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| Descriptive Information Fields | |
| Brief Title † | 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 † | 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 | |
| Study Phase | |
| Study Type † | Interventional |
| Study Design † | Treatment |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Candidiasis, Oral HIV Infections |
| Intervention † | Drug: Clotrimazole Drug: Fluconazole |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | 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).
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| Gender | Both |
| Ages | 13 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00002282 |
| Organization ID | 012M |
| Secondary IDs †† | 056-171 |
| Study Sponsor † | Pfizer |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | February 1990 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | June 23, 2005 |