Meningitis, CryptococcalCRICSNCT02334670
Vietnam Cryptococcal Retention in Care Study Version 1.0
An observational study of Meningitis, Cryptococcal and Central Nervous System Fungal Infections, run by National Hospital for Tropical Diseases, Hanoi, Vietnam at 1 site in Vietnam.
Trial summary
It is hypothesized that implementing plasma CrAg screening in clinics providing routine HIV care will enable identification of Vietnamese adult patients with advanced HIV (CD4 ≤100 cells/μL) who have early cryptococcal disease, enable prompt preemptive treatment with high-dose fluconazole, and improve survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningitis, Cryptococcal, Central Nervous System Fungal Infections, Central Nervous System Infections
- What is being tested?
- Fluconazole
- Type of treatment
- Pill or oral medicine
- How many people
- 2,612 participants
- Where
- 1 siteVietnam
- Study dates
- 14 Aug 2015to 31 Mar 2018
- Phase
- Observational
- 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
Study population: Newly registering and ART-naive patients with advanced HIV infection
Who may be able to join
- Aged ≥ 18 years
- Confirmed HIV infection using National Testing Algorithm
- CD4 ≤100 cells/μL
- Able to provide written informed consent
Who cannot join
- History of prior CM
- Receipt of systemic antifungal medication for more than 4 consecutive weeks within the past 6 months
- Currently taking ART or history of ART for more than 4 weeks within the past year
- Known to be currently pregnant or planning to become pregnant during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Public Health Strategy to Improve Survival of HIV Infected Patients
It is hypothesized that implementing plasma CrAg screening in clinics providing routine HIV care will enable identification of Vietnamese adult patients with advanced HIV (CD4 ≤100 cells/μL) who have early cryptococcal disease, enable prompt preemptive treatment with high-dose fluconazole, and improve survival.
Read the detailed description
This is multicenter prospective cohort evaluation of the implementation of a cryptococcal antigen (CrAg) screening program in Vietnam. HIV-infected patients with CD4 ≤100 cells/μL who present for HIV care at outpatient clinics (OPCs) in Vietnam where CrAg screening is offered will be recruited into the study. Study participants will be screened for cryptococcal antigen using the Lateral Flow Assay (LFA) and followed up for 12 months with clinical assessments and the collection of routine and supplemental survey data. Those who are CrAg-positive, but have no features of central nervous system (CNS) disease, will be treated with high-dose fluconazole. Those with symptoms of CNS disease will be treated according to national guidelines. Survival, retention in care, and other clinical outcomes will be documented for patients who test CrAg-positive and are treated with fluconazole and those who test CrAg-negative.
- Conditions
- Meningitis, Cryptococcal, Central Nervous System Fungal Infections, Central Nervous System Infections, Meningitis, Fungal
- Being tested
- Fluconazole
- Keywords
- cryptococcal meningitis, HIV, AIDS, Fluconazole
- Medical subject headings
- Meningitis, Cryptococcal, Central Nervous System Fungal Infections, Central Nervous System Infections, Meningitis, Fungal, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
HIV-infected patients with CD4 ≤100 cells/μL who present for HIV care at outpatient clinics (OPCs) in Vietnam where CrAg screening is offered will be recruited into the study. Study participants will be screened for cryptococcal antigen using the Lateral Flow Assay (LFA). Those who are CrAg-positive, but have no features of central nervous system (CNS) disease, will be treated with high-dose fluconazole.
| Study group | Role | What they receive |
|---|---|---|
| CrAg(+) and CM(+) | Patients with symptoms of CNS disease will be treated according to Vietnam national guidelines for HIV/AIDS management. Receives: Drug: Fluconazole | |
| CrAg(+) and CM(-) | Patients with CrAg(+) and without CM symptoms will be treated with high-dose fluconazole. The initial dosage of fluconazole will be 900 mg taken each day for 2 weeks. This will be followed by fluconazole 450 mg orally each day for 8 weeks. Finally, maintenance treatment with fluconazole 200mg orally each (2 tablets of 100 mg procured especially for the study) day will continue until CD4 >200 cells/µL for at least 6 months. Receives: Drug: Fluconazole | |
| CrAg negative | Patients with CrAg negative results will be managed as other HIV positive patients according to the national guidelines Receives: Drug: Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six (6) and (12) month all-cause and CM-related mortality among patients who screen CrAg-positive and CrAg-negative
Measured: Up to 12 months after recruitment
Proportion of all patients tested for plasma CrAg who have positive results
Measured: Up to 12 months after recruitment
Secondary outcomes (6)
Percent of patients with HIV-related hospitalizations at 6 and 12 months
Measured: 12 months after recruitment
Percent of patients with new AIDS-defining OIs/conditions at 6 and 12 months
Measured: 12 months after recruitment
Causes of death
Measured: 12 months after recruitment
Six (6) and (12) month retention among patients who screen CrAg-positive and CrAg-negative
Measured: 12 months after recruitment
Percentage of patients with CD4≤ 100 cells/μL who are lost to follow-up or have incomplete documentation
Measured: 12 months after recruitment
% of patients with no documented clinic visit 30, 60, and 90 days after date of the scheduled clinic appointment
Measured: 12 months after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study start14 Aug 2015
- Primary completion31 Mar 2018 (estimated)
- Study completion31 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningitis, CryptococcalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,612 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Hospital for Tropical Diseases, Hanoi, Vietnam
- Sponsor type
- Other government
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Nguyen Van Kinh, MD, PhD, Principal investigator, National Hospital for Tropical Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334670
- Sponsor's protocol ID
- 1U01GH000758
- Acronym
- CRICS
- Status last verified
- Sep 2017
- First submitted
- 5 Jan 2015
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Please contact PI for any enquiries
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Public Health Strategy to Improve Survival of HIV Infected Patients
- ClinicalTrials.gov ID
- NCT02334670
- Acronym / sponsor ID
- CRICS / 1U01GH000758
- Conditions
- Meningitis, Cryptococcal, Central Nervous System Fungal Infections, Central Nervous System Infections, Meningitis, Fungal
- Keywords
- cryptococcal meningitis, HIV, AIDS, Fluconazole
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,612 participants (estimated)
- Lead sponsor
- National Hospital for Tropical Diseases, Hanoi, VietnamOther government
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 14 Aug 2015 (actual)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 8 Jan 2015 (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.
It is hypothesized that implementing plasma CrAg screening in clinics providing routine HIV care will enable identification of Vietnamese adult patients with advanced HIV (CD4 ≤100 cells/μL) who have early cryptococcal disease, enable prompt preemptive treatment with high-dose fluconazole, and improve survival.
Detailed description
This is multicenter prospective cohort evaluation of the implementation of a cryptococcal antigen (CrAg) screening program in Vietnam. HIV-infected patients with CD4 ≤100 cells/μL who present for HIV care at outpatient clinics (OPCs) in Vietnam where CrAg screening is offered will be recruited into the study. Study participants will be screened for cryptococcal antigen using the Lateral Flow Assay (LFA) and followed up for 12 months with clinical assessments and the collection of routine and supplemental survey data. Those who are CrAg-positive, but have no features of central nervous system (CNS) disease, will be treated with high-dose fluconazole. Those with symptoms of CNS disease will be treated according to national guidelines. Survival, retention in care, and other clinical outcomes will be documented for patients who test CrAg-positive and are treated with fluconazole and those who test CrAg-negative.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CrAg(+) and CM(+) | – | Drug: FluconazolePatients with symptoms of CNS disease will be treated according to Vietnam national guidelines for HIV/AIDS management. |
| CrAg(+) and CM(-) | – | Drug: FluconazolePatients with CrAg(+) and without CM symptoms will be treated with high-dose fluconazole. The initial dosage of fluconazole will be 900 mg taken each day for 2 weeks. This will be followed by fluconazole 450 mg orally each day for 8 weeks. Finally, maintenance treatment with fluconazole 200mg orally each (2 tablets of 100 mg procured especially for the study) day will continue until CD4 >200 cells/µL for at least 6 months. |
| CrAg negative | – | Drug: FluconazolePatients with CrAg negative results will be managed as other HIV positive patients according to the national guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly registering and ART-naive patients with advanced HIV infection
Key inclusion criteria (4 listed)
- Aged ≥ 18 years
- Confirmed HIV infection using National Testing Algorithm
- CD4 ≤100 cells/μL
- Able to provide written informed consent
Key exclusion criteria (4 listed)
- History of prior CM
- Receipt of systemic antifungal medication for more than 4 consecutive weeks within the past 6 months
- Currently taking ART or history of ART for more than 4 weeks within the past year
- Known to be currently pregnant or planning to become pregnant during the study period
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 |
|---|---|---|
| FluconazoleHIV-infected patients with CD4 ≤100 cells/μL who present for HIV care at outpatient clinics (OPCs) in Vietnam where CrAg screening is offered will be recruited into the study. Study participants will be screened for cryptococcal antigen using the Lateral Flow Assay (LFA). Those who are CrAg-positive, but have no features of central nervous system (CNS) disease, will be treated with high-dose fluconazole. | Drug | CrAg negative, CrAg(+) and CM(+), CrAg(+) and CM(-) |
Primary outcome
Six (6) and (12) month all-cause and CM-related mortality among patients who screen CrAg-positive and CrAg-negative
Time frame: Up to 12 months after recruitment
Proportion of all patients tested for plasma CrAg who have positive results
Time frame: Up to 12 months after recruitment
6 secondary outcomes
Percent of patients with HIV-related hospitalizations at 6 and 12 months
Time frame: 12 months after recruitment
Percent of patients with new AIDS-defining OIs/conditions at 6 and 12 months
Time frame: 12 months after recruitment
Causes of death
Time frame: 12 months after recruitment
Six (6) and (12) month retention among patients who screen CrAg-positive and CrAg-negative
Time frame: 12 months after recruitment
Percentage of patients with CD4≤ 100 cells/μL who are lost to follow-up or have incomplete documentation
Time frame: 12 months after recruitment
% of patients with no documented clinic visit 30, 60, and 90 days after date of the scheduled clinic appointment
Time frame: 12 months after recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Individual participant dataSharing planned: No. Please contact PI for any enquiries
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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.
Nguyen Van Kinh, MD, PhD principal investigator
National Hospital for Tropical Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningitis, Cryptococcal and Central Nervous System Fungal Infections, run by National Hospital for Tropical Diseases, Hanoi, Vietnam at 1 site in Vietnam.
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 4 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 13 Sep 2017. 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 Vietnam. 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?
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?
Six (6) and (12) month all-cause and CM-related mortality among patients who screen CrAg-positive and CrAg-negative (time frame: Up to 12 months after recruitment). 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 13 Sep 2017.