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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00002446 |
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Date of registration:
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02/11/1999 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients
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Scientific title:
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Randomized, Controlled Trial of SCH 56592 Oral Suspension Versus Fluconazole Suspension in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients |
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Date of first enrolment:
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August 1998 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00002446 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Barbados
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria
You may be eligible for this study if you:
- Are at least 18 years old.
- Are HIV-positive.
- Have thrush (oropharyngeal candidiasis).
- Agree to practice sexual abstinence or use effective barrier methods of birth control
(e.g., condoms).
- Are able to take study medication and return for clinic visits during the study.
- Are expected to live for at least 2 months.
Exclusion Criteria
You will not be eligible for this study if you:
- Have received protease inhibitors for the first time within 30 days prior to study
entry.
- Have received certain medications.
- Have certain other types of fungal infections.
- Have certain types of cancer.
- Have received SCH 56592 within 3 months prior to study entry.
- Are pregnant or breast-feeding.
- Cannot take medications by mouth.
- Are allergic to azole drugs.
- Have certain medical conditions.
- Have been in this study before.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Candidiasis, Oral
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Intervention(s)
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Drug: Fluconazole
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Drug: Posaconazole
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Secondary ID(s)
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I97-331
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C97-331
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305A
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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