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
NCT00002282
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Adult Trials: 18+ Years
Concurrent Medication:
Allowed:
- Cimetidine.
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:
- 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.
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| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | 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 | ||
| Official Title ICMJE | 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 | ||
| Brief 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. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Not Applicable | ||
| Study Design ICMJE | Primary Purpose: Treatment | ||
| Condition ICMJE |
| ||
| Intervention ICMJE |
| ||
| Study Arms ICMJE | Not Provided | ||
| Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE | Not Provided | ||
| Original Enrollment ICMJE | Not Provided | ||
| Study Completion Date ICMJE | Not Provided | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Allowed:
Exclusion Criteria Co-existing Condition: Patients with the following are excluded:
Concurrent Medication: Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:
Patients with the following are excluded:
Prior Medication: Excluded within 3 days of study entry:
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).
| ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 13 Years and older (Child, Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00002282 | ||
| Other Study ID Numbers ICMJE | 012M 056-171 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Not Provided | ||
| Study Sponsor ICMJE | Pfizer | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | NIH AIDS Clinical Trials Information Service | ||
| Verification Date | February 1990 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||