Talaromyces in Human Immunodeficiency Virus NegativeCSHHTVASITNCT03827278
Comparative Study of Human Immunodeficiency Virus Negative Host Talaromyces Between Voriconazole and Amphotericin Sequential Itraconazole Therapy
A study testing Voriconazole in people with Talaromyces in Human Immunodeficiency Virus Negative and To Compare Voriconazole and Amphotericin Sequential Itraconazole Therapy, run by Guangxi Medical University at 1 site in China.
Trial summary
Through a multi-center large-sample non-randomized controlled study, the effect of voriconazole, amphotericin B sequential itraconazole therapy on Talaromyces in Human Immunodeficiency Virus（HIV）negative hosts were compared to clarify whether the two therapies were equivalent; A comprehensive efficacy evaluation… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Talaromyces in Human Immunodeficiency Virus Negative, To Compare Voriconazole and Amphotericin Sequential Itraconazole Therapy, To Dynamically Monitor the Anti-Interferon-γ Autoantibodies
- What is being tested?
- Voriconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2018to 30 Dec 2021
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-negative adults (≥18 years of age) who diagnosis of talaromyces that was confirmed by either microscopy or culture
- Must be able to swallow tablets
Who cannot join
- Pregnancy, central nervous system involvement assessed either clinically or by analyses of cerebrospinal fluid
- An allergy to voriconazole, itraconazole or amphotericin
- The concomitant use of certain medications that interact with voriconazole, itraconazole or amphotericin
- An alanine aminotransferase or aspartate aminotransferase level of more than 400 U per liter
- An absolute neutrophil count of less than 500 per cubic millimeter
- A creatinine clearance of less than 30 ml per minute (calculated by the method of Cockcroft and Gault)
Show all 10Show fewer
- a concurrent diagnosis of cryptococcal meningitis
- concurrent treatment with rifampicin
- previous treatment for talaromyces for more than 48 hours
- HIV positive who diagnosis of talaromyces.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangxi Medical University
Nanning, Guangxi, 530021
Ye Qiu, M.D, 0771-5356702, yeqiu2013graduated@163.com
Jianquan Zhang, Professor
About this study
Official title: Human Immunodeficiency Virus Negative Host Talaromyces Between Voriconazole and Amphotericin B Sequential Itraconazole Therapy
Through a multi-center large-sample non-randomized controlled study, the effect of voriconazole, amphotericin B sequential itraconazole therapy on Talaromyces in Human Immunodeficiency Virus（HIV）negative hosts were compared to clarify whether the two therapies were equivalent; A comprehensive efficacy evaluation system and standard treatment program was established to provide a basis for standardized treatment of Talaromyces in Human Immunodeficiency Virus negative hosts.The observational indicators included: 2-week all-cause mortality; 24-week all-cause mortality; clinical improvement time; level of decrease of fungus in the blood culture medium two weeks before treatment; recurrence; appearance of adverse drug reaction at the level 3 and above. Dynamically monitor the immune cells and factors like anti-Interferon-γ autoantibodies, Interferon-γ, Th1/Th2, and Th17/Treg in the HIV-negative Talaromyces host microenvironment, and observe the host's immune status and its change. 3. study the effect of absence of Interferon-γ and Interferon-γ Receptor (IFN-γR）on the activation and function of anti-Interferon-γ autoantibodies, Th1/Th2, and Th17/Treg by establishing a Talaromyces mouse model that knocks out the Interferon-γ and IFN-γR gene and a IFN-γ silenced cell model; Study the effect of anti-IFN-γ autoantibody on the activation and function of IFN-γ、Th1/Th2、Th17/Treg by increasing its titer in vitro and vivo; determine by which path the anti-IFN-γ autoantibody of HIV-negative host influences its immune regulation mechanism; finally, the intervention effect of IFN-γ on high titer anti-IFN-γ autoantibodies is studied, providing a new idea for immunotargeted therapy.
- Conditions
- Talaromyces in Human Immunodeficiency Virus Negative, To Compare Voriconazole and Amphotericin Sequential Itraconazole Therapy, To Dynamically Monitor the Anti-Interferon-γ Autoantibodies
- Being tested
- Voriconazole
- Keywords
- Talaromyces, voriconazole, Amphotericin Sequential Itraconazole therapy, anti-Interferon-γ autoantibodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VoriconazoleDrug
Also called Amphotericin, Itraconazole
6mg/kg bid, was given on the first day, followed by intravenous 4mg/kg bid for 6 days, followed by oral Valconazole 200mg bid for at least 6 months.
