Meningitis, CryptococcalPhase 2NCT00012467
Safety and Antifungal Activity of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Cryptococcal Meningitis
A Phase 2 study testing Itraconazole, Flucytosine and Fluconazole in people with Meningitis, Cryptococcal and HIV Infections, run by InterMune at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Meningitis, Cryptococcal, HIV Infections
- What is being tested?
- Itraconazole, Flucytosine and Fluconazole
- How many people
- 60 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Jan 2000to Jul 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
UMDNJ - New Jersey Med School / Cooper Hosp
Camden, New Jersey, 08103
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
Univ of Texas / Med School at Houston
Houston, Texas, 77030
Univ of Med & Dentistry of New Jersey
Newark, New Jersey, 07103
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284
Washington Univ
St Louis, Missouri, 63108
About this study
Official 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
The purpose of this study is to examine the antifungal activity of recombinant interferon-gamma 1b (rIFN-gamma 1b) given with standard antifungal therapy.
Read the detailed description
Patients are randomized into 1 of 3 parallel groups for a 3-arm, 2-stage, double-blind and dose-ranging study for 14 weeks. In Stage 1, patients are hospitalized for 14 days of acute therapy. Patients receive rIFN-gamma 1b or placebo sc 3 times per week, intravenous (IV) AMB daily, and with or without oral 5-FC every 6 hours. Patients who have the ability to take oral medications, who do not have any significant clinical deterioration during the previous 14 days, and who meet the eligibility criteria can progress to Stage 2. In Stage 2 patients receive 84 days of consolidation therapy (56 days with study drug and 28 days of follow-up). On an outpatient basis, patients receive either placebo or 1 of 2 doses of rIFN-gamma 1b sc 3 times per week, and oral fluconazole daily or oral itraconazole 2 times a day.
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Being tested
- Itraconazole, Flucytosine, Fluconazole, Amphotericin B, Interferon gamma-1b
- Keywords
- Interferon-gamma, Recombinant, Injections, Subcutaneous, Itraconazole, Dose-Response Relationship, Drug, Fluconazole, Flucytosine, Antifungal Agents, Amphotericin B, Meningitis, Cryptococcal
- Medical subject headings
- Meningitis, Cryptococcal, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItraconazoleDrug
FlucytosineDrug
FluconazoleDrug
Amphotericin BDrug
Interferon gamma-1bDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startJan 2000
- Study completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningitis, CryptococcalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- InterMune
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00012467
- Sponsor's protocol ID
- B013
- Other IDs
- GIMY-001
- Status last verified
- May 2009
- First submitted
- 9 Mar 2001
- Last updated
- 3 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00012467
- Acronym / sponsor ID
- B013
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Keywords
- Interferon-gamma, Recombinant, Injections, Subcutaneous, Itraconazole, Dose-Response Relationship, Drug, Fluconazole, Flucytosine, Antifungal Agents, Amphotericin B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- InterMuneIndustry (pharma, biotech, devices)
- Study start
- Jan 2000
- Study completion
- Jul 2001 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the antifungal activity of recombinant interferon-gamma 1b (rIFN-gamma 1b) given with standard antifungal therapy.
Detailed description
Patients are randomized into 1 of 3 parallel groups for a 3-arm, 2-stage, double-blind and dose-ranging study for 14 weeks. In Stage 1, patients are hospitalized for 14 days of acute therapy. Patients receive rIFN-gamma 1b or placebo sc 3 times per week, intravenous (IV) AMB daily, and with or without oral 5-FC every 6 hours. Patients who have the ability to take oral medications, who do not have any significant clinical deterioration during the previous 14 days, and who meet the eligibility criteria can progress to Stage 2. In Stage 2 patients receive 84 days of consolidation therapy (56 days with study drug and 28 days of follow-up). On an outpatient basis, patients receive either placebo or 1 of 2 doses of rIFN-gamma 1b sc 3 times per week, and oral fluconazole daily or oral itraconazole 2 times a day.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Itraconazole | Drug | – |
| Flucytosine | Drug | – |
| Fluconazole | Drug | – |
| Amphotericin B | Drug | – |
| Interferon gamma-1b | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Itraconazole, Flucytosine and Fluconazole in people with Meningitis, Cryptococcal and HIV Infections, run by InterMune at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2009.