Oral CandidiasisPhase 2NCT00659971
Phase 2B Dose-Ranging Study of PAC113 Mouthrinse in HIV Seropositive Individuals With Oral Candidiasis
A Phase 2 study testing PAC113 in people with Oral Candidiasis, run by Pacgen Biopharmaceuticals Corporation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Oral Candidiasis
- What is being tested?
- PAC113
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rosedale Infectious Disease
Huntersville, North Carolina, 28078
About this study
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
The purpose of this study is to determine the optimal dose of PAC113 mouthrinse for treatment of oral candidiasis in HIV seropositive patients.
Read the 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:
- 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.
- Conditions
- Oral Candidiasis
- Being tested
- PAC113
- Keywords
- oral candidiasis
- Medical subject headings
- Candidiasis, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAC113Drug
PAC113 mouthrinse 0.15%; 0.075%; 0.0375% QID for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PAC113 0,15% mouthrinse Receives: Drug: PAC113 |
| 2 | Experimental | PAC113 0,075% mouthrinse Receives: Drug: PAC113 |
| 3 | Experimental | PAC113 0,0375% mouthrinse Receives: Drug: PAC113 |
| 4 | Active comparator | Nystatin suspension Receives: Drug: PAC113 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eliminating or reducing clinical signs and symptoms of oral Candida infections.
Measured: Day 19
Secondary outcomes (1)
To evaluate the microbiological response of Candida to different concentrations of PAC-113.
Measured: Day 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacgen Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659971
- Sponsor's protocol ID
- PBC002-01
- Status last verified
- Jun 2008
- First submitted
- 18 Mar 2008
- Last updated
- 26 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00659971
- Acronym / sponsor ID
- PBC002-01
- Conditions
- Oral Candidiasis
- Keywords
- oral candidiasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Pacgen Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 17 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PAC113PAC113 0,15% mouthrinse |
| 2 | Experimental | Drug: PAC113PAC113 0,075% mouthrinse |
| 3 | Experimental | Drug: PAC113PAC113 0,0375% mouthrinse |
| 4 | Active comparator | Drug: PAC113Nystatin suspension |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAC113PAC113 mouthrinse 0.15%; 0.075%; 0.0375% QID for 14 days | Drug | 1, 2, 3, 4 |
Primary outcome
Eliminating or reducing clinical signs and symptoms of oral Candida infections.
Time frame: Day 19
1 secondary outcome
To evaluate the microbiological response of Candida to different concentrations of PAC-113.
Time frame: Day 19
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2008.
Related trials for Oral Candidiasis
RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Candidemia, Candidiasis, Invasive
RecruitingObservational study
Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
Vulvovaginitis, Candidal, Vulvovaginal Candidiasis
Not yet recruiting
Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model
Oral Lichen Planus, Recurrent Aphthous Stomatitis
RecruitingObservational study
Oropharyngeal Candidiasis (OPC) and S-ECC
Candida Infection, Oral Thrush
RecruitingPhase 4
Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants
Posaconazole, Pharmacokinetics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PAC113 in people with Oral Candidiasis, run by Pacgen Biopharmaceuticals Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eliminating or reducing clinical signs and symptoms of oral Candida infections. (time frame: Day 19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2008.