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The objectives of this study are to compare the efficacy and safety of Roxane's clotrimazole troches vs. Mycelex troches in HIV positive patients with oropharyngeal candidiasis, where this condition has been diagnosed by clinical examination and confirmed by fungal culture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roxanes's clotrimazole troches | Experimental |
| |
| Mycelex® troches | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roxanes's clotrimazole troches | Drug |
| ||
| Mycelex® troches |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients that have a clinical response assessed by symptoms and physical examination | Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of negative fungal cultures of the oropharynx for Candida species | 7 days after end of treatment | |
| Incidence of negative fungal cultures of the oropharynx for Candida species | after 14 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002180 | Candidiasis, Oral |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Drug |
|
| Clinical response by symptom assessment and physical examination | after 7 and 14 days of treatment |
| Assessment of compliance with Treatment by troche Count and Patient interview | after 7 and 14 days of treatment |
| D009059 |
| Mouth Diseases |
| D009057 | Stomatognathic Diseases |