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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002399 |
Purpose
The purpose of this study is to compare the safety and effectiveness of SCH 56592 with that of fluconazole in the treatment of OPC (a fungal infection of the throat) in HIV-positive patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Candidiasis, Oral HIV Infections |
Drug: Posaconazole Drug: Fluconazole |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Phase II Study to Evaluate the Safety, Tolerance and Efficacy of Multiple Doses of SCH 56592 Versus Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with any of the following prior conditions are excluded:
Prior Medication:
Excluded (wash-outs for medications):
Current known drug abuse, in the opinion of the lead investigator, that would interfere with the subject's participation in the study.
Contacts and Locations
Show 53 Study Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00002399 History of Changes |
| Other Study ID Numbers: | 288A, C96-209, I96-209 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Fluconazole Antifungal Agents Candidiasis Triazoles |
|
HIV Infections Acquired Immunodeficiency Syndrome Candidiasis Candidiasis, Oral HIV Seropositivity Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Mycoses |
Mouth Diseases Stomatognathic Diseases Fluconazole Posaconazole Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Trypanocidal Agents Antiprotozoal Agents Antiparasitic Agents |