NCT00012467

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2000

Shorter than P25 for phase_2

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2001

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 3, 2009

Status Verified

May 1, 2009

First QC Date

March 9, 2001

Last Update Submit

May 29, 2009

Conditions

Meningitis, CryptococcalHIV Infections

Keywords

Interferon-gamma, RecombinantInjections, SubcutaneousItraconazoleDose-Response Relationship, DrugFluconazoleFlucytosineAntifungal AgentsAmphotericin BMeningitis, Cryptococcal

Interventions

ItraconazoleDRUG
FlucytosineDRUG
FluconazoleDRUG
Amphotericin BDRUG
Interferon gamma-1bDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Univ of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Washington Univ

St Louis, Missouri, 63108, United States

Location

UMDNJ - New Jersey Med School / Cooper Hosp

Camden, New Jersey, 08103, United States

Location

Univ of Med & Dentistry of New Jersey

Newark, New Jersey, 07103, United States

Location

Houston Veterans Administration Med Ctr

Houston, Texas, 77030, United States

Location

Univ of Texas / Med School at Houston

Houston, Texas, 77030, United States

Location

Audie L Murphy Veterans Administration Hosp

San Antonio, Texas, 78284, United States

Location

Hosp Nacional dos de Mayo

Lima, Peru

Location

Instituto de Medicina Tropical

Lima, Peru

Location

MeSH Terms

Conditions

Meningitis, CryptococcalHIV Infections

Interventions

ItraconazoleFlucytosineFluconazoleAmphotericin Binterferon gamma-1b

Condition Hierarchy (Ancestors)

Meningitis, FungalCentral Nervous System Fungal InfectionsMycosesBacterial Infections and MycosesInfectionsCryptococcosisCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesCytosinePyrimidinonesPyrimidinesMacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 9, 2001

First Posted

August 31, 2001

Study Start

January 1, 2000

Study Completion

July 1, 2001

Last Updated

June 3, 2009

Record last verified: 2009-05

Locations

US(7)PE(2)