Candidiasis, OralNCT00002282
A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients With AIDS
A study testing Clotrimazole and Fluconazole in people with Candidiasis, Oral and HIV Infections, run by Pfizer at 17 sites in United States.
Trial summary
To compare the efficacy, safety, and tolerance of fluconazole single daily capsule for 14 days versus clotrimazole troche 5 x daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS. 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?
- Clotrimazole and Fluconazole
- How many people
- Not given
- Where
- 17 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:
- Cimetidine.
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- Known history of intolerance or allergy to imidazoles or triazoles, or the non-azole components of clotrimazole troches (dextrose, cellulose, povidone, magnesium stearate).
- Moderate or severe liver disease defined by specified lab values.
- Concurrent Medication:
- Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:
Show all 31Show fewer
- Barbiturates.
- Phenytoin.
- Coumarin-type anticoagulants.
- Rifampin.
- Oral hypoglycemics.
- Cyclosporin.
- Patients with the following are excluded:
- Known history of intolerance or allergy to imidazoles or triazoles, or the non-azole components of clotrimazole troches (dextrose, cellulose, povidone, magnesium stearate).
- Unable to tolerate oral medication.
- Moderate or severe liver disease defined by specified lab values.
- Life expectancy < 4 weeks.
- Unable or unwilling to be followed at the same center for the conduct of this study.
- Prior Medication:
- Excluded within 3 days of study entry:
- Other antifungal agents.
- Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:
- Barbiturates.
- Phenytoin.
- Coumarin-type anticoagulants.
- Rifampin.
- Oral hypoglycemics.
- Cyclosporin.
- Patients meeting CDC criteria for diagnosis of AIDS, or having serologic or virologic evidence of HIV infection (but without AIDS-defining opportunistic infections as of yet).
- Patients who have given informed consent in writing to their participation in the study.
- Patients with signs of oropharyngeal candidiasis, i.e., with typical white plaques.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
Johns Hopkins Hosp
Baltimore, Maryland, 21205
Univ Hosp
Boston, Massachusetts, 02118
Ohio State Univ Hosp
Columbus, Ohio, 43210
Dr Robert Larsen
Los Angeles, California, 90033
Saint Raphael's Hosp
New Haven, Connecticut, 06511
Cabrini Med Ctr
New York, New York, 10003
Cornell Univ Med Ctr
New York, New York, 10021
Saint Michael's Med Ctr
Newark, New Jersey, 07102
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284
Davies Med Ctr
San Francisco, California, 94114
UCSF Hosp
San Francisco, California, 941430654
Washington Univ School of Medicine
St Louis, Missouri, 63108
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
About this study
Official title: A Randomized Multicenter Study of the Efficacy, Safety, and Toleration of Fluconazole or Clotrimazole Troches in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
To compare the efficacy, safety, and tolerance of fluconazole single daily capsule for 14 days versus clotrimazole troche 5 x daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS.
- Conditions
- Candidiasis, Oral, HIV Infections
- Being tested
- Clotrimazole, Fluconazole
- Keywords
- AIDS-Related Opportunistic Infections, Fluconazole, Clotrimazole, Acquired Immunodeficiency Syndrome, Candidiasis, Oral
- Medical subject headings
- Candidiasis, Oral, HIV Infections, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClotrimazoleDrug
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
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002282
- Sponsor's protocol ID
- 012M
- Other IDs
- 056-171
- Status last verified
- Feb 1990
- 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
- A Randomized Multicenter Study of the Efficacy, Safety, and Toleration of Fluconazole or Clotrimazole Troches in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
- ClinicalTrials.gov ID
- NCT00002282
- Acronym / sponsor ID
- 012M
- Conditions
- Candidiasis, Oral, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Fluconazole, Clotrimazole, Acquired Immunodeficiency Syndrome, 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 tolerance of fluconazole single daily capsule for 14 days versus clotrimazole troche 5 x daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Cimetidine.
Key exclusion criteria (31 listed)
- Known history of intolerance or allergy to imidazoles or triazoles, or the non-azole components of clotrimazole troches (dextrose, cellulose, povidone, magnesium stearate).
- Moderate or severe liver disease defined by specified lab values.
- Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:
- Barbiturates.
- Phenytoin.
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 |
|---|---|---|
| Clotrimazole | 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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clotrimazole and Fluconazole in people with Candidiasis, Oral and HIV Infections, run by Pfizer at 17 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 3 inclusion and 31 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 17 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.