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NCT Number: NCT02955862

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

CRICS financial report for the first budget year of the study

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Key information

Conditions

Cryptococcal Meningitis Acquired Immunodeficiency Syndrome Bacterial Infections and Mycoses Blood-Borne Infections Central Nervous System Diseases Central Nervous System Fungal Infections Central Nervous System Infections Communicable Diseases Cryptococcosis Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Meningitis Meningitis, Cryptococcal Meningitis, Fungal Mycoses Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National hospital for tropical diseases

Ham Zong, Vietnam

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vietnam Cryptococcal Retention in Care Study (CRICS)

Other

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 outcomes

  1. The proportion of patients who have advanced HIV disease (CD4 <100)

    Time frame: 12 months

  2. Prevalence of CrAg-positivity among HIV patients with advanced disease

    Time frame: 12 months

  3. The proportion of patients who have no new opportunistic infections at 12 months

    Time frame: 12 months

  4. Mortality rate among HIV patients with advanced disease

    Time frame: 12 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

National Hospital for Tropical Diseases, Hanoi, Vietnam

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 4, 2016
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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