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Trial record 11 of 53 for:    "Cryptococcosis"

Vietnam Cryptococcal Retention in Care Study - Version 2.1

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ClinicalTrials.gov Identifier: NCT03267407
Recruitment Status : Active, not recruiting
First Posted : August 30, 2017
Last Update Posted : September 12, 2017
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Information provided by (Responsible Party):
Vu Quoc Dat, National Hospital for Tropical Diseases, Hanoi, Vietnam

Brief Summary:
This is a multicenter prospective cohort evaluation of the implementation of a cryptococcal antigen (CrAg) screening program at selected outpatient HIV clinics (OPCs) and network laboratories in Vietnam.

Condition or disease Intervention/treatment
HIV/AIDS Cryptococcal Meningitis Opportunistic Infections, HIV Related Cryptococcosis Mycosis; Opportunistic Mycosis Fungoides Other: Preemptive high-dose Fluconazole

Detailed Description:

The project will be implemented in 2 phases; Phase 1: From August 2015 to March 2017 [projected], HIV-infected patients who present for HIV care and undergo CD4 testing will be reviewed to determine the proportion of newly presenting patients with advanced disease (CD4 ≤100 cells/μL). Reflex CrAg screening will be performed using Lateral Flow Assay (LFA) for those with CD4≤100 cells/μL, per Vietnam national guidelines.

Patients with CD4≤100 cells/μL who present for antiretroviral treatment (ART) at a study OPCs—CRICS Sites— will be recruited into the longitudinal study and followed up with assessments and the collection of routine and supplemental data for 12 months or through September 2017 (whichever comes sooner). Those who are CrAg-positive, but have no features of central nervous system (CNS) disease, will be treated with high-dose fluconazole. Those with symptoms of CNS disease will be treated according to national guidelines. Survival, retention in care, and other clinical outcomes will be documented for patients who test CrAg-positive and are treated with fluconazole and those who test CrAg-negative. Data from those tested at participating labs but not eligible for enrollment in the longitudinal study will contribute to the estimation of the prevalence of CrAg.

Phase 2: From April 2017 to September 2017, a cost and cost-effectiveness analysis of CrAg screening will be conducted, a routine screening will be continued at existing sites and expanded to additional sites (preferentially to hospitals affiliated with Phase 1 OPCs and to other OPCs whose CD4 testing is conducted at laboratories already conducting CrAg screening as part of Phase 1). CrAg tests will also be made available to screen all patients with CD4≤100 cells/μL including those who are treatment-experienced. The test will also be made available for use among symptomatic patients for diagnostic purposes, including cerebral spinal fluid (CSF) and blood testing. Investigators will monitor prevalence at each testing site, but screened patients will not be enrolled in longitudinal follow-up. Phase 2 will last for at least 6 months based on the availability of funding and fluconazole for those who screen CrAg positive and the availability/stability of CD4 testing.

[Note that follow up of patients enrolled in Phase 1 will continue during this time period, but is considered to be part of Phase 1 rather than Phase 2. Also, sites included in Phase 2 may change over time as a result of the instability of CD4 testing (e.g., if participating laboratories stop conducting CD4 testing, those sites might no longer be included; if participating laboratories begin CD4 testing for other sites, those sites might be included).]


Study Type : Observational
Actual Enrollment : 1184 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vietnam Cryptococcal Retention in Care Study (CRICS) - Version 2.1
Actual Study Start Date : August 14, 2015
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Fluconazole

Group/Cohort Intervention/treatment
CrAg(+) and CM(-)
(1) Patients with CrAg positive without meningitis results will receive preemptive high-dose fluconazole to prevent developing meningitis.
Other: Preemptive high-dose Fluconazole
Patients with advanced HIV diseases are screened for Cryptococcal Antigen using LFA CrAg tests. Then patients with CrAg positivity and without meningitis are given preemptive high-dose fluconazole to prevent the development of cryptococcal meningitis, which is one of the leading cause of death among immunocompromized patients.
Other Name: Preemptive Fluconazole

CrAg(+) and CM(+)
(2) Patients with CrAg positive and meningitis results will receive standard treatment for cryptococcal meningitis, following national guidelines.
Other: Preemptive high-dose Fluconazole
Patients with advanced HIV diseases are screened for Cryptococcal Antigen using LFA CrAg tests. Then patients with CrAg positivity and without meningitis are given preemptive high-dose fluconazole to prevent the development of cryptococcal meningitis, which is one of the leading cause of death among immunocompromized patients.
Other Name: Preemptive Fluconazole

CrAg(-)
(3) Patients with CrAg negative results will be managed as other HIV infected patients with the standard of care, following national guidelines.
Other: Preemptive high-dose Fluconazole
Patients with advanced HIV diseases are screened for Cryptococcal Antigen using LFA CrAg tests. Then patients with CrAg positivity and without meningitis are given preemptive high-dose fluconazole to prevent the development of cryptococcal meningitis, which is one of the leading cause of death among immunocompromized patients.
Other Name: Preemptive Fluconazole




Primary Outcome Measures :
  1. Proportion of HIV-infected adults who have CD4 count ≤ 100 cells/μL [ Time Frame: August 2015 to March 2017 ]
    The number of HIV-infected adults with CD4 count ≤ 100 cells/μL divided by the total number of HIV-infected patients.

