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| Sponsor: | InterMune |
|---|---|
| Information provided by: | InterMune |
| ClinicalTrials.gov Identifier: | NCT00012467 |
Purpose
The purpose of this study is to examine the antifungal activity of recombinant interferon-gamma 1b (rIFN-gamma 1b) given with standard antifungal therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningitis, Cryptococcal HIV Infections |
Drug: Itraconazole Drug: Flucytosine Drug: Fluconazole Drug: Amphotericin B Drug: Interferon gamma-1b |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Phase II Study of the Safety and Antifungal Activity of Subcutaneous Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) in Conjunction With Standard Therapy in Patients With Acute Cryptococcal Meningitis |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2000 |
| Study Completion Date: | July 2001 |
Patients are randomized into 1 of 3 parallel groups for a 3-arm, 2-stage, double-blind and dose-ranging study for 14 weeks. In Stage 1, patients are hospitalized for 14 days of acute therapy. Patients receive rIFN-gamma 1b or placebo sc 3 times per week, intravenous (IV) AMB daily, and with or without oral 5-FC every 6 hours. Patients who have the ability to take oral medications, who do not have any significant clinical deterioration during the previous 14 days, and who meet the eligibility criteria can progress to Stage 2. In Stage 2 patients receive 84 days of consolidation therapy (56 days with study drug and 28 days of follow-up). On an outpatient basis, patients receive either placebo or 1 of 2 doses of rIFN-gamma 1b sc 3 times per week, and oral fluconazole daily or oral itraconazole 2 times a day.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for Stage 1 if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Missouri | |
| Washington Univ | |
| St Louis, Missouri, United States, 63108 | |
| United States, New Jersey | |
| UMDNJ - New Jersey Med School / Cooper Hosp | |
| Camden, New Jersey, United States, 08103 | |
| Univ of Med & Dentistry of New Jersey | |
| Newark, New Jersey, United States, 07103 | |
| United States, Texas | |
| Houston Veterans Administration Med Ctr | |
| Houston, Texas, United States, 77030 | |
| Audie L Murphy Veterans Administration Hosp | |
| San Antonio, Texas, United States, 78284 | |
| Univ of Texas / Med School at Houston | |
| Houston, Texas, United States, 77030 | |
| Peru | |
| Instituto de Medicina Tropical | |
| Lima, Peru | |
| Hosp Nacional dos de Mayo | |
| Lima, Peru | |
More Information
| Responsible Party: | InterMune Pharmaceuticals Inc. ( Steven Porter, MD, PhD ) |
| Study ID Numbers: | B013, GIMY-001 |
| Study First Received: | March 9, 2001 |
| Last Updated: | May 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00012467 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Interferon-gamma, Recombinant Injections, Subcutaneous Itraconazole Dose-Response Relationship, Drug Fluconazole |
Flucytosine Antifungal Agents Amphotericin B Meningitis, Cryptococcal |
|
Antimetabolites Abelcet Anti-Infective Agents Antiprotozoal Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Interferon Type II Antineoplastic Agents Flucytosine Hydroxyitraconazole Itraconazole Infection Liposomal amphotericin B Meningitis |
Anti-Bacterial Agents Mycoses Antiparasitic Agents Therapeutic Uses Antifungal Agents Antibiotics, Antifungal Meningitis, Cryptococcal Amebicides Central Nervous System Fungal Infections Retroviridae Infections Fluconazole Amphotericin B RNA Virus Infections Meningitis, Fungal Immune System Diseases |