Cryptococcal MeningitisPhase 3NCT04140461
AmB Dose for Cryptococcal Meningitis
A Phase 3 study testing Amphotericin B and Flucytosine in people with Cryptococcal Meningitis and HIV Infections, run by Shanghai Public Health Clinical Center at 1 site in China.
Trial summary
Cryptococcal meningitis (CM) is one of the leading opportunistic infections and one of the most common causes of death in AIDS patients. Amphotericin B (AmB) is the corner stone in CM treatment. The effect of AmB was dose-dependent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryptococcal Meningitis, HIV Infections
- What is being tested?
- Amphotericin B and Flucytosine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2020to 30 Apr 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed HIV infection
- Naive to antiretroviral therapy
- Cryptococcal antigen, smear or culture positive in cerebrospinal fluid
- Agree to participate the study
Who cannot join
- Having receiving antifungal treatment for ≥3 days
- ALT or AST > 5* upper limit of detection (ULD), or neutrophil< 0.5*10E9 cells/L, or hemoglobin < 90g/L or platelet <50*10E9/L or serum creatinine > ULD
- Pregnancy or breastfeeding
- Concomitant medications that are contraindicated with any research drug
- Any other contraindications for using amphotericin B or 5FC
- Inability to follow-up as accessed by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
About this study
Official title: Antifungal Treatment of Cryptococcal Meningitis
Cryptococcal meningitis (CM) is one of the leading opportunistic infections and one of the most common causes of death in AIDS patients.
Amphotericin B (AmB) is the corner stone in CM treatment. The effect of AmB was dose-dependent. Recent retrospective study indicated that longer duration rather than higher dose of AmB is necessary to reduce the mortality of CM. We aimed to explore the efficacy and safety of small dose but longer duration of AmB for the treatment of HIV-associated CM.
- Conditions
- Cryptococcal Meningitis, HIV Infections
- Being tested
- Amphotericin B, Flucytosine
- Keywords
- HIV infection, Cryptococcal Meningitis, Amphotericin B
- 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.
Amphotericin BDrug
Also called Antiretroviral therapy
The trial group and the control group received AmB 0.5mg/kg for 4 weeks and 0.7mg/kg for 2 weeks respectively.
FlucytosineDrug
The trial group and the control group received 100mg/kg for 4 weeks and for 2 weeks respectively.
| Study group | Role | What they receive |
|---|---|---|
| Trial | Experimental | Amphotericin B 0.5 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 4 weeks Receives: Drug: Amphotericin B; Drug: Flucytosine |
| Control | Active comparator | Amphotericin B 0.7 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 2 weeks Receives: Drug: Amphotericin B; Drug: Flucytosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects died at weeks 48
Mortality in intent to treat population
Measured: 48 weeks after randomization
Secondary outcomes (2)
Number of subjects with CSF culture positive for Cryptococcus at weeks 2
Antifungal Activity
Measured: 2 weeks after randomization
Number of subjects with disability at weeks 48
Disability rate in intent to treat population
Measured: 48 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start2 Jan 2020 (estimated)
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryptococcal MeningitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jun Chen, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140461
- Sponsor's protocol ID
- AMBDOSE
- Status last verified
- Oct 2019
- First submitted
- 24 Oct 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antifungal Treatment of Cryptococcal Meningitis
- ClinicalTrials.gov ID
- NCT04140461
- Acronym / sponsor ID
- AMBDOSE
- Conditions
- Cryptococcal Meningitis, HIV Infections
- Keywords
- HIV infection, Cryptococcal Meningitis, Amphotericin B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Study start
- 2 Jan 2020 (estimated)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 25 Oct 2019 (actual)
- 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.
Cryptococcal meningitis (CM) is one of the leading opportunistic infections and one of the most common causes of death in AIDS patients.
Amphotericin B (AmB) is the corner stone in CM treatment. The effect of AmB was dose-dependent. Recent retrospective study indicated that longer duration rather than higher dose of AmB is necessary to reduce the mortality of CM. We aimed to explore the efficacy and safety of small dose but longer duration of AmB for the treatment of HIV-associated CM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial | Experimental | Drug: Amphotericin B, Drug: FlucytosineAmphotericin B 0.5 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 4 weeks |
| Control | Active comparator | Drug: Amphotericin B, Drug: FlucytosineAmphotericin B 0.7 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed HIV infection
- Naive to antiretroviral therapy
- Cryptococcal antigen, smear or culture positive in cerebrospinal fluid
- Agree to participate the study
Key exclusion criteria (6 listed)
- Having receiving antifungal treatment for ≥3 days
- ALT or AST > 5* upper limit of detection (ULD), or neutrophil< 0.5*10E9 cells/L, or hemoglobin < 90g/L or platelet <50*10E9/L or serum creatinine > ULD
- Pregnancy or breastfeeding
- Concomitant medications that are contraindicated with any research drug
- Any other contraindications for using amphotericin B or 5FC
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 |
|---|---|---|
| Amphotericin BAlso: Antiretroviral therapyThe trial group and the control group received AmB 0.5mg/kg for 4 weeks and 0.7mg/kg for 2 weeks respectively. | Drug | Control, Trial |
| FlucytosineThe trial group and the control group received 100mg/kg for 4 weeks and for 2 weeks respectively. | Drug | Control, Trial |
Primary outcome
Number of subjects died at weeks 48
Time frame: 48 weeks after randomization
Mortality in intent to treat population
2 secondary outcomes
Number of subjects with CSF culture positive for Cryptococcus at weeks 2
Time frame: 2 weeks after randomization
Number of subjects with disability at weeks 48
Time frame: 48 weeks after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
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Optimizing Care for Cryptococcal Antigenemia: Evaluation of Short Course Fluconazole and ART Timing Among CrAg+ Persons With Low Titers
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amphotericin B and Flucytosine in people with Cryptococcal Meningitis and HIV Infections, run by Shanghai Public Health Clinical Center at 1 site in China.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Oct 2019. 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 China. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Chen, M.D (+86-21-37990333 ext. 3222, qtchenjun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects died at weeks 48 (time frame: 48 weeks after randomization). 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 29 Oct 2019.