Amphotericin B sequential itraconazole group (intravenous amphotericin, dose 0.7 - 1.0 mg / kg / d, 14 days, then changed oral itraconazole 200 mg bid for 10 weeks, after which 100 mg bid maintenance Until CD4+ T cells are greater than 100 cells/L for at least 6 months
| Study group | Role | What they receive |
|---|---|---|
| HIV Negative Host talaromyces using Voriconazole | Experimental | Voriconazole On the first day, 6 mg/kg bid was given, and then 4 mg/kg bid was given intravenously for 6 days, and then oral voriconazole 200 mg bid was administered to maintain treatment for at least 6 months. Receives: Drug: Voriconazole |
| HIV Negative talaromyces AMB Sequential Itraconazole | Experimental | Amphotericin B (AMB) sequential itraconazole group (intravenous amphotericin, dose 0.7 - 1.0 mg / kg / d, 14 days, then changed oral itraconazole 200 mg bid for 10 weeks, after which 100 mg bid maintenance Until cluster of differentiation 4 (CD4+ T) cells are greater than 100 cells/L for at least 6 months Receives: Drug: Voriconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with all-cause mortality
defined as the absolute risk of death from any cause during the first 2 weeks
Measured: up to 2 weeks
Number of Participants with all-cause mortality
defined as the absolute risk of death from any cause during 24 weeks
Measured: up to 24 weeks
Number of Participants with Clinical resolution of talaromyces
Clinical resolution of talaromyces was defined as a temperature of less than 38°C (100°F) for 3 days, resolution of skin lesions, and tertile blood cultures. Early fungicidal activity was defined as the rate of decline in blood T. marneffei colony forming units (CFUs).
Measured: 3 days
Number of Participants with Early fungicidal activity
defined as the rate of decline in blood T. marneffei CFUs from sterical blood cultures obtained during the first 2 weeks.
Measured: up to 2 weeks
Number of Participants with Relapse of talaromyces
defined as the recurrence of symptoms and a positive fungal culture from any sterile site that led to reinduction of therapy in patients who had achieved clinical resolution.
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start30 Dec 2018
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Talaromyces in Human Immunodeficiency Virus NegativeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Guangxi Medical University, Second Affiliated Hospital of Guangzhou Medical University, The Fourth People's Hospital of Nanning, Guilin Medical College, Nanning Second People's Hospital
- Responsible party
- Principal investigator, Qiu Ye, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827278
- Sponsor's protocol ID
- TSM-AMB-VOR-2018
- Acronym
- CSHHTVASIT
- Status last verified
- Feb 2019
- First submitted
- 25 Jan 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Le T, Kinh NV, Cuc NTK, Tung NLN, Lam NT, Thuy PTT, Cuong DD, Phuc PTH, Vinh VH, Hanh DTH, Tam VV, Thanh NT, Thuy TP, Hang NT, Long HB, Nhan HT, Wertheim HFL, Merson L, Shikuma C, Day JN, Chau NVV, Farrar J, Thwaites G, Wolbers M; IVAP Investigators. A Trial of Itraconazole or Amphotericin B for HIV-Associated Talaromycosis. N Engl J Med. 2017 Jun 15;376(24):2329-2340. doi: 10.1056/NEJMoa1613306.
PubMed 28614691
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Immunodeficiency Virus Negative Host Talaromyces Between Voriconazole and Amphotericin B Sequential Itraconazole Therapy
- ClinicalTrials.gov ID
- NCT03827278
- Acronym / sponsor ID
- CSHHTVASIT / TSM-AMB-VOR-2018
- Conditions
- Talaromyces in Human Immunodeficiency Virus Negative, To Compare Voriconazole and Amphotericin Sequential Itraconazole Therapy, To Dynamically Monitor the Anti-Interferon-γ Autoantibodies
- Keywords
- Talaromyces, voriconazole, Amphotericin Sequential Itraconazole therapy, anti-Interferon-γ autoantibodies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Guangxi Medical University, Second Affiliated Hospital of Guangzhou Medical University, The Fourth People's Hospital of Nanning, Guilin Medical College, Nanning Second People's Hospital
- Study start
- 30 Dec 2018 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 1 Feb 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.
