NIAID MYCOSES STUDY GROUP STUDIES

(NIAID MSG and BAMSG Clinical Research Studies)
  • Study #1  –  Comparison of Two Different Regimens of Fluorocytosine and Amphotericin B in the Therapy of Cryptococcal Meningitis.
  • Study #2  – Phase II Studies on Ketoconazole.
  • Study #3A – Phase III Studies on Ketoconazole – Comparison of the Efficacy and Toxicity of Two Different Dosage Regimens of Oral Ketoconazole in Randomly Assigned Patients with Either Blastomycosis or Histoplasmosis.
  • Study #3B –  Phase III Studies on Ketoconazole – Comparison of the Efficacy and Toxicity of Two Different Dosage Regimens of Oral Ketoconazole in Randomly Assigned Patients with Coccidioidomycosis Including a Provision for Ascending Doses of Ketoconazole.
  • Study #3C –  Phase III Studies on Ketoconazole – Pharmacokinetics and Toxicity of Various Doses of Ketoconazole in Persons with Coccidioidal Meningitis.
  • Study #4A –  Phase II and III Studies of Itraconazole – Pharmacokinetic, Toxicologic, and Uncontrolled Evaluation of Efficacy of Itraconazole Administered in Different Doses to Patients with Progressive Forms of Coccidioidomycosis.
  • Study #4C –  Comparison of Efficacy and Toxicity of Short Course Intrathecal Amphotericin B Followed by High Dose Ketoconazole with Traditional Amphotericin B for Coccidioidal Meningitis.  (Closed due to poor enrollment)
  • Study #6A –  Phase I and II Evaluation of Itraconazole – Pharmacokinetics, Toxicity, and Clinical Response Data in Patients with Non-Meningeal Non-Life-Threatening Blastomycosis, Histoplasmosis, and Sporotrichosis.
  • Study #6C –  Phase II Studies on Ketoconazole – Prospective Comparison of the Efficacy and Toxicity of Amphotericin B versus Ketoconazole Therapy in Randomly Assigned Seriously Ill Patients with Non-Meningeal Blastomycosis or Histoplasmosis, After an Induction Course of Therapy with Amphotericin B.
  • Study #7  –   An OpenNon-ComparativeMulticenter Study of the Efficacy, Safety and Toleration of Fluconazole Given Orally in the Treatment of Non-Life Threatening Systemic Fungal Infection.
  • Study #8A –  Multicenter Comparison of Fluconazole and Amphotericin B as Treatment of Acute Cryptococcal Meningitis.  (Pfizer Protocol 159).
  • Study #8B –  Multi-Center Comparison of Fluconazole and Amphotericin B as a Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients with Acquired Immunodeficiency Syndrome.  (Pfizer Protocol 157/158).
  • Study #8C –  Multicenter Evaluation of Fluconazole as Treatment for Acute Cryptococcal Meningitis in Patients Who Have Failed to Respond or Have Experienced Unacceptable Toxicity During Treatment with Amphotericin B.  (Pfizer Protocol 161).
  • Study #9  –  Open, Non-Comparative Study of Fluconazole in Patients with Non-Meningeal Progressive Coccidioidomycosis.
  • Study #10 –  Amphotericin B Treatment of Candidemia.  (Closed due to poor enrollment)
  • Study #11 –  Open, Non-Comparative Study of Fluconazole Therapy in Patients with Coccidioidal Meningitis (Pfizer)
  • Study #12 –  Phase II SCH 39304 Dose Finding Study Treatment of Progressive Forms of Coccidioidomycosis (Schering)
  • Study #13 –  Open, ComparativeMulti-Center Study of Two Doses of Fluconazole in Patients with Non-Acute Histoplasmosis, and Blastomycosis and with Sporotrichosis
  • Study #14 –  Pilot Study to Determine the Feasibility of Itraconazole for Suppression of Relapse of Disseminated Histoplasmosis in Patients with the Acquired Immunodeficiency Syndrome (ACTG 084/Janssen)
  • Study #15 –  Open Non-Comparative Study of the Efficacy of Itraconazole in Aspergillus sp. Infections (NIAID)
  • Study #16 –  SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy. (Schering) (Study terminated due to drug toxicity in lab animals)
  • Study #17 –  A Randomized Double Blind Protocol Comparing Amphotericin B with Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis (ACTG 159/Janssen)
  • Study #18 –  A Prospective Multicenter Randomized Comparison of Fluconazole and Placebo in the Treatment of Funguria (Pfizer)
  • Study #18A- Duke Funguria Surveillance Project (Duke)
  • Study #19 –  Efficacy and Safety of Amphotericin B Lipid Complex Compared to Amphotericin B in the Treatment of Invasive Candidiasis. (Cancelled due to lack of drug company support)
  • Study #20 –  Fluconazole vs Itraconazole Therapy for Non-Meningeal Coccidioidomycosis (NIAID)
  • Study #21 –  Multicenter, Randomized Study of Oral Itraconazole vs Amphotericin B for the Treatment of Invasive Aspergillosis (NIAID) (Closed due to poor enrollment)
