Phase 2B Dose-Ranging Study of PAC113 Mouthrinse in HIV Seropositive Individuals With Oral Candidiasis
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ClinicalTrials.gov Identifier: NCT00659971 |
Recruitment Status :
Completed
First Posted : April 17, 2008
Last Update Posted : June 26, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Oral Candidiasis | Drug: PAC113 | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 223 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | January 2008 |
Actual Primary Completion Date : | June 2008 |
Actual Study Completion Date : | June 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
PAC113 0,15% mouthrinse
|
Drug: PAC113
PAC113 mouthrinse 0.15%; 0.075%; 0.0375% QID for 14 days |
Experimental: 2
PAC113 0,075% mouthrinse
|
Drug: PAC113
PAC113 mouthrinse 0.15%; 0.075%; 0.0375% QID for 14 days |
Experimental: 3
PAC113 0,0375% mouthrinse
|
Drug: PAC113
PAC113 mouthrinse 0.15%; 0.075%; 0.0375% QID for 14 days |
Active Comparator: 4
Nystatin suspension
|
Drug: PAC113
PAC113 mouthrinse 0.15%; 0.075%; 0.0375% QID for 14 days |
- Eliminating or reducing clinical signs and symptoms of oral Candida infections. [ Time Frame: Day 19 ]
- To evaluate the microbiological response of Candida to different concentrations of PAC-113. [ Time Frame: Day 19 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659971
United States, North Carolina | |
Rosedale Infectious Disease | |
Huntersville, North Carolina, United States, 28078 |
Responsible Party: | Pacgen Biopharmaceuticals Corp., Director, Drug Development |
ClinicalTrials.gov Identifier: | NCT00659971 |
Other Study ID Numbers: |
PBC002-01 |
First Posted: | April 17, 2008 Key Record Dates |
Last Update Posted: | June 26, 2008 |
Last Verified: | June 2008 |
oral candidiasis |
Candidiasis Candidiasis, Oral HIV Seropositivity Mycoses HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Mouth Diseases Stomatognathic Diseases |