HIV/AIDSNCT03267407
Vietnam Cryptococcal Retention in Care Study - Version 2.1
An observational study of HIV/AIDS and Cryptococcal Meningitis, run by National Hospital for Tropical Diseases, Hanoi, Vietnam at 1 site in Vietnam.
Trial summary
This is a multicenter prospective cohort evaluation of the implementation of a cryptococcal antigen (CrAg) screening program at selected outpatient HIV clinics (OPCs) and network laboratories in Vietnam. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Cryptococcal Meningitis, Opportunistic Infections, HIV Related
- What is being tested?
- Preemptive high-dose Fluconazole
- How many people
- 1,184 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: Patients with advanced HIV infection (CD4<100 cells/microliters) who are eligible to inclusion and exclusion criteria are recruited and followed up into the study.
Who may be able to join
- Aged ≥ 18 years (having passed 18th birthday using Western calendar)
- Confirmed HIV infection using National Testing Algorithm
- CD4 ≤100 cells/μL
- Able to provide written informed consent
- Enrolled at and plan to receive ongoing outpatient care at one of the selected study OPCs
Who cannot join
- History of prior CM
- Receipt of systemic antifungal medication for more than 4 consecutive weeks within the past 6 months
- Receipt of ART for more than 4 consecutive weeks within the past year
- For CrAg-positive patients only: 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: Vietnam Cryptococcal Retention in Care Study (CRICS) - Version 2.1
This is a multicenter prospective cohort evaluation of the implementation of a cryptococcal antigen (CrAg) screening program at selected outpatient HIV clinics (OPCs) and network laboratories in Vietnam.
Read the detailed description
The project will be implemented in 2 phases; Phase 1: From August 2015 to March 2017 [projected], HIV-infected patients who present for HIV care and undergo CD4 testing will be reviewed to determine the proportion of newly presenting patients with advanced disease (CD4 ≤100 cells/μL). Reflex CrAg screening will be performed using Lateral Flow Assay (LFA) for those with CD4≤100 cells/μL, per Vietnam national guidelines.
Patients with CD4≤100 cells/μL who present for antiretroviral treatment (ART) at a study OPCs-CRICS Sites- will be recruited into the longitudinal study and followed up with assessments and the collection of routine and supplemental data for 12 months or through September 2017 (whichever comes sooner). 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. Data from those tested at participating labs but not eligible for enrollment in the longitudinal study will contribute to the estimation of the prevalence of CrAg.
Phase 2: From April 2017 to September 2017, a cost and cost-effectiveness analysis of CrAg screening will be conducted, a routine screening will be continued at existing sites and expanded to additional sites (preferentially to hospitals affiliated with Phase 1 OPCs and to other OPCs whose CD4 testing is conducted at laboratories already conducting CrAg screening as part of Phase 1). CrAg tests will also be made available to screen all patients with CD4≤100 cells/μL including those who are treatment-experienced. The test will also be made available for use among symptomatic patients for diagnostic purposes, including cerebral spinal fluid (CSF) and blood testing. Investigators will monitor prevalence at each testing site, but screened patients will not be enrolled in longitudinal follow-up. Phase 2 will last for at least 6 months based on the availability of funding and fluconazole for those who screen CrAg positive and the availability/stability of CD4 testing.
[Note that follow up of patients enrolled in Phase 1 will continue during this time period, but is considered to be part of Phase 1 rather than Phase 2. Also, sites included in Phase 2 may change over time as a result of the instability of CD4 testing (e.g., if participating laboratories stop conducting CD4 testing, those sites might no longer be included; if participating laboratories begin CD4 testing for other sites, those sites might be included).]
