Cryptococcal MeningitisEarly Phase 1TITOCNCT04072640
Three Induction Treatments on Cryptococcal Meningitis
A Early Phase 1 study testing Voriconazole 200mg, amphotericin B deoxycholate (0.4-0.5mg/kg/d) and Amphotericin B-deoxycholate (0.7-1.0mg/kg/d) in people with Cryptococcal Meningitis and HIV/AIDS, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Three induction treatment strategies [ voriconazole +5FC vs. amphotericin deoxycholate (0.4-0.5 mg/kg/d)+5FC vs. amphotericin deoxycholate (0.7-1.0 mg/kg/d)+5FC ] for HIV-infected patients with cryptococcal meningitis were compared. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cryptococcal Meningitis, HIV/AIDS
- What is being tested?
- Voriconazole 200mg, amphotericin B deoxycholate (0.4-0.5mg/kg/d) and Amphotericin B-deoxycholate (0.7-1.0mg/kg/d)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2021to 1 Dec 2022
- Phase
- Early Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of HIV infection;
- newly diagnosed Cryptococcal Meningitis by positive India ink staining or culture result, or both in cerebrospinal fluid (CSF);
- Anti-viral treatment naïve patients
- anti-fungal treatment naïve patients
Who cannot join
- hepatitis virus co-infection;
- liver cirrhosis;
- congestive heart failure;
- chronic renal disorders;
- chronic obstructive pulmonary disease (COPD);
- Tuberculosis co-infection;
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- malignances
- severe mental and neurological diseases
- Women during pregnancy and lactation
- intraveneous drug user (IDU)
- patients with follow abnormal test results:hemoglobin < 6 g/dl, white blood cell count < 2000 / μl, neutrophil count < 1000 / μl, platelet count < 75000 / μl, blood amylase > 3 times normal level Upper limit, serum creatinine > 1.5 times normal upper limit, aspartate aminotransferase / alanine aminotransferase / alkaline phosphatase > 3 times normal upper limit, total bilirubin > 2 times normal upper limit
- patients who are unwilling to anticipate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect and Safety of Three Initial Introduction Treatments on HIV-infected Patients With Cryptococcal Meningitis: A Multi-center, Random and Prospective Study
Three induction treatment strategies [ voriconazole +5FC vs. amphotericin deoxycholate (0.4-0.5 mg/kg/d)+5FC vs. amphotericin deoxycholate (0.7-1.0 mg/kg/d)+5FC ] for HIV-infected patients with cryptococcal meningitis were compared.
Read the detailed description
HIV-associated cryptococcal meningitis were randomly allocated into three induction treatment as follow: 1) 14 days of voriconazole 200mg bid +5FC, 2) 28 days of amphotericin deoxycholate (0.4-0.5 mg/kg/d) +5FC ; 3）14 days of deoxycholate (0.7-1 mg/kg/d) +5FC). After induction treatment were finished, all groups switched into fluconazole(400mg/d) for two-month consolidation treatment. 14-day early fungicidal rate, 90-day mortality, side effects , and tolerances were compared between three groups.
- Conditions
- Cryptococcal Meningitis, HIV/AIDS
- Being tested
- Voriconazole 200mg, amphotericin B deoxycholate (0.4-0.5mg/kg/d), Amphotericin B-deoxycholate (0.7-1.0mg/kg/d)
- Keywords
- Voriconazole;amphotericin ;cryptococcal meningitis
- Medical subject headings
- Meningitis, Cryptococcal, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voriconazole 200mgDrug
Also called Voriconazole for Cryptococcus
Induction treatment with voriconazole( 400mg/d)+5FC (100mg/kg/d) for 14 days;
amphotericin B deoxycholate (0.4-0.5mg/kg/d)Drug
Also called low dose and long course of Amphotericin B-deoxycholate
Induction treatment with 0.4-0.5mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 28 days
Amphotericin B-deoxycholate (0.7-1.0mg/kg/d)Drug
Also called standard Amphotericin B-deoxycholate for Cryptococcus
Induction treatment with 0.7-1.0mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 14 days
| Study group | Role | What they receive |
|---|---|---|
| voriconazole treatment | Experimental | induction treatment with Voriconazole 200mg bid (IV) + 5FC (100mg/kg/d) for 14 days, consolidation treatment wiht fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d Receives: Drug: Voriconazole 200mg |
| amphotericin treatment (0.7-1.0mg/kg/d) | Active comparator | Induction treatment with amphotericin B 0.7-1.0mg/kg/d + 5FC (100mg/kg/d) for 14 days,consolidation treatment wiht fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d Receives: Drug: Amphotericin B-deoxycholate (0.7-1.0mg/kg/d) |
| amphotericin B treatment (0.4-0.5mg/kg/d) | Experimental | Induction treatment with amphotericin B 0.4-0.5mg/kg/d + 5FC (100mg/kg/d) for 28 days, consolidation treatment with fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d Receives: Drug: amphotericin B deoxycholate (0.4-0.5mg/kg/d) |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day Cryptococcal Meningitis (CM) related mortality
analysis of 90-day CM-related mortality of patients in three induction treatments
Measured: 90 days
Secondary outcomes (4)
Early fungicidal rate in Cerebrospinal fluid (CSF)
Comparison of 2-week CSF early fungicidal activity in three induction treatments
Measured: 2 weeks
creatinine elevation
TO observe the numbers of patients whose creatinine > 110 mmol/L during antifungal therapy
Measured: 0-90 days
Hypokalemia
To observe the rate of hypokalemia in three groups during antifungal therapy
Measured: 0-90 days
anemia
Comparison of the numbers of patients with hemoglobin <120g/L for male or <110g/L for female.
