Status:
COMPLETED
Phase 2B Dose-Ranging Study of PAC113 Mouthrinse in HIV Seropositive Individuals With Oral Candidiasis
Lead Sponsor:
Pacgen Biopharmaceuticals Corporation
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Oral Candidiasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 recruite...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT00659971
Start Date
January 1 2008
End Date
June 1 2008
Last Update
June 26 2008
Active Locations (1)
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1
Rosedale Infectious Disease
Huntersville, North Carolina, United States, 28078