- Conditions
- HIV/AIDS, Cryptococcal Meningitis, Opportunistic Infections, HIV Related, Cryptococcosis, Mycosis; Opportunistic, Mycosis Fungoides
- Being tested
- Preemptive high-dose Fluconazole
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Meningitis, Cryptococcal, AIDS-Related Opportunistic Infections, Cryptococcosis, Mycoses, Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preemptive high-dose FluconazoleOther
Also called Preemptive Fluconazole
Patients with advanced HIV diseases are screened for Cryptococcal Antigen using LFA CrAg tests. Then patients with CrAg positivity and without meningitis are given preemptive high-dose fluconazole to prevent the development of cryptococcal meningitis, which is one of the leading cause of death among immunocompromized patients.
| Study group | Role | What they receive |
|---|---|---|
| CrAg(+) and CM(-) | (1) Patients with CrAg positive without meningitis results will receive preemptive high-dose fluconazole to prevent developing meningitis. Receives: Other: Preemptive high-dose Fluconazole | |
| CrAg(+) and CM(+) | (2) Patients with CrAg positive and meningitis results will receive standard treatment for cryptococcal meningitis, following national guidelines. Receives: Other: Preemptive high-dose Fluconazole | |
| CrAg(-) | (3) Patients with CrAg negative results will be managed as other HIV infected patients with the standard of care, following national guidelines. Receives: Other: Preemptive high-dose Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of HIV-infected adults who have CD4 count ≤ 100 cells/μL
The number of HIV-infected adults with CD4 count ≤ 100 cells/μL divided by the total number of HIV-infected patients.
Measured: August 2015 to March 2017
Prevalence of CrAg-positivity among HIV-infected patients with CD4 ≤100 cells/μL
The number of CrAg-positivity divided by the number HIV-infected patients with CD4 ≤100 cells/μL
Measured: August 2015 to March 2017
Clinical outcomes including common causes of mortality for people living with HIV (PLHIV) with CD4 ≤ 100 cells/μL who are enrolled in a programmatic rollout of screening for CrAg
Clinical outcomes include HIV-related hospitalization, causes of death, new AIDS defining opportunistic infections at 6 and 12 month.
Measured: August 2015 to March 2017
Twelve (12) month all-causes and cryptococcal meningitis (CM)-related mortality among patients who screen CrAg-positive and CrAg-negative
The 12-month mortality among two groups of HIV-infected patients with CD4 ≤ 100 cells/μL who are enrolled in care and treatment:
- Those who are CrAg-positive and are treated with high-dose fluconazole;
- Those who are CrAg-negative.
Measured: August 2015 to March 2017
Secondary outcomes (8)
Twelve (12) month retention among patients who screen CrAg-positive and CrAg-negative
The 12-month retention in care among two groups of HIV-infected patients with CD4 ≤ 100 cells/μL who are newly enrolled in care and treatment.
Measured: August 2015 to March 2017
Challenges associated with implementation of routine plasma CrAg screening in clinics providing HIV care
The challenges associated with implementation may include lost to follow up, incomplete documentation, and poor retention in care.
Measured: August 2015 to March 2018
Lessons learned with participating sites
This will be delivered at reflection and transition workshops with participating sites.
Measured: August 2015 to March 2018
Total costs and unit cost per person screened, per CrAg+ treated by site, lab facility type, and cost component.
The costs of implementing CrAg screening based on data to be collected at 22 participating clinics participating in Phase 1 and provider costs associated with CM treatment.
Measured: August 2015 to March 2017
Incremental cost-effectiveness ratio (cost per CM death averted and cost per quality adjusted life year (QALY))
The incremental cost-effectiveness analysis of CrAg screening compared with a standard of care (no CrAg screening, and treatment for symptomatic CM only).
