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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Bristol-Myers Squibb |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001065 |
To assess response and toxicity in patients with fluconazole-resistant oral candidiasis ( thrush ) when given initial induction with amphotericin B oral suspension.
Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging.
Condition | Intervention | Phase |
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Candidiasis, Oral HIV Infections |
Drug: Amphotericin B |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of Amphotericin B Oral Suspension for Fluconazole-Resistant Oral Candidiasis in HIV-Infected Patients |
Estimated Enrollment: | 70 |
Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging.
Patients swish and swallow amphotericin B oral suspension after each meal and at bedtime for 14 days, at which time they are deemed a responder, nonresponder, or failure to induction therapy. Responders receive maintenance twice daily, while nonresponders receive 14 further days of initial induction. Failures discontinue the study. Responders after 28 days of induction are placed on maintenance. After successful completion of initial induction, patients remain on study for 6 months.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded within 6 weeks prior to study entry:
Study Chair: | Zingman BS | |
Study Chair: | Wheat LJ |
Study ID Numbers: | ACTG 295 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00001065 |
Health Authority: | United States: Federal Government |
Administration, Oral Acquired Immunodeficiency Syndrome Amphotericin B |
AIDS-Related Complex Candidiasis, Oral Suspensions |
Fluconazole Abelcet Mouth Diseases Amphotericin B Candidiasis, Oral Sexually Transmitted Diseases, Viral Candidiasis Clotrimazole Miconazole Acquired Immunodeficiency Syndrome |
Tioconazole AIDS-Related Complex Liposomal amphotericin B Immunologic Deficiency Syndromes Virus Diseases Mycoses HIV Infections Sexually Transmitted Diseases Stomatognathic Diseases Retroviridae Infections |
Communicable Diseases Anti-Infective Agents RNA Virus Infections Antiprotozoal Agents Slow Virus Diseases Immune System Diseases Infection Pharmacologic Actions |
Anti-Bacterial Agents Antiparasitic Agents Therapeutic Uses Antifungal Agents Antibiotics, Antifungal Lentivirus Infections Amebicides |