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

March 27, 2018 updated by: Vu Quoc Dat, National Hospital for Tropical Diseases, Hanoi, Vietnam

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

CRICS financial report for the first budget year of the study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

1177

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ham Zong, Vietnam
        • National Hospital for Tropical Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Hospital for Tropical Diseases, Hanoi, Vietnam

Investigators

  • Principal Investigator: Nguyen V Kinh, Dr, NHTD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

October 28, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimate)

November 4, 2016

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3U01GH000758-02S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cryptococcal Meningitis

Clinical Trials on Vietnam Cryptococcal Retention in Care Study (CRICS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe