Last reviewed · How we verify
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
Phase 2 trial testing Itraconazole in Meningitis, Cryptococcal in 60 participants. Completed in 1 July 2001.
Quick facts
| Lead sponsor | InterMune |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 January 2000 |
| Estimated completion | 1 July 2001 |
| Sites | 9 locations across United States, Peru |
Drugs / interventions tested
- Itraconazole — full drug profile →
- Flucytosine (FLUCYTOSINE) — full drug profile →
- Fluconazole (fluconazole) — full drug profile →
- Amphotericin B (AMPHOTERICIN B) — full drug profile →
- Interferon gamma-1b
Conditions studied
- Meningitis, Cryptococcal — all drugs for Meningitis, Cryptococcal →
- HIV Infections — all drugs for HIV Infections →
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):
-
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 -
New Approaches for Cryptococcosis Treatment.
Spadari CC, Wirth F, Lopes LB, Ishida K. · · 2020 · cited 45× · PMID 32340403 · DOI 10.3390/microorganisms8040613 -
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 -
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
Verify or expand the search:
- PubMed search for NCT00012467
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Itraconazole
Trials testing the same drug.
- NCT07341672 — A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itrac · Phase 1 · not yet recruiting
- NCT06732388 — Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's E · Phase 2 · not yet recruiting
- NCT07449390 — Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole · Phase 1 · not yet recruiting
- NCT07435194 — A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazo · Phase 1 · recruiting
- NCT07308652 — A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 764198 in the Blood · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00012467 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by InterMune
- Last refreshed: 29 May 2009
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00012467.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing