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Vietnam Cryptococcal Retention in Care Study Version 1.0 — CRICS  

Meningitis, Cryptococcal Clinical Trial

Official title:
Evaluation of a Public Health Strategy to Improve Survival of HIV Infected Patients

Clinical Trial Summary

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.

Clinical Trial Description

This is multicenter prospective cohort evaluation of the implementation of a cryptococcal antigen (CrAg) screening program in Vietnam. 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) and followed up for 12 months with clinical assessments and the collection of routine and supplemental survey data. Those who are CrAg-positive, but have no features of central nervous system (CNS) disease, will be treated with high-dose fluconazole. Those with symptoms of CNS disease will be treated according to national guidelines. Survival, retention in care, and other clinical outcomes will be documented for patients who test CrAg-positive and are treated with fluconazole and those who test CrAg-negative. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02334670
Study type Observational
Source National Hospital for Tropical Diseases, Hanoi, Vietnam
Contact
Status Active, not recruiting
Phase N/A
Start date August 14, 2015
Completion date March 31, 2018
View Details
See also
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Completed NCT00000708 - Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis N/A
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Completed NCT00002019 - Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome N/A
Completed NCT00002113 - A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis. N/A