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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001065 |
Purpose
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 |
|---|---|---|
|
Candidiasis, Oral HIV Infections |
Drug: Amphotericin B |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Amphotericin B Oral Suspension for Fluconazole-Resistant Oral Candidiasis in HIV-Infected Patients |
| Estimated Enrollment: | 70 |
| Primary Completion Date: | April 1998 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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:
Contacts and Locations
Show 51 Study Locations| Study Chair: | Zingman BS | |
| Study Chair: | Wheat LJ |
More Information
| ClinicalTrials.gov Identifier: | NCT00001065 History of Changes |
| Other Study ID Numbers: | ACTG 295 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 1, 2011 |
| Health Authority: | United States: Federal Government |
|
Administration, Oral Acquired Immunodeficiency Syndrome Amphotericin B |
AIDS-Related Complex Candidiasis, Oral Suspensions |
|
HIV Infections Acquired Immunodeficiency Syndrome Candidiasis Candidiasis, Oral 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 Amphotericin B Liposomal amphotericin B Fluconazole Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Bacterial Agents 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |