Meningitis, Cryptococcal Clinical Trial
— CRICSOfficial title:
Evaluation of a Public Health Strategy to Improve Survival of HIV Infected Patients
Verified date | September 2017 |
Source | National Hospital for Tropical Diseases, Hanoi, Vietnam |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
It is hypothesized that implementing plasma CrAg screening in clinics providing routine HIV care will enable identification of Vietnamese adult patients with advanced HIV (CD4 ≤100 cells/μL) who have early cryptococcal disease, enable prompt preemptive treatment with high-dose fluconazole, and improve survival.
Status | Active, not recruiting |
Enrollment | 2612 |
Est. completion date | March 31, 2018 |
Est. primary completion date | March 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Vietnam | National Hospital for Tropical Diseases | Hanoi |
Lead Sponsor | Collaborator |
---|---|
National Hospital for Tropical Diseases, Hanoi, Vietnam | Centers for Disease Control and Prevention |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Six (6) and (12) month all-cause and CM-related mortality among patients who screen CrAg-positive and CrAg-negative | Up to 12 months after recruitment | ||
Primary | Proportion of all patients tested for plasma CrAg who have positive results | Up to 12 months after recruitment | ||
Secondary | Percent of patients with HIV-related hospitalizations at 6 and 12 months | 12 months after recruitment | ||
Secondary | Percent of patients with new AIDS-defining OIs/conditions at 6 and 12 months | 12 months after recruitment | ||
Secondary | Causes of death | 12 months after recruitment | ||
Secondary | Six (6) and (12) month retention among patients who screen CrAg-positive and CrAg-negative | 12 months after recruitment | ||
Secondary | Percentage of patients with CD4= 100 cells/µL who are lost to follow-up or have incomplete documentation | 12 months after recruitment | ||
Secondary | % of patients with no documented clinic visit 30, 60, and 90 days after date of the scheduled clinic appointment | 12 months after recruitment |
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