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

Sponsor

National Hospital for Tropical Diseases, Hanoi, Vietnam (Other)

Overall Status

Completed

CT.gov ID

NCT02955862

Collaborator

(none)

1,177

Enrollment

Location

Arm

Duration (Months)

43.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

CRICS financial report for the first budget year of the study

Condition or Disease	Intervention/Treatment	Phase
Cryptococcal Meningitis	Other: Vietnam Cryptococcal Retention in Care Study (CRICS)	Phase 1

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

1177 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Assigned Interventions Antifungals Patients with symptoms Patients with symptoms of CNS disease will be treated according to Vietnam national guidelines for HIV/AIDS management. For CrAg-positive patients, the initial dosage of fluconazole will be 900 mg taken each day for 2 weeks. This will be followed by fluconazole 450 mg orally each day for 8 weeks. Finally, maintenance treatment with fluconazole 200mg orally each (2 tablets of 100 mg procured especially for the study) day will continue until CD4 >200 cells/µL for at least 6 months.	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

Arm

Intervention/Treatment

Other: Assigned Interventions Antifungals Patients with symptoms

Patients with symptoms of CNS disease will be treated according to Vietnam national guidelines for HIV/AIDS management. For CrAg-positive patients, the initial dosage of fluconazole will be 900 mg taken each day for 2 weeks. This will be followed by fluconazole 450 mg orally each day for 8 weeks. Finally, maintenance treatment with fluconazole 200mg orally each (2 tablets of 100 mg procured especially for the study) day will continue until CD4 >200 cells/µL for at least 6 months.

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

Outcome Measures

Primary Outcome Measures

The proportion of patients who have advanced HIV disease (CD4 <100) [12 months]
Prevalence of CrAg-positivity among HIV patients with advanced disease [12 months]
The proportion of patients who have no new opportunistic infections at 12 months [12 months]
Mortality rate among HIV patients with advanced disease [12 months]

Secondary Outcome Measures

The proportion of patients with advanced HIV disease who retain in HIV care at 6 months and 12 months [Up to 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National hospital for tropical diseases	Ham Zong		Vietnam

Sponsors and Collaborators

National Hospital for Tropical Diseases, Hanoi, Vietnam

Investigators

Principal Investigator: Nguyen V Kinh, Dr, NHTD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vu Quoc Dat, Lead Coordinator, National Hospital for Tropical Diseases, Hanoi, Vietnam

ClinicalTrials.gov Identifier:

NCT02955862

Other Study ID Numbers:

3U01GH000758-02S1

First Posted:

Nov 4, 2016

Last Update Posted:

Mar 29, 2018

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Vu Quoc Dat, Lead Coordinator, National Hospital for Tropical Diseases, Hanoi, Vietnam

Cryptococcal antigenemia

Cryptococcal meningitis

HIV/AIDS

Additional relevant MeSH terms:

Meningitis, Cryptococcal

Meningitis

Study Results

No Results Posted as of Mar 29, 2018