Measured: 0-90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start25 Jan 2021
- Primary completion31 Jul 2022 (estimated)
- Study completion1 Dec 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Wenzhou Central Hospital
- Responsible party
- Sponsor
- Investigators
- Lijun Xu, PH.D, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072640
- Sponsor's protocol ID
- 2018-014-1
- Acronym
- TITOC
- Status last verified
- Jan 2021
- First submitted
- 9 Jun 2019
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 12 months after study finished
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Safety of Three Initial Introduction Treatments on HIV-infected Patients With Cryptococcal Meningitis: A Multi-center, Random and Prospective Study
- ClinicalTrials.gov ID
- NCT04072640
- Acronym / sponsor ID
- TITOC / 2018-014-1
- Conditions
- Cryptococcal Meningitis, HIV/AIDS
- Keywords
- Voriconazole;amphotericin ;cryptococcal meningitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Wenzhou Central Hospital
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 28 Aug 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.
Three induction treatment strategies [ voriconazole +5FC vs. amphotericin deoxycholate (0.4-0.5 mg/kg/d)+5FC vs. amphotericin deoxycholate (0.7-1.0 mg/kg/d)+5FC ] for HIV-infected patients with cryptococcal meningitis were compared.
Detailed description
HIV-associated cryptococcal meningitis were randomly allocated into three induction treatment as follow: 1) 14 days of voriconazole 200mg bid +5FC, 2) 28 days of amphotericin deoxycholate (0.4-0.5 mg/kg/d) +5FC ; 3）14 days of deoxycholate (0.7-1 mg/kg/d) +5FC). After induction treatment were finished, all groups switched into fluconazole(400mg/d) for two-month consolidation treatment. 14-day early fungicidal rate, 90-day mortality, side effects , and tolerances were compared between three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| voriconazole treatment | Experimental | Drug: Voriconazole 200mginduction treatment with Voriconazole 200mg bid (IV) + 5FC (100mg/kg/d) for 14 days, consolidation treatment wiht fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d |
| amphotericin treatment (0.7-1.0mg/kg/d) | Active comparator | Drug: Amphotericin B-deoxycholate (0.7-1.0mg/kg/d)Induction treatment with amphotericin B 0.7-1.0mg/kg/d + 5FC (100mg/kg/d) for 14 days,consolidation treatment wiht fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d |
| amphotericin B treatment (0.4-0.5mg/kg/d) | Experimental | Drug: amphotericin B deoxycholate (0.4-0.5mg/kg/d)Induction treatment with amphotericin B 0.4-0.5mg/kg/d + 5FC (100mg/kg/d) for 28 days, consolidation treatment with fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of HIV infection;
- newly diagnosed Cryptococcal Meningitis by positive India ink staining or culture result, or both in cerebrospinal fluid (CSF);
- Anti-viral treatment naïve patients
- anti-fungal treatment naïve patients
Key exclusion criteria (12 listed)
- hepatitis virus co-infection;
- liver cirrhosis;
- congestive heart failure;
- chronic renal disorders;
- chronic obstructive pulmonary disease (COPD);
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 |
|---|---|---|
| Voriconazole 200mgAlso: Voriconazole for CryptococcusInduction treatment with voriconazole( 400mg/d)+5FC (100mg/kg/d) for 14 days; | Drug | voriconazole treatment |
| amphotericin B deoxycholate (0.4-0.5mg/kg/d)Also: low dose and long course of Amphotericin B-deoxycholateInduction treatment with 0.4-0.5mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 28 days | Drug | amphotericin B treatment (0.4-0.5mg/kg/d) |
| Amphotericin B-deoxycholate (0.7-1.0mg/kg/d)Also: standard Amphotericin B-deoxycholate for CryptococcusInduction treatment with 0.7-1.0mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 14 days | Drug | amphotericin treatment (0.7-1.0mg/kg/d) |
Primary outcome
90-day Cryptococcal Meningitis (CM) related mortality
Time frame: 90 days
analysis of 90-day CM-related mortality of patients in three induction treatments
4 secondary outcomes
Early fungicidal rate in Cerebrospinal fluid (CSF)
Time frame: 2 weeks
creatinine elevation
Time frame: 0-90 days
Hypokalemia
Time frame: 0-90 days
anemia
Time frame: 0-90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: Yes. 12 months after study finished
Related trials for Cryptococcal Meningitis
RecruitingObservational study
Fungal Infection Susceptibility
Cryptococcal Infection, Cryptococcal Pneumonia
RecruitingObservational study
Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
Idiopathic CD4+ Lymphocytopenia, Cryptococcal Meningitis
Not yet recruitingPhase 3
Optimizing Care for Cryptococcal Antigenemia: Evaluation of Short Course Fluconazole and ART Timing Among CrAg+ Persons With Low Titers
Cryptococcal Antigenemia, HIV-1-infection
RecruitingPhase 2/3
Platform Trial For Cryptococcal Meningitis (PLATFORM-CM)
Hiv, Cryptococcal Meningitis
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Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia
Cryptococcal Meningitis
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.
Lijun Xu, PH.D principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Voriconazole 200mg, amphotericin B deoxycholate (0.4-0.5mg/kg/d) and Amphotericin B-deoxycholate (0.7-1.0mg/kg/d) in people with Cryptococcal Meningitis and HIV/AIDS, run by First Affiliated Hospital of Zhejiang University 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 12 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 2 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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?
90-day Cryptococcal Meningitis (CM) related mortality (time frame: 90 days). 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 2 Feb 2021.