A Phase 1 interventional study of Vietnam Cryptococcal Retention in Care Study (CRICS) in Cryptococcal Meningitis, sponsored by National Hospital for Tropical Diseases, Hanoi, Vietnam. Completed at 1 site in Vietnam. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by National Hospital for Tropical Diseases, Hanoi, Vietnam · Phase 1, Interventional, and Screening
CRICS financial report for the first budget year of the study
Vietnam Cryptococcal Retention in Care Study (CRICS) federal financial report for the first budget year of the study
54 studies on the registry are indexed under Meningitis, Cryptococcal; 6 are open to participants now.
This study's enrollment of 1,177 is above the median of 143 across 35 interventional studies indexed under Meningitis, Cryptococcal.
Browse Meningitis, Cryptococcal studies →National Hospital for Tropical Diseases, Hanoi, Vietnam is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: 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
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
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
Plan to share: No
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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National Hospital for Tropical Diseases, Hanoi, Vietnam