Measured: August 2015 to March 2017
Total cost savings and amount of financial resources required to implement CrAg screening
Potential cost savings from implementing CrAg screening and financial resources required to implement CrAg screening under different scale-up scenarios and for national rollout
Measured: August 2015 to March 2017
Proportion of stored samples that test positive for TmAg
The prevalence of Talaromyces marneffei antigenemia (TmAg) in stored CRICS samples using the Mannose phosphate isomerase 1 (MP1) enzyme-linked immunosorbent assay (ELISA)
Measured: August 2015 to March 2017
Six (6) and twelve (12) month all-causes and Talaromyces marneffei-related mortality among patients who screen TmAg-positive and TmAg-negative
The impact of TmAg positivity on mortality
Measured: August 2015 to March 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- 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 HIV/AIDSStudies 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
- 1,184 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Hospital for Tropical Diseases, Hanoi, Vietnam
- Sponsor type
- Other government
- Collaborators
- Centers for Disease Control and Prevention, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
- Responsible party
- Principal investigator, Vu Quoc Dat, National Hospital for Tropical Diseases, Hanoi, Vietnam
- Investigators
- Kinh V Nguyen, MD, Principal investigator, National Hospital for Tropical Diseases, Hanoi, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267407
- Sponsor's protocol ID
- 5U01GH000758-03
- Status last verified
- Sep 2017
- First submitted
- 27 Aug 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Please contact principal investigators for any inquiries.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vietnam Cryptococcal Retention in Care Study (CRICS) - Version 2.1
- ClinicalTrials.gov ID
- NCT03267407
- Acronym / sponsor ID
- 5U01GH000758-03
- Conditions
- HIV/AIDS, Cryptococcal Meningitis, Opportunistic Infections, HIV Related, Cryptococcosis, Mycosis; Opportunistic, Mycosis Fungoides
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,184 participants (actual)
- Lead sponsor
- National Hospital for Tropical Diseases, Hanoi, VietnamOther government
- Collaborators
- Centers for Disease Control and Prevention, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
- Study start
- 14 Aug 2015 (actual)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 30 Aug 2017 (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.
This is a multicenter prospective cohort evaluation of the implementation of a cryptococcal antigen (CrAg) screening program at selected outpatient HIV clinics (OPCs) and network laboratories in Vietnam.
Detailed description
The project will be implemented in 2 phases; Phase 1: From August 2015 to March 2017 [projected], HIV-infected patients who present for HIV care and undergo CD4 testing will be reviewed to determine the proportion of newly presenting patients with advanced disease (CD4 ≤100 cells/μL). Reflex CrAg screening will be performed using Lateral Flow Assay (LFA) for those with CD4≤100 cells/μL, per Vietnam national guidelines.
Patients with CD4≤100 cells/μL who present for antiretroviral treatment (ART) at a study OPCs-CRICS Sites- will be recruited into the longitudinal study and followed up with assessments and the collection of routine and supplemental data for 12 months or through September 2017 (whichever comes sooner). 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. Data from those tested at participating labs but not eligible for enrollment in the longitudinal study will contribute to the estimation of the prevalence of CrAg.
Phase 2: From April 2017 to September 2017, a cost and cost-effectiveness analysis of CrAg screening will be conducted, a routine screening will be continued at existing sites and expanded to additional sites (preferentially to hospitals affiliated with Phase 1 OPCs and to other OPCs whose CD4 testing is conducted at laboratories already conducting CrAg screening as part of Phase 1). CrAg tests will also be made available to screen all patients with CD4≤100 cells/μL including those who are treatment-experienced. The test will also be made available for use among symptomatic patients for diagnostic purposes, including cerebral spinal fluid (CSF) and blood testing. Investigators will monitor prevalence at each testing site, but screened patients will not be enrolled in longitudinal follow-up. Phase 2 will last for at least 6 months based on the availability of funding and fluconazole for those who screen CrAg positive and the availability/stability of CD4 testing.
[Note that follow up of patients enrolled in Phase 1 will continue during this time period, but is considered to be part of Phase 1 rather than Phase 2. Also, sites included in Phase 2 may change over time as a result of the instability of CD4 testing (e.g., if participating laboratories stop conducting CD4 testing, those sites might no longer be included; if participating laboratories begin CD4 testing for other sites, those sites might be included).]
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CrAg(+) and CM(-) | – | Other: Preemptive high-dose Fluconazole(1) Patients with CrAg positive without meningitis results will receive preemptive high-dose fluconazole to prevent developing meningitis. |
| CrAg(+) and CM(+) | – | Other: Preemptive high-dose Fluconazole(2) Patients with CrAg positive and meningitis results will receive standard treatment for cryptococcal meningitis, following national guidelines. |
| CrAg(-) | – | Other: Preemptive high-dose Fluconazole(3) Patients with CrAg negative results will be managed as other HIV infected patients with the standard of care, following national guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced HIV infection (CD4<100 cells/microliters) who are eligible to inclusion and exclusion criteria are recruited and followed up into the study.
Key inclusion criteria (5 listed)
- Aged ≥ 18 years (having passed 18th birthday using Western calendar)
- Confirmed HIV infection using National Testing Algorithm
- CD4 ≤100 cells/μL
- Able to provide written informed consent
- Enrolled at and plan to receive ongoing outpatient care at one of the selected study OPCs
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
- Receipt of ART for more than 4 consecutive weeks within the past year
- For CrAg-positive patients only: 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 |
|---|---|---|
| Preemptive high-dose FluconazoleAlso: Preemptive FluconazolePatients with advanced HIV diseases are screened for Cryptococcal Antigen using LFA CrAg tests. Then patients with CrAg positivity and without meningitis are given preemptive high-dose fluconazole to prevent the development of cryptococcal meningitis, which is one of the leading cause of death among immunocompromized patients. | Other | CrAg(+) and CM(+), CrAg(+) and CM(-), CrAg(-) |
Primary outcome
Proportion of HIV-infected adults who have CD4 count ≤ 100 cells/μL
Time frame: August 2015 to March 2017
The number of HIV-infected adults with CD4 count ≤ 100 cells/μL divided by the total number of HIV-infected patients.
Prevalence of CrAg-positivity among HIV-infected patients with CD4 ≤100 cells/μL
Time frame: August 2015 to March 2017
The number of CrAg-positivity divided by the number HIV-infected patients with CD4 ≤100 cells/μL
Clinical outcomes including common causes of mortality for people living with HIV (PLHIV) with CD4 ≤ 100 cells/μL who are enrolled in a programmatic rollout of screening for CrAg
Time frame: August 2015 to March 2017
Clinical outcomes include HIV-related hospitalization, causes of death, new AIDS defining opportunistic infections at 6 and 12 month.
Twelve (12) month all-causes and cryptococcal meningitis (CM)-related mortality among patients who screen CrAg-positive and CrAg-negative
Time frame: August 2015 to March 2017
The 12-month mortality among two groups of HIV-infected patients with CD4 ≤ 100 cells/μL who are enrolled in care and treatment: * Those who are CrAg-positive and are treated with high-dose fluconazole; * Those who are CrAg-negative.
8 secondary outcomes
Twelve (12) month retention among patients who screen CrAg-positive and CrAg-negative
Time frame: August 2015 to March 2017
Challenges associated with implementation of routine plasma CrAg screening in clinics providing HIV care
Time frame: August 2015 to March 2018
Lessons learned with participating sites
Time frame: August 2015 to March 2018
Total costs and unit cost per person screened, per CrAg+ treated by site, lab facility type, and cost component.
Time frame: August 2015 to March 2017
Incremental cost-effectiveness ratio (cost per CM death averted and cost per quality adjusted life year (QALY))
Time frame: August 2015 to March 2017
Total cost savings and amount of financial resources required to implement CrAg screening
Time frame: August 2015 to March 2017
Proportion of stored samples that test positive for TmAg
Time frame: August 2015 to March 2017
Six (6) and twelve (12) month all-causes and Talaromyces marneffei-related mortality among patients who screen TmAg-positive and TmAg-negative
Time frame: August 2015 to March 2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Individual participant dataSharing planned: Undecided. Please contact principal investigators for any inquiries.
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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.
Kinh V Nguyen, MD principal investigator
National Hospital for Tropical Diseases, Hanoi, Vietnam
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 HIV/AIDS and Cryptococcal Meningitis, 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 5 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 12 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?
Proportion of HIV-infected adults who have CD4 count ≤ 100 cells/μL (time frame: August 2015 to March 2017). The study lists 4 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 12 Sep 2017.