Invasive CryptococcosisPhase 4NCT01656382
Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex
A Phase 4 study testing ABLC in people with Invasive Cryptococcosis, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine if initial therapy with ABLC at 10/mg/kg/d for 7 days are at least effective as ABLC at 5.0 mg/kg/d X 14 days as induction treatment of patients with disseminated cryptococcosis and HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Cryptococcosis
- What is being tested?
- ABLC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jan 2010
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cryptococcal meningitis based on any of the following:
- Cerebrospinal fluid positive for C. neoformans
- Cerebrospinal fluid positive for cryptococcal antigen
- Male or female 18 years of age or older.
- All female patients must be non-lactating and have a negative serum pregnancy test at time of screening. Females of childbearing potential must be using a medically acceptable method of contraception and agree to continue its use during the study period, or must be one year postmenopausal, or have been surgically sterilized.
- Willing and able to give a signed informed consent, or have a legally authorized representative who is willing or able to give consent
Who cannot join
- A history or evidence of hypersensitivity to AmB or any of its metabolites.
- A history or evidence of any psychiatric, neurological metabolic, or other chronic condition, which in the investigator's opinion, would make the patient unsuitable for the study or interfere with the evaluation of ABLC.
- Inability to comply with the procedures of the study.
- Patients who have received greater than 72 hours of therapy with another systemic antifungal agent within 2 weeks prior to enrollment
- Patients with any of the following abnormal laboratory values
- Baseline creatinine clearance of less than 50.
Show all 9Show fewer
- Bilirubin of greater than 5 times the upper limit of normal
- AST or ALT of greater than 10 times the upper limit of normal
- Life expectancy of less than 72 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex at 10 mg/kg/d for 7 Days or 5.0 mg/kg/d for 14 Days as Induction Therapy for Disseminated Cryptococcosis in Patients With HIV
The purpose of this study is to determine if initial therapy with ABLC at 10/mg/kg/d for 7 days are at least effective as ABLC at 5.0 mg/kg/d X 14 days as induction treatment of patients with disseminated cryptococcosis and HIV.
Read the detailed description
This is a randomized, open label, prospective study of ABLC at 5.0 and 10.0 mg/kg/d for treatment of patients with cryptococcal meningitis. Patients will be randomly assigned in a 1:1 ratio to receive 5.0 or 10.0 mg/kg/d of ABLC as induction therapy for cryptococcal meningitis. Patients receiving 10 mg/kg/d doses will be treated with ABLC for 7 days whereas patients receiving ABLC at 5.0 mg/kg/d will receive 14 days of ABLC therapy. After completion of induction therapy subjects will receive long-term fluconazole maintenance therapy at the discretion of the treating physician. The study will be conducted at the Washington Hospital Center
- Conditions
- Invasive Cryptococcosis
- Being tested
- ABLC
- Keywords
- ABLC, cryptococcosis
- Medical subject headings
- Cryptococcosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABLCDrug
| Study group | Role | What they receive |
|---|---|---|
| 5 mg/kg/d ABLC x 14 days | Active comparator | 5 mg/kg/d of Amphotericin B Lipid Complex for 14 days Receives: Drug: ABLC |
| 10/kg/kg/d x 7 days | Experimental | 10 mg/kg/d of Amphotericin B Lipid Complex for 7 days Receives: Drug: ABLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Time to Sterilization of CSF
Secondary outcomes (1)
Infusion related and renal toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startJan 2007
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive CryptococcosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Enzon Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Shmuel Shoham, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656382
- Sponsor's protocol ID
- 2006-273
- Status last verified
- Feb 2021
- First submitted
- 24 Apr 2007
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex at 10 mg/kg/d for 7 Days or 5.0 mg/kg/d for 14 Days as Induction Therapy for Disseminated Cryptococcosis in Patients With HIV
- ClinicalTrials.gov ID
- NCT01656382
- Acronym / sponsor ID
- 2006-273
- Conditions
- Invasive Cryptococcosis
- Keywords
- ABLC, cryptococcosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Enzon Pharmaceuticals, Inc.
- Study start
- Jan 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 Aug 2012 (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 determine if initial therapy with ABLC at 10/mg/kg/d for 7 days are at least effective as ABLC at 5.0 mg/kg/d X 14 days as induction treatment of patients with disseminated cryptococcosis and HIV.
Detailed description
This is a randomized, open label, prospective study of ABLC at 5.0 and 10.0 mg/kg/d for treatment of patients with cryptococcal meningitis. Patients will be randomly assigned in a 1:1 ratio to receive 5.0 or 10.0 mg/kg/d of ABLC as induction therapy for cryptococcal meningitis. Patients receiving 10 mg/kg/d doses will be treated with ABLC for 7 days whereas patients receiving ABLC at 5.0 mg/kg/d will receive 14 days of ABLC therapy. After completion of induction therapy subjects will receive long-term fluconazole maintenance therapy at the discretion of the treating physician. The study will be conducted at the Washington Hospital Center
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 mg/kg/d ABLC x 14 days | Active comparator | Drug: ABLC5 mg/kg/d of Amphotericin B Lipid Complex for 14 days |
| 10/kg/kg/d x 7 days | Experimental | Drug: ABLC10 mg/kg/d of Amphotericin B Lipid Complex for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of cryptococcal meningitis based on any of the following:
- Male or female 18 years of age or older.
- All female patients must be non-lactating and have a negative serum pregnancy test at time of screening. Females of childbearing potential must be using a medically acceptable method of contraception and agree to continue its use during the study period, or must be one year postmenopausal, or have been surgically sterilized.
- Willing and able to give a signed informed consent, or have a legally authorized representative who is willing or able to give consent
Key exclusion criteria (9 listed)
- A history or evidence of hypersensitivity to AmB or any of its metabolites.
- A history or evidence of any psychiatric, neurological metabolic, or other chronic condition, which in the investigator's opinion, would make the patient unsuitable for the study or interfere with the evaluation of ABLC.
- Inability to comply with the procedures of the study.
- Patients who have received greater than 72 hours of therapy with another systemic antifungal agent within 2 weeks prior to enrollment
- Patients with any of the following abnormal laboratory values
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 |
|---|---|---|
| ABLC | Drug | 10/kg/kg/d x 7 days, 5 mg/kg/d ABLC x 14 days |
Primary outcome
Survival
Time to Sterilization of CSF
1 secondary outcome
Infusion related and renal toxicity
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
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.
Shmuel Shoham, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ABLC in people with Invasive Cryptococcosis, run by Medstar Health Research Institute at 1 site in United States.
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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Survival. The study lists 2 primary outcomes in all. 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 17 Feb 2021.