Through a multi-center large-sample non-randomized controlled study, the effect of voriconazole, amphotericin B sequential itraconazole therapy on Talaromyces in Human Immunodeficiency Virus（HIV）negative hosts were compared to clarify whether the two therapies were equivalent; A comprehensive efficacy evaluation system and standard treatment program was established to provide a basis for standardized treatment of Talaromyces in Human Immunodeficiency Virus negative hosts.The observational indicators included: 2-week all-cause mortality; 24-week all-cause mortality; clinical improvement time; level of decrease of fungus in the blood culture medium two weeks before treatment; recurrence; appearance of adverse drug reaction at the level 3 and above. Dynamically monitor the immune cells and factors like anti-Interferon-γ autoantibodies, Interferon-γ, Th1/Th2, and Th17/Treg in the HIV-negative Talaromyces host microenvironment, and observe the host's immune status and its change. 3. study the effect of absence of Interferon-γ and Interferon-γ Receptor (IFN-γR）on the activation and function of anti-Interferon-γ autoantibodies, Th1/Th2, and Th17/Treg by establishing a Talaromyces mouse model that knocks out the Interferon-γ and IFN-γR gene and a IFN-γ silenced cell model; Study the effect of anti-IFN-γ autoantibody on the activation and function of IFN-γ、Th1/Th2、Th17/Treg by increasing its titer in vitro and vivo; determine by which path the anti-IFN-γ autoantibody of HIV-negative host influences its immune regulation mechanism; finally, the intervention effect of IFN-γ on high titer anti-IFN-γ autoantibodies is studied, providing a new idea for immunotargeted therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV Negative Host talaromyces using Voriconazole | Experimental | Drug: VoriconazoleVoriconazole On the first day, 6 mg/kg bid was given, and then 4 mg/kg bid was given intravenously for 6 days, and then oral voriconazole 200 mg bid was administered to maintain treatment for at least 6 months. |
| HIV Negative talaromyces AMB Sequential Itraconazole | Experimental | Drug: VoriconazoleAmphotericin B (AMB) sequential itraconazole group (intravenous amphotericin, dose 0.7 - 1.0 mg / kg / d, 14 days, then changed oral itraconazole 200 mg bid for 10 weeks, after which 100 mg bid maintenance Until cluster of differentiation 4 (CD4+ T) cells are greater than 100 cells/L for at least 6 months |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV-negative adults (≥18 years of age) who diagnosis of talaromyces that was confirmed by either microscopy or culture
- Must be able to swallow tablets
Key exclusion criteria (10 listed)
- Pregnancy, central nervous system involvement assessed either clinically or by analyses of cerebrospinal fluid
- An allergy to voriconazole, itraconazole or amphotericin
- The concomitant use of certain medications that interact with voriconazole, itraconazole or amphotericin
- An alanine aminotransferase or aspartate aminotransferase level of more than 400 U per liter
- An absolute neutrophil count of less than 500 per cubic millimeter
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 |
|---|---|---|
| VoriconazoleAlso: Amphotericin, Itraconazole6mg/kg bid, was given on the first day, followed by intravenous 4mg/kg bid for 6 days, followed by oral Valconazole 200mg bid for at least 6 months. Amphotericin B sequential itraconazole group (intravenous amphotericin, dose 0.7 - 1.0 mg / kg / d, 14 days, then changed oral itraconazole 200 mg bid for 10 weeks, after which 100 mg bid maintenance Until CD4+ T cells are greater than 100 cells/L for at least 6 months | Drug | HIV Negative Host talaromyces using Voriconazole, HIV Negative talaromyces AMB Sequential Itraconazole |
Primary outcome
Number of Participants with all-cause mortality
Time frame: up to 2 weeks
defined as the absolute risk of death from any cause during the first 2 weeks
Number of Participants with all-cause mortality
Time frame: up to 24 weeks
defined as the absolute risk of death from any cause during 24 weeks
Number of Participants with Clinical resolution of talaromyces
Time frame: 3 days
Clinical resolution of talaromyces was defined as a temperature of less than 38°C (100°F) for 3 days, resolution of skin lesions, and tertile blood cultures. Early fungicidal activity was defined as the rate of decline in blood T. marneffei colony forming units (CFUs).
Number of Participants with Early fungicidal activity
Time frame: up to 2 weeks
defined as the rate of decline in blood T. marneffei CFUs from sterical blood cultures obtained during the first 2 weeks.
Number of Participants with Relapse of talaromyces
Time frame: an average of 1 year
defined as the recurrence of symptoms and a positive fungal culture from any sterile site that led to reinduction of therapy in patients who had achieved clinical resolution.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Results publication: PubMed 28614691Le T, Kinh NV, Cuc NTK, Tung NLN, Lam NT, Thuy PTT, Cuong DD, Phuc PTH, Vinh VH, Hanh DTH, Tam VV, Thanh NT, Thuy TP, Hang NT, Long HB, Nhan HT, Wertheim HFL, Merson L, Shikuma C, Day JN, Chau NVV, Farrar J, Thwaites G, Wolbers M; IVAP Investigators. A Trial of Itraconazole or Amphotericin B for HIV-Associated Talaromycosis. N Engl J Med. 2017 Jun 15;376(24):2329-2340. doi: 10.1056/NEJMoa1613306.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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 study testing Voriconazole in people with Talaromyces in Human Immunodeficiency Virus Negative and To Compare Voriconazole and Amphotericin Sequential Itraconazole Therapy, run by Guangxi Medical 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 2 inclusion and 10 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 5 Feb 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with all-cause mortality (time frame: up to 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03827278, which also lists 1 linked publication.
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 5 Feb 2019.