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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002277 |
Purpose
To compare the safety, tolerance and efficacy of fluconazole and amphotericin B as treatment for biopsy proven fungal infections in major organs, disseminated infection, suspected fungal infection and fungemia in adult neutropenic and non-neutropenic patients without AIDS, AIDS related complex (ARC), or extensive burns. HIV seropositive patients are allowed only if they also have a malignancy.
| Condition | Intervention | Phase |
|---|---|---|
|
Mycoses HIV Infections |
Drug: Fluconazole Drug: Amphotericin B |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Fluconazole Versus Amphotericin B: A Prospective, Randomized, Multicenter Study for Therapy of Fungal Infection |
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Contacts and Locations| United States, Texas | |
| M D Anderson Cancer Ctr | |
| Houston, Texas, United States, 77030 | |
| Dr Layne Gentry | |
| Houston, Texas, United States, 77030 | |
| Dr Temple Williams | |
| Houston, Texas, United States, 77030 | |
More Information
| Study ID Numbers: | 012N, 056-173 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002277 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Mycoses Neoplasms Neutropenia Fluconazole Amphotericin B |
|
Abelcet Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Antiprotozoal Agents Slow Virus Diseases Infection Liposomal amphotericin B Anti-Bacterial Agents Mycoses Antiparasitic Agents Therapeutic Uses Antifungal Agents Antibiotics, Antifungal |
Amebicides Retroviridae Infections Fluconazole Amphotericin B RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |