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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02955862 |
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Date of registration:
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28/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Vietnam Cryptococcal Retention in Care Study (CRICS) Federal Financial Report
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Scientific title:
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Vietnam Cryptococcal Retention in Care Study (CRICS) Federal Financial Report From June 2015 to June 2016 |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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1177 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02955862 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Vietnam
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Contacts
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Name:
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Nguyen V Kinh, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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NHTD |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cryptococcal Meningitis
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Intervention(s)
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Other: Vietnam Cryptococcal Retention in Care Study (CRICS)
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Primary Outcome(s)
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Prevalence of CrAg-positivity among HIV patients with advanced disease
[Time Frame: 12 months]
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The proportion of patients who have no new opportunistic infections at 12 months
[Time Frame: 12 months]
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The proportion of patients who have advanced HIV disease (CD4 <100)
[Time Frame: 12 months]
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Mortality rate among HIV patients with advanced disease
[Time Frame: 12 months]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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3U01GH000758-02S1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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