  • Study #22 –  Itraconazole vs Placebo as an Adjunctive Treatment of Corticosteroid-Dependent Allergic Bronchopulmonary Aspergillosis:  A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial (NIAID)
  • Study #23 –  Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients with AIDS (ACTG 074/Pfizer)
  • Study #24 –  Antifungal Prophylaxis of Coccidioidomycosis During HIV Infection (Pfizer) (Closed due to poor enrollment)
  • Study #25 –  Double-Blind, Randomized, Comparative Study of Itraconazole and Fluconazole as Maintenance Therapy for Preventing Relapse of AIDS-Related Cryptococcal Meningitis (Janssen)
  • Study #26 –  Comparison of Fluconazole and Amphotericin B for Candidemia in Non-Neutropenic Patients (Pfizer)
  • Study #27 –  A Randomized Comparative Trial of Induction Therapy with Amphotericin B plus Flucytosine versus Fluconazole plus Flucytosine followed by Consolidation Therapy with Fluconazole for Acute Cryptococcal Meningitis in Non-AIDS Patients (NIAID) (Closed due to poor enrollment)
  • Study #28 –  A Randomized Comparison of Itraconazole and Placebo in the Prevention of Histoplasmosis in Patients with Human Immunodeficiency Virus Infection (Janssen)
  • Study #29 –  A Study to Compare the Safety and Efficacy of AmBisome with Conventional Amphotericin B for Induction Therapy of Histoplasmosis in Patients with AIDS. (NeXstar 104-24/ FujisawaUSA).
  • Study #30 –  An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects (Janssen)
  • Study #31 –  Open, Non-Comparative Study of Itraconazole in Patients with Coccidioidal  Meningitis  (Withdrawn as an MSG study, rejected by NIAID)
  • Study #32 –  Comparative Trial of AmBisome Versus Amphotericin B in the Empiric Treatment of the Febrile Neutropenic Patients. (Fujisawa 94-0-002)
  • Study #33 –  An Open, ComparativeMulti-Center Study of Fluconazole Versus Fluconazole
  • Plus Amphotericin B in the Treatment of Candidemia and its Consequences in Non-Neutropenic Patients (Pfizer R-0437).  
  • Study #34 –  Multi-center, Hospital-based Candidemia Surveillance Project (MSG).
  • Study #35 –  MSGHospital Survey of Aspergillosis (MSG).
  • Study #36 –  Case Control Study of Risk Factors for Histoplasmosis in HIV Infected Patients. (Joint MSG/CDC Study).
  • Study #37 –  A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Cyclodextrin Solution to Placebo in the Treatment of Aspergilloma (NIAID)  (Closed due to poor enrollment). 
  •  Study #38 –  A Pharmacokinetic Study of Oral Itraconazole (Cyclodextrin Solution) in Bone Marrow Transplant Recipients (NIAID) (Closed due to drug toxicity) 
  • Study # 39 – A Retrospective Review of Cryptococcosis in Non-HIV Infected Patients.  (Withdrawn as an MSG study and completed as a FTSG study)
  • Study #40 –  A Phase IV Randomized Study of the Use of Fluconazole as Chronic Suppressive Therapy Versus Episodic Therapy in HIV Positive Subjects with Recurrent Oropharyngeal Candidiasis (ACTG 323/Pfizer R-0512).
  • Study #41 –  A Phase II Study of Filgrastim in Combination with Fluconazole for the Treatment of Candidemia and/or Invasive Candidiasis (Amgen)  (Closed due to poor enrollment.)
  • Study #42 –  A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome7 for Empirical Antifungal Therapy in Immunocompromised Patients with Persistent Fever and Neutropenia (Pfizer # 603).
  • Study #43 –  Phase I Evaluation of the Safety and Pharmacodynamic Activity of a Murine Derived Anticryptococcal Antibody in Patients Who Have Recovered from AIDS-Associated Cryptococcal Meningitis (NIAID). (Study terminated prior to determining the Maximum Tolerated Dose; Study drug reached its expiration date.)
  • Study #44 –  Invasive Fungal Infections in Liver Transplant Recipients: A Randomized Double-Blind Trial Comparing AmBisome and Fluconazole in the High Risk Group and an Observational Cohort Study in the Low Risk Group.  (NIAID).  Low risk cohort final report submitted.  Final Report of the High Risk Cohort pending.  (Low risk cohort completed enrollment; High risk cohort closed due to poor enrollment.)
  • Study #45 –  A Randomized, Open Label, Comparative, Multicenter Study of Voriconazole versus Conventional Amphotericin B Followed by Fluconazole in the Treatment of Candidemia in Non-Neutropenic Subjects (Pfizer #608) (Decommissioned as an MSG Study in April 1999 secondary to OPRR issues.)
  • Study #46 – A Phase III, Randomized, Double-Blind, Comparative Trial of FK 463 Versus Fluconazole for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoietic Stem Cell Transplant.  (Fujisawa #98-0-050).
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