  2. Prevalence of CrAg-positivity among HIV-infected patients with CD4 ≤100 cells/μL [ Time Frame: August 2015 to March 2017 ]
    The number of CrAg-positivity divided by the number HIV-infected patients with CD4 ≤100 cells/μL

  3. Clinical outcomes including common causes of mortality for people living with HIV (PLHIV) with CD4 ≤ 100 cells/μL who are enrolled in a programmatic rollout of screening for CrAg [ Time Frame: August 2015 to March 2017 ]
    Clinical outcomes include HIV-related hospitalization, causes of death, new AIDS defining opportunistic infections at 6 and 12 month.

  4. Twelve (12) month all-causes and cryptococcal meningitis (CM)-related mortality among patients who screen CrAg-positive and CrAg-negative [ Time Frame: August 2015 to March 2017 ]

    The 12-month mortality among two groups of HIV-infected patients with CD4 ≤ 100 cells/μL who are enrolled in care and treatment:

    • Those who are CrAg-positive and are treated with high-dose fluconazole;
    • Those who are CrAg-negative.


Secondary Outcome Measures :
  1. Twelve (12) month retention among patients who screen CrAg-positive and CrAg-negative [ Time Frame: August 2015 to March 2017 ]
    The 12-month retention in care among two groups of HIV-infected patients with CD4 ≤ 100 cells/μL who are newly enrolled in care and treatment.

  2. Challenges associated with implementation of routine plasma CrAg screening in clinics providing HIV care [ Time Frame: August 2015 to March 2018 ]
    The challenges associated with implementation may include lost to follow up, incomplete documentation, and poor retention in care.

  3. Lessons learned with participating sites [ Time Frame: August 2015 to March 2018 ]
    This will be delivered at reflection and transition workshops with participating sites.

  4. Total costs and unit cost per person screened, per CrAg+ treated by site, lab facility type, and cost component. [ Time Frame: August 2015 to March 2017 ]
    The costs of implementing CrAg screening based on data to be collected at 22 participating clinics participating in Phase 1 and provider costs associated with CM treatment.

  5. Incremental cost-effectiveness ratio (cost per CM death averted and cost per quality adjusted life year (QALY)) [ Time Frame: August 2015 to March 2017 ]
    The incremental cost-effectiveness analysis of CrAg screening compared with a standard of care (no CrAg screening, and treatment for symptomatic CM only).

  6. Total cost savings and amount of financial resources required to implement CrAg screening [ Time Frame: August 2015 to March 2017 ]
    Potential cost savings from implementing CrAg screening and financial resources required to implement CrAg screening under different scale-up scenarios and for national rollout

  7. Proportion of stored samples that test positive for TmAg [ Time Frame: August 2015 to March 2017 ]
    The prevalence of Talaromyces marneffei antigenemia (TmAg) in stored CRICS samples using the Mannose phosphate isomerase 1 (MP1) enzyme-linked immunosorbent assay (ELISA)

  8. Six (6) and twelve (12) month all-causes and Talaromyces marneffei-related mortality among patients who screen TmAg-positive and TmAg-negative [ Time Frame: August 2015 to March 2017 ]
    The impact of TmAg positivity on mortality


Biospecimen Retention:   Samples With DNA
Whole blood samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced HIV infection (CD4<100 cells/microliters) who are eligible to inclusion and exclusion criteria are recruited and followed up into the study.
Criteria

Inclusion Criteria:

  • Aged ≥ 18 years (having passed 18th birthday using Western calendar)
  • Confirmed HIV infection using National Testing Algorithm
  • CD4 ≤100 cells/μL
  • Able to provide written informed consent
  • Enrolled at and plan to receive ongoing outpatient care at one of the selected study OPCs

Exclusion Criteria:

  • History of prior CM
  • Receipt of systemic antifungal medication for more than 4 consecutive weeks within the past 6 months
  • Receipt of ART for more than 4 consecutive weeks within the past year
  • For CrAg-positive patients only: Known to be currently pregnant or planning to become pregnant during the study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267407


Locations
Vietnam
National Hospital for Tropical Diseases
Hanoi, Vietnam, 100000
Sponsors and Collaborators
National Hospital for Tropical Diseases, Hanoi, Vietnam
Centers for Disease Control and Prevention
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Investigators
Principal Investigator: Kinh V Nguyen, MD National Hospital for Tropical Diseases, Hanoi, Vietnam
  Study Documents (Full-Text)

Documents provided by Vu Quoc Dat, National Hospital for Tropical Diseases, Hanoi, Vietnam:
Study Protocol  [PDF] January 7, 2017
Informed Consent Form  [PDF] January 7, 2017


Responsible Party: Vu Quoc Dat, Lead Coordinator, National Hospital for Tropical Diseases, Hanoi, Vietnam
ClinicalTrials.gov Identifier: NCT03267407     History of Changes
Other Study ID Numbers: 5U01GH000758-03 ( U.S. NIH Grant/Contract )
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Please contact principal investigators for any inquiries.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cryptococcosis
Mycoses
Mycosis Fungoides
Meningitis
Opportunistic Infections
Meningitis, Cryptococcal
HIV Infections
Acquired Immunodeficiency Syndrome
AIDS-Related Opportunistic Infections
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Central Nervous System Diseases
Nervous System Diseases
Infection
Virus Diseases
Parasitic Diseases
Meningitis, Fungal
Central Nervous System Fungal Infections
Central Nervous System Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections