Safety and Antifungal Activity of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Cryptococcal Meningitis

May 29, 2009 updated by: InterMune

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

The purpose of this study is to examine the antifungal activity of recombinant interferon-gamma 1b (rIFN-gamma 1b) given with standard antifungal therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
      • Lima, Peru
        • Hosp Nacional dos de Mayo
      • Lima, Peru
        • Instituto de Medicina Tropical
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ of Alabama at Birmingham
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Washington Univ
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • UMDNJ - New Jersey Med School / Cooper Hosp
      • Newark, New Jersey, United States, 07103
        • Univ of Med & Dentistry of New Jersey
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Veterans Administration Med Ctr
      • Houston, Texas, United States, 77030
        • Univ of Texas / Med School at Houston
      • San Antonio, Texas, United States, 78284
        • Audie L Murphy Veterans Administration Hosp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InterMune

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Study Completion (Actual)

July 1, 2001

Study Registration Dates

First Submitted

March 9, 2001

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 3, 2009

Last Update Submitted That Met QC Criteria

May 29, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B013
  • GIMY-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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