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

Primary Purpose

Cryptococcal Meningitis

Status
Completed
Phase
Phase 1
Locations
Vietnam
Study Type
Interventional
Intervention
Vietnam Cryptococcal Retention in Care Study (CRICS)
Sponsored by
National Hospital for Tropical Diseases, Hanoi, Vietnam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cryptococcal Meningitis focused on measuring Cryptococcal antigenemia, Cryptococcal meningitis, HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National hospital for tropical diseases

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Assigned Interventions Antifungals Patients with symptoms

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 28, 2016
Last Updated
March 27, 2018
Sponsor
National Hospital for Tropical Diseases, Hanoi, Vietnam
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1. Study Identification

Unique Protocol Identification Number
NCT02955862
Brief Title
Vietnam Cryptococcal Retention in Care Study (CRICS) Federal Financial Report
Official Title
Vietnam Cryptococcal Retention in Care Study (CRICS) Federal Financial Report From June 2015 to June 2016
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Hospital for Tropical Diseases, Hanoi, Vietnam

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryptococcal Meningitis
Keywords
Cryptococcal antigenemia, Cryptococcal meningitis, HIV/AIDS

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assigned Interventions Antifungals Patients with symptoms
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Vietnam Cryptococcal Retention in Care Study (CRICS)
Intervention Description
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
Primary Outcome Measure Information:
Title
The proportion of patients who have advanced HIV disease (CD4 <100)
Time Frame
12 months
Title
Prevalence of CrAg-positivity among HIV patients with advanced disease
Time Frame
12 months
Title
The proportion of patients who have no new opportunistic infections at 12 months
Time Frame
12 months
Title
Mortality rate among HIV patients with advanced disease
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nguyen V Kinh, Dr
Organizational Affiliation
NHTD
Official's Role
Principal Investigator
Facility Information:
Facility Name
National hospital for tropical diseases
City
Ham Zong
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34446679
Citation
Dat VQ, Lyss S, Dung NTH, Hung LM, Pals SL, Anh HTV, Kinh NV, Bateganya M. Prevalence of Advanced HIV Disease, Cryptococcal Antigenemia, and Suboptimal Clinical Outcomes Among Those Enrolled in Care in Vietnam. J Acquir Immune Defic Syndr. 2021 Dec 15;88(5):487-496. doi: 10.1097/QAI.0000000000002786.
Results Reference
derived

Learn more about this trial

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

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