC113 0,15% mouthrinse
PAC113 0,075% mouthrinse
PAC113 0,0375% mouthrinse
Nystatin suspension
Outcomes
Primary Outcome Measures
Eliminating or reducing clinical signs and symptoms of oral Candida infections.
Secondary Outcome Measures
To evaluate the microbiological response of Candida to different concentrations of PAC-113.
Full Information
NCT ID
NCT00659971
First Posted
March 18, 2008
Last Updated
June 25, 2008
Sponsor
Pacgen Biopharmaceuticals Corporation
Collaborators
Quintiles, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00659971
Brief Title
Phase 2B Dose-Ranging Study of PAC113 Mouthrinse in HIV Seropositive Individuals With Oral Candidiasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pacgen Biopharmaceuticals Corporation
Collaborators
Quintiles, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Candidiasis
Keywords
oral candidiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
223 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
PAC113 0,15% mouthrinse
Arm Title
2
Arm Type
Experimental
Arm Description
PAC113 0,075% mouthrinse
Arm Title
3
Arm Type
Experimental
Arm Description
PAC113 0,0375% mouthrinse
Arm Title
4
Arm Type
Active Comparator
Arm Description
Nystatin suspension
Intervention Type
Drug
Intervention Name(s)
PAC113
Intervention Description
PAC113 mouthrinse 0.15%; 0.075%; 0.0375% QID for 14 days
Primary Outcome Measure Information:
Title
Eliminating or reducing clinical signs and symptoms of oral Candida infections.
Time Frame
Day 19
Secondary Outcome Measure Information:
Title
To evaluate the microbiological response of Candida to different concentrations of PAC-113.
Time Frame
Day 19
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Rosedale Infectious Disease
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase 2B Dose-Ranging Study of PAC113 Mouthrinse in HIV Seropositive Individuals With Oral Candidiasis
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