Candidiasis, OralNCT00002112
Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
A study testing Nystatin and Fluconazole in people with Candidiasis, Oral and HIV Infections, run by Pfizer at 5 sites in United States.
Trial summary
To compare the efficacy, safety, and toleration of fluconazole as a single daily oral suspension for 14 days versus nystatin oral suspension 4 times daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS or HIV infection. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Candidiasis, Oral, HIV Infections
- What is being tested?
- Nystatin and Fluconazole
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Phenytoin.
- Oral hypoglycemics.
- Coumarin-type anticoagulants.
- Cyclosporine.
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- Patients must have:
- ARC or AIDS.
- Signs of oropharyngeal candidiasis (i.e., typical white plaques) with some associated symptoms.
- Confirmation of diagnosis by microscopic exam and culture of organism.
- Life expectancy of at least 4 weeks.
- NOTE:
- Patients with signs or symptoms of esophagitis (e.g., odynophagia) are not eligible unless esophagoscopy is performed and results are negative.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions are excluded:
- Unable to tolerate oral medication.
- Concurrent enrollment on another experimental trial of approved or non-approved drugs or systemic compounds (without approval of Pfizer clinical monitor).
- Concurrent Medication:
- Excluded:
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- Antifungal agents other than study drugs.
- Other experimental medications.
- Patients with the following prior conditions are excluded:
- Known history of intolerance or allergy to imidazoles or triazoles or the polyene components of nystatin.
- Prior Medication:
- Excluded:
- Other antifungal agents within the past 3 days.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
California Med Research Group
Fresno, California, 93726
Hampton Roads Med Specialists
Hampton, Virginia, 23666
Med College of Pennsylvania
Philadelphia, Pennsylvania, 19129
UCSF Hosp
San Francisco, California, 94143
About this study
To compare the efficacy, safety, and toleration of fluconazole as a single daily oral suspension for 14 days versus nystatin oral suspension 4 times daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS or HIV infection.
Read the detailed description
Patients are randomized to receive fluconazole oral suspension once daily (swallowed at approximately the same time every day) for 14 days or nystatin oral suspension used to rinse the mouth four times daily for 14 days. No food or drink is permitted immediately following the administration of the nystatin.
- Conditions
- Candidiasis, Oral, HIV Infections
- Being tested
- Nystatin, Fluconazole
- Keywords
- Nystatin, Fluconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis, Oral
- Medical subject headings
- Candidiasis, Oral, HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NystatinDrug
FluconazoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidiasis, OralStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002112
- Sponsor's protocol ID
- 012Q
- Other IDs
- R-0223
- Status last verified
- Apr 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
- ClinicalTrials.gov ID
- NCT00002112
- Acronym / sponsor ID
- 012Q
- Conditions
- Candidiasis, Oral, HIV Infections
- Keywords
- Nystatin, Fluconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis, Oral
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (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.
To compare the efficacy, safety, and toleration of fluconazole as a single daily oral suspension for 14 days versus nystatin oral suspension 4 times daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS or HIV infection.
Detailed description
Patients are randomized to receive fluconazole oral suspension once daily (swallowed at approximately the same time every day) for 14 days or nystatin oral suspension used to rinse the mouth four times daily for 14 days. No food or drink is permitted immediately following the administration of the nystatin.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Phenytoin.
- Oral hypoglycemics.
- Coumarin-type anticoagulants.
- Cyclosporine.
- ARC or AIDS.
Key exclusion criteria (13 listed)
- Unable to tolerate oral medication.
- Concurrent enrollment on another experimental trial of approved or non-approved drugs or systemic compounds (without approval of Pfizer clinical monitor).
- Antifungal agents other than study drugs.
- Other experimental medications.
- Known history of intolerance or allergy to imidazoles or triazoles or the polyene components of nystatin.
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 |
|---|---|---|
| Nystatin | Drug | – |
| Fluconazole | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nystatin and Fluconazole in people with Candidiasis, Oral and HIV Infections, run by Pfizer at 5 sites 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 13 inclusion and 13 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
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.
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 24 Jun 2005.