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

Cryptococcal Meningitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955862
• Other study ID #: 3U01GH000758-02S1
• Status: Completed
• Phase: Phase 1
• First received: October 28, 2016
• Last updated: March 27, 2018
• Start date: June 2015
• Est. completion date: September 2017

Study information

• Verified date: March 2018
• Source: National Hospital for Tropical Diseases, Hanoi, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

CRICS financial report for the first budget year of the study

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1177
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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

Related Conditions & MeSH terms

• Cryptococcal Meningitis
• Meningitis
• Meningitis, Cryptococcal

Intervention

Other:
• Vietnam Cryptococcal Retention in Care Study (CRICS)
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

Locations

Country	Name	City	State
Vietnam	National hospital for tropical diseases	Ham Zong

Sponsors (1)

Lead Sponsor	Collaborator
National Hospital for Tropical Diseases, Hanoi, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients who have advanced HIV disease (CD4 <100)		12 months
Primary	Prevalence of CrAg-positivity among HIV patients with advanced disease		12 months
Primary	The proportion of patients who have no new opportunistic infections at 12 months		12 months
Primary	Mortality rate among HIV patients with advanced disease		12 months
Secondary	The proportion of patients with advanced HIV disease who retain in HIV care at 6 months and 12 months		Up to 12 months