Invasive AspergillosisPhase 3NCT00158730
Study Safety/Efficacy of AmBisome Loading Dose Regimen Versus Standard AmBisome Regimen for Initial Treatment
A Phase 3 study testing AmBisome in people with Invasive Aspergillosis and Other Fungal Infections, run by Gilead Sciences.
Trial summary
To evaluate and compare two AmBisome dosing regimens for the initial treatment of invasive aspergillosis and other filamentous fungal infections diagnosed by modified EORTC criteria in immunocompromised patients, as determined by overall response rates at end of course of treatment. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Invasive Aspergillosis, Other Fungal Infections
- What is being tested?
- AmBisome
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Jan 2005
- Phase
- Phase 3
- 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 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Immunocompromised due to hematologic malignancies, chemotherapy-induced neutropenia, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy (greater than or less than 20 mg of Prednisone or equivalent for greater than or less than 3 weeks), treatment with other immunosuppressant medications, or other acquired or hereditary immunocompromising conditions that place the patients at risk for IFI. Evidence of Proven, Probably or Possible IFFI by modified EORTC criteria. Continued treatment with study drug is contingent upon confirmation of diagnosis of Proven or Probable IFI within 4 working days after study entry.
Who cannot join
- Life expectancy of less than 30 days; chronic IFI (defined as signs/symptoms of IFI present for less 4 weeks preceding entry into study;prior systemic therapy of greater than or less than 4 days with any polyene anti-fungal agent within 14 days of study enrollment;prior systemic therapy of greater than or less than 4 days with non-polyenes for the current, documented IFI. Use of another investigational, unlicensed drug within 30 days of screening or concurrent participation in another clinical trial using an investigational, unlicensed drug; serum creatinine greater than 2 x upper limit of normal (ULN), serum ALT or AST less than 5 x ULN; pregnant or lactating women; history of allergy or serious adverse reaction to any polyene anti-fungal agent.
About this study
Official title: Study of the Safety and Efficacy of AmBisome Loading Dose Regimen Vs. a Standard AmBisome Regimen for Initial Treatment of Invasive Aspergillosis and Other Filamentous Fungal Infections in Immunocompromised Patients
To evaluate and compare two AmBisome dosing regimens for the initial treatment of invasive aspergillosis and other filamentous fungal infections diagnosed by modified EORTC criteria in immunocompromised patients, as determined by overall response rates at end of course of treatment.
Read the detailed description
To evaluate and compare two AmBisome dosing regimens for the initial treatment of invasive aspergillosis and other filamentous fungal infections diagnosed by modified EORTC criteria in immunocompromised patients, as determined by overall response rates at end of course of treatment.
Determine and compare the following parameters for the two treatment arms:
- Safety and tolerability
- Survival rates and the rates of infection relapse at 4 weeks Post Treatment.
- Survival rate at 12 weeks after study entry.
- Time to favorable overall response and time to End of Treatment for patients with favorable overall response.
- Cumulative dose of study drug given through End of Treatment.
- Conditions
- Invasive Aspergillosis, Other Fungal Infections
- Being tested
- AmBisome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmBisomeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate two regimens determined by overall response rates at end of tx.
Secondary outcomes (1)
Compare Safety/tolerability; survival rates/rates of infection relapse at 4 wks post tx; survival rate at 12 wks after study entry; TOVR; time to end of tx for patients w/favorable overall response;cumulative dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2003
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive AspergillosisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 800 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158730
- Sponsor's protocol ID
- GS-131-101
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 18 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety and Efficacy of AmBisome Loading Dose Regimen Vs. a Standard AmBisome Regimen for Initial Treatment of Invasive Aspergillosis and Other Filamentous Fungal Infections in Immunocompromised Patients
- ClinicalTrials.gov ID
- NCT00158730
- Acronym / sponsor ID
- GS-131-101
- Conditions
- Invasive Aspergillosis, Other Fungal Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Study completion
- Jan 2005
- First posted
- 12 Sep 2005 (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.
To evaluate and compare two AmBisome dosing regimens for the initial treatment of invasive aspergillosis and other filamentous fungal infections diagnosed by modified EORTC criteria in immunocompromised patients, as determined by overall response rates at end of course of treatment.
Detailed description
To evaluate and compare two AmBisome dosing regimens for the initial treatment of invasive aspergillosis and other filamentous fungal infections diagnosed by modified EORTC criteria in immunocompromised patients, as determined by overall response rates at end of course of treatment.
Determine and compare the following parameters for the two treatment arms:
- Safety and tolerability
- Survival rates and the rates of infection relapse at 4 weeks Post Treatment.
- Survival rate at 12 weeks after study entry.
- Time to favorable overall response and time to End of Treatment for patients with favorable overall response.
- Cumulative dose of study drug given through End of Treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Immunocompromised due to hematologic malignancies, chemotherapy-induced neutropenia, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy (greater than or less than 20 mg of Prednisone or equivalent for greater than or less than 3 weeks), treatment with other immunosuppressant medications, or other acquired or hereditary immunocompromising conditions that place the patients at risk for IFI. Evidence of Proven, Probably or Possible IFFI by modified EORTC criteria. Continued treatment with study drug is contingent upon confirmation of diagnosis of Proven or Probable IFI within 4 working days after study entry.
Key exclusion criteria (1 listed)
- Life expectancy of less than 30 days; chronic IFI (defined as signs/symptoms of IFI present for less 4 weeks preceding entry into study;prior systemic therapy of greater than or less than 4 days with any polyene anti-fungal agent within 14 days of study enrollment;prior systemic therapy of greater than or less than 4 days with non-polyenes for the current, documented IFI. Use of another investigational, unlicensed drug within 30 days of screening or concurrent participation in another clinical trial using an investigational, unlicensed drug; serum creatinine greater than 2 x upper limit of normal (ULN), serum ALT or AST less than 5 x ULN; pregnant or lactating women; history of allergy or serious adverse reaction to any polyene anti-fungal agent.
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 |
|---|---|---|
| AmBisome | Drug | – |
Primary outcome
Evaluate two regimens determined by overall response rates at end of tx.
1 secondary outcome
Compare Safety/tolerability; survival rates/rates of infection relapse at 4 wks post tx; survival rate at 12 wks after study entry; TOVR; time to end of tx for patients w/favorable overall response;cumulative dose
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 18 Nov 2005.
- Website for AmBisomeLink provided by the sponsor.
- Website for GileadLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AmBisome in people with Invasive Aspergillosis and Other Fungal Infections, run by Gilead Sciences.
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 1 inclusion and 1 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 18 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
Evaluate two regimens determined by overall response rates at end of tx.. It is what the study was designed to measure, not a finding.
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 18 Nov 2005.