NCT02955862

Brief Summary

CRICS financial report for the first budget year of the study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,177

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

2.3 years

First QC Date

October 28, 2016

Last Update Submit

March 27, 2018

Conditions

Cryptococcal Meningitis

Keywords

Cryptococcal antigenemiaCryptococcal meningitisHIV/AIDS

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

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

    Up to 12 months

Study Arms (1)

Assigned Interventions Antifungals Patients with symptoms

OTHER

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)

Interventions

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

Assigned Interventions Antifungals Patients with symptoms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥ 18 years
  • Confirmed HIV infection using National Testing Algorithm
  • CD4 ≤100 cells/μL
  • Able to provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National hospital for tropical diseases

Ham Zong, Vietnam

Location

Related Publications (1)

  • 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.

    PMID: 34446679DERIVED

MeSH Terms

Conditions

Meningitis, CryptococcalAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Meningitis, FungalCentral Nervous System Fungal InfectionsMycosesBacterial Infections and MycosesInfectionsCryptococcosisCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Nguyen V Kinh, Dr

    NHTD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead Coordinator

Study Record Dates

First Submitted

October 28, 2016

First Posted

November 4, 2016

Study Start

June 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

March 29, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)