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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00012467
• Date of registration: 09/03/2001
• Prospective Registration: No
• Primary sponsor: InterMune
• Public title: Safety and Antifungal Activity of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Cryptococcal Meningitis
• Scientific 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
• Date of first enrolment: January 2000
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00012467
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Peru, United States

Key inclusion & exclusion 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.



Age minimum: 13 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Meningitis, Cryptococcal

HIV Infections

Intervention(s)

Drug: Fluconazole

Drug: Amphotericin B

Drug: Itraconazole

Drug: Flucytosine

Drug: Interferon gamma-1b

Secondary ID(s)

GIMY-001

B013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors