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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: | Treatment, Double-Blind, Safety Study |
| 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
| Study ID Numbers: | 288A, C96-209, I96-209 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002399 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Fluconazole Antifungal Agents Candidiasis Triazoles |
|
Mouth Diseases Trypanocidal Agents Communicable Diseases Anti-Infective Agents Antiprotozoal Agents Sexually Transmitted Diseases, Viral Candidiasis, Oral Slow Virus Diseases Candidiasis Infection Mycoses Antiparasitic Agents Antifungal Agents Therapeutic Uses |
Antibiotics, Antifungal Posaconazole Retroviridae Infections Fluconazole RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Stomatognathic Diseases |