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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00012467
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 3, 2009
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Meningitis, Cryptococcal HIV Infections Drug: Itraconazole Drug: Flucytosine Drug: Fluconazole Drug: Amphotericin B Drug: Interferon gamma-1b Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : January 2000
Actual Study Completion Date : July 2001

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00012467

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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
Univ of Texas / Med School at Houston
Houston, Texas, United States, 77030
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States, 78284
Hosp Nacional dos de Mayo
Lima, Peru
Instituto de Medicina Tropical
Lima, Peru
Sponsors and Collaborators
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Responsible Party: Steven Porter, MD, PhD, InterMune Pharmaceuticals Inc. Identifier: NCT00012467    
Other Study ID Numbers: B013
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 3, 2009
Last Verified: May 2009
Keywords provided by InterMune:
Interferon-gamma, Recombinant
Injections, Subcutaneous
Dose-Response Relationship, Drug
Antifungal Agents
Amphotericin B
Meningitis, Cryptococcal
Additional relevant MeSH terms:
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Meningococcal Infections
Meningitis, Cryptococcal
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Meningitis, Fungal
Central Nervous System Fungal Infections
Central Nervous System Infections
Amphotericin B
Liposomal amphotericin B
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antifungal Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists