Cryptococcal MeningitisPhase 1NCT02955862
Vietnam Cryptococcal Retention in Care Study (CRICS) Federal Financial Report
A Phase 1 study testing Vietnam Cryptococcal Retention in Care Study (CRICS) in people with Cryptococcal Meningitis, run by National Hospital for Tropical Diseases, Hanoi, Vietnam at 1 site in Vietnam.
Trial summary
CRICS financial report for the first budget year of the study Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cryptococcal Meningitis
- What is being tested?
- Vietnam Cryptococcal Retention in Care Study (CRICS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,177 participants
- Where
- 1 siteVietnam
- Study dates
- Jun 2015to Sep 2017
- Phase
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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: Vietnam Cryptococcal Retention in Care Study (CRICS) Federal Financial Report From June 2015 to June 2016
CRICS financial report for the first budget year of the study
Read the detailed description
Vietnam Cryptococcal Retention in Care Study (CRICS) federal financial report for the first budget year of the study
- Conditions
- Cryptococcal Meningitis
- Being tested
- Vietnam Cryptococcal Retention in Care Study (CRICS)
- Keywords
- Cryptococcal antigenemia, Cryptococcal meningitis, HIV/AIDS
- 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.
Vietnam Cryptococcal Retention in Care Study (CRICS)Other
Drug: Fluconazole 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.
Other Names:
- Fluconazole
| Study group | Role | What they receive |
|---|---|---|
| Assigned Interventions Antifungals Patients with symptoms | Other | Patients with symptoms of CNS disease will be treated according to Vietnam national guidelines for HIV/AIDS management.
For CrAg-positive patients, 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: Other: Vietnam Cryptococcal Retention in Care Study (CRICS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who have advanced HIV disease (CD4 <100)
Measured: 12 months
Prevalence of CrAg-positivity among HIV patients with advanced disease
Measured: 12 months
The proportion of patients who have no new opportunistic infections at 12 months
Measured: 12 months
Mortality rate among HIV patients with advanced disease
Measured: 12 months
Secondary outcomes (1)
The proportion of patients with advanced HIV disease who retain in HIV care at 6 months and 12 months
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startJun 2015
- Primary completionSep 2017
- Study completionSep 2017
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 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 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,177 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Hospital for Tropical Diseases, Hanoi, Vietnam
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vu Quoc Dat, National Hospital for Tropical Diseases, Hanoi, Vietnam
- Investigators
- Nguyen V Kinh, Dr, Principal investigator, NHTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955862
- Sponsor's protocol ID
- 3U01GH000758-02S1
- Status last verified
- Mar 2018
- First submitted
- 28 Oct 2016
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dat VQ, Lyss S, Dung NTH, Hung LM, Pals SL, Anh HTV, Kinh NV, Bateganya M. Prevalence of Advanced HIV Disease, Cryptococcal Antigenemia, and Suboptimal Clinical Outcomes Among Those Enrolled in Care in Vietnam. J Acquir Immune Defic Syndr. 2021 Dec 15;88(5):487-496. doi: 10.1097/QAI.0000000000002786.
PubMed 34446679
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vietnam Cryptococcal Retention in Care Study (CRICS) Federal Financial Report From June 2015 to June 2016
- ClinicalTrials.gov ID
- NCT02955862
- Acronym / sponsor ID
- 3U01GH000758-02S1
- Conditions
- Cryptococcal Meningitis
- Keywords
- Cryptococcal antigenemia, Cryptococcal meningitis, HIV/AIDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,177 participants (actual)
- Lead sponsor
- National Hospital for Tropical Diseases, Hanoi, VietnamOther government
- Study start
- Jun 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 4 Nov 2016 (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.
CRICS financial report for the first budget year of the study
Detailed description
Vietnam Cryptococcal Retention in Care Study (CRICS) federal financial report for the first budget year of the study
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assigned Interventions Antifungals Patients with symptoms | Other | Other: Vietnam Cryptococcal Retention in Care Study (CRICS)Patients with symptoms of CNS disease will be treated according to Vietnam national guidelines for HIV/AIDS management. For CrAg-positive patients, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Vietnam Cryptococcal Retention in Care Study (CRICS)Drug: Fluconazole 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. Other Names: • Fluconazole | Other | Assigned Interventions Antifungals Patients with symptoms |
Primary outcome
The proportion of patients who have advanced HIV disease (CD4 <100)
Time frame: 12 months
Prevalence of CrAg-positivity among HIV patients with advanced disease
Time frame: 12 months
The proportion of patients who have no new opportunistic infections at 12 months
Time frame: 12 months
Mortality rate among HIV patients with advanced disease
Time frame: 12 months
1 secondary outcome
The proportion of patients with advanced HIV disease who retain in HIV care at 6 months and 12 months
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Derived from this study: PubMed 34446679Dat VQ, Lyss S, Dung NTH, Hung LM, Pals SL, Anh HTV, Kinh NV, Bateganya M. Prevalence of Advanced HIV Disease, Cryptococcal Antigenemia, and Suboptimal Clinical Outcomes Among Those Enrolled in Care in Vietnam. J Acquir Immune Defic Syndr. 2021 Dec 15;88(5):487-496. doi: 10.1097/QAI.0000000000002786.
- Individual participant dataSharing planned: No
Related trials for Cryptococcal Meningitis
RecruitingObservational study
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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
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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 V Kinh, Dr principal investigator
NHTD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vietnam Cryptococcal Retention in Care Study (CRICS) in people with 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 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: finished, as of the sponsor's last update on 29 Mar 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of patients who have advanced HIV disease (CD4 <100) (time frame: 12 months). 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?
On the ClinicalTrials.gov record for NCT02955862, 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 29 Mar 2018.