Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients
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To determine the appropriate duration of amphotericin B therapy for Candida esophagitis. To compare the effectiveness of two different amphotericin B doses in the treatment of biopsy-proven Candida esophagitis. To determine if low-dose amphotericin B is less toxic than standard dose therapy during a limited treatment period. To evaluate pharmacokinetic and pharmacodynamic parameters of the two different dosing regimens.
Condition | Intervention |
---|---|
Candidiasis, Esophageal HIV Infections |
Drug: Amphotericin B |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients |
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Exclusion Criteria
Co-existing Condition:
Patients with histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis are excluded.
Concurrent Medication:
Excluded:
- Systemic administration of amphotericin B for a proven or suspected systemic fungal infection.
Patients with the following are excluded:
- Documented Candida fungemia.
- Histological or clinical (skin rash, cotton wool exudates, Candida endophthalmitis, etc.) evidence of disseminated candidiasis.
- Systemic administration of amphotericin B for a proven or suspected systemic fungal infection.
- Patient refusal to enter study.
Patient must be an immunosuppressed host, with biopsy-proven Candida esophagitis.
- Patients with polymicrobial esophagitis will be included as long as Candida esophagitis is documented by esophageal biopsy.
- Informed consent must be signed and obtained.
Additional Information:
No publications provided
ClinicalTrials.gov Identifier: | NCT00002041 History of Changes |
Other Study ID Numbers: | 001A, 875-10 |
Study First Received: | November 2, 1999 |
Last Updated: | October 1, 2007 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
AIDS-Related Opportunistic Infections Esophagitis Acquired Immunodeficiency Syndrome Amphotericin B Candidiasis, Oral |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Candidiasis Esophageal Diseases Esophagitis 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 Gastrointestinal Diseases Digestive System Diseases Gastroenteritis Amphotericin B Liposomal amphotericin B Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on March 07, 2013