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

Phase 1CompletedNCT02955862

National Hospital for Tropical Diseases, Hanoi, Vietnam1,177 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

1,177

Conditions

Cryptococcal Meningitis

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National hospital for tropical diseases

Ham Zong, Vietnam

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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