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NCT00012467

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

Completed Phase 2 Last updated 29 May 2009
What this trial tests

Phase 2 trial testing Itraconazole in Meningitis, Cryptococcal in 60 participants. Completed in 1 July 2001.

Timeline
1 January 2000
1 July 2001

Quick facts

Lead sponsorInterMune
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Maskingdouble
Primary purposetreatment
Enrollment60
Start date1 January 2000
Estimated completion1 July 2001
Sites9 locations across United States, Peru

Drugs / interventions tested

Conditions studied

Sponsor

InterMune — full company profile →

Who can join

13 and older, any sex, with Meningitis, Cryptococcal or HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Clinical Use of Interferon-gamma.
    Miller CH, Maher SG, Young HA. · · 2009 · cited 244× · PMID 20074276 · DOI 10.1111/j.1749-6632.2009.05069.x
  2. New Approaches for Cryptococcosis Treatment.
    Spadari CC, Wirth F, Lopes LB, Ishida K. · · 2020 · cited 45× · PMID 32340403 · DOI 10.3390/microorganisms8040613
  3. Cryptococcosis and Cryptococcal Meningitis: A Narrative Review and the Up-to-Date Management Approach.
    Qureshi ZA, Ghazanfar H, Altaf F, Ghazanfar A, et al · · 2024 · cited 5× · PMID 38571832 · DOI 10.7759/cureus.55498
  4. Next-generation antifungal drugs: Mechanisms, efficacy, and clinical prospects.
    Lu X, Zhou J, Ming Y, Wang Y, et al · · 2025 · cited 2× · PMID 40893690 · DOI 10.1016/j.apsb.2025.06.013

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