Vietnam Cryptococcal Retention in Care Study (CRICS) Federal Financial Report

Study Overview
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Brief Summary
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CRICS financial report for the first budget year of the study

Detailed Description
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Vietnam Cryptococcal Retention in Care Study (CRICS) federal financial report for the first budget year of the study

Official Title
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Vietnam Cryptococcal Retention in Care Study (CRICS) Federal Financial Report From June 2015 to June 2016

Conditions
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Cryptococcal Meningitis

Intervention / Treatment
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* Other: Vietnam Cryptococcal Retention in Care Study (CRICS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥ 18 years Confirmed HIV infection using National Testing Algorithm CD4 ≤100 cells/μL Able to provide written informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Assigned Interventions Antifungals Patients with symptoms<br>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)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who have advanced HIV disease (CD4 <100) |  | 12 months | 
| Prevalence of CrAg-positivity among HIV patients with advanced disease |  | 12 months | 
| The proportion of patients who have no new opportunistic infections at 12 months |  | 12 months | 
| Mortality rate among HIV patients with advanced disease |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with advanced HIV disease who retain in HIV care at 6 months and 12 months |  | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryptococcal antigenemia, Cryptococcal meningitis, HIV/AIDS