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Safety and Antifungal Activity of Recombinant Interferon-gamma 1b (rIFN-gamma 1b) Given with Standard Therapy in Patients with Cryptococcal Meningitis Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Safety and Antifungal Activity of Recombinant Interferon-gamma 1b (rIFN-gamma 1b) Given with Standard Therapy in Patients with Cryptococcal Meningitis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety and Antifungal Activity of Recombinant Interferon-gamma 1b (rIFN-gamma 1b) Given with Standard Therapy in Patients with Cryptococcal Meningitis Clinical research trials and Safety and Antifungal Activity of Recombinant Interferon-gamma 1b (rIFN-gamma 1b) Given with Standard Therapy in Patients with Cryptococcal Meningitis healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Safety and Antifungal Activity of Recombinant Interferon-gamma 1b (rIFN-gamma 1b) Given with Standard Therapy in Patients with Cryptococcal Meningitis. Safety and Antifungal Activity of Recombinant Interferon-gamma 1b (rIFN-gamma 1b) Given with Standard Therapy in Patients with Cryptococcal Meningitis Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Safety and Antifungal Activity of Recombinant Interferon-gamma 1b (rIFN-gamma 1b) Given with Standard Therapy in Patients with Cryptococcal Meningitis clinical trial. Subjects frequently obtain the most expert healthcare possible for their Safety and Antifungal Activity of Recombinant Interferon-gamma 1b (rIFN-gamma 1b) Given with Standard Therapy in Patients with Cryptococcal Meningitis condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and Antifungal Activity of Recombinant Interferon-gamma 1b (rIFN-gamma 1b) Given with Standard Therapy in Patients with Cryptococcal Meningitis  Safety and Antifungal Activity of Recombinant Interferon-gamma 1b (rIFN-gamma 1b) Given with Standard Therapy in Patients with Cryptococcal Meningitis
Safety and Antifungal Activity of Recombinant Interferon-gamma 1b (rIFN-gamma 1b) Given with Standard Therapy in Patients with Cryptococcal Meningitis
For Condition: Meningitis, Cryptococcal,HIV Infections
Status: No longer recruiting
Sponsor(s): InterMune ,
Synopsis: The purpose of this study is to examine the antifungal activity of recombinant interferon-gamma 1b (rIFN-gamma 1b) given with standard antifungal therapy.
Details: 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:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for Stage 1 if they: - Are at least 13 years old. - Have consent of a parent, family member, or guardian if less than 18 years of age. - Have cryptococcal meningitis for the first time or have had a relapse. - Are not on any medications that cannot be taken with fluconazole or itraconazole, if the patient has trouble taking fluconazole. - Patients may be eligible for Stage 2 if they: - Had no serious decline in health, as determined by their doctor, during the previous 14 days (including mental health). - Have received at least 7.5 mg/kg AMB in Stage 1. - Have a positive CSF culture for C. neoformans. - Can take oral medications. Exclusion Criteria Patients will not be eligible for this study if they: - Are in a coma. - Are pregnant or breast-feeding. - Are not using effective birth control methods, if able to have children. - Are allergic to imidazole or triazole. - Are allergic to rIFN-gamma 1b. - Require drugs that are toxic to the kidneys, other than AMB. - Received erythropoietin or red blood cell transfusions within 4 weeks of entering the study. - Are receiving systemic corticosteroid therapy within 30 days of study or will require it during the study. - Have had serious heart disease. - Have had multiple sclerosis, peripheral vascular disease, or rheumatologic disorders. - Have had disorders of the central nervous system (CNS) (not including emotional problems) or a seizure disorder, or have a current CNS disorder that would interfere with the study. - Are receiving investigational therapy for C. neoformans within 90 days of starting the study drug. - Have had more than 3 doses of AMB or more than 1200 mg of fluconazole or itraconazole as prior treatment and have begun current treatment for more than 72 hours prior to starting study medication. Fluconazole or itraconazole of no more than 200 mg daily is allowed. - Are receiving AMB for C. neoformans within 30 days of starting treatment for the present episode. - Are receiving rIFN-gamma 1b treatment within 90 days prior to starting the study drug. - Have had therapy which affects the immune system within 30 days prior to starting the study drug. - Are receiving investigational therapy for all other signs within 30 days prior to starting the study drug. - Are not able to meet the study requirements, in the opinion of the investigator. - Require chronic treatment with H2-blockers, and are able to receive only itraconazole in Stage 2. - Show signs of or get treatment for another serious opportunistic infection within 4 weeks of starting the study drug.
Total Enrollment: 60
Location and Contact Information:
Instituto de Medicina Tropical
Lima, ,
Peru
UMDNJ - New Jersey Med School / Cooper Hosp
Camden, New Jersey, 08103
United States
Washington Univ
St. Louis, Missouri, 63108
United States
Univ of Texas / Med School at Houston
Houston, Texas, 77030
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Hosp Nacional dos de Mayo
Lima, ,
Peru
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284
United States
Univ of Med & Dentistry of New Jersey
Newark, New Jersey, 07103
United States
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: B013; GIMY-001
Study Start Date:
Record last reviewed: June 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012467
Other Hiv Infections Studies:
1. Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
2. A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
3. SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy
4. A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success with Amphotericin B
5. Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
Related Studies:
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Safety and Antifungal Activity of Recombinant Interferon-gamma 1b (rIFN-gamma 1b) Given with Standard Therapy in Patients with Cryptococcal Meningitis
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