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Trial record 13 of 53 for:    "Cryptococcosis"

Vietnam Cryptococcal Retention in Care Study Version 1.0 (CRICS)

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ClinicalTrials.gov Identifier: NCT02334670
Recruitment Status : Active, not recruiting
First Posted : January 8, 2015
Last Update Posted : September 13, 2017
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
National Hospital for Tropical Diseases, Hanoi, Vietnam

Brief Summary:
It is hypothesized that implementing plasma CrAg screening in clinics providing routine HIV care will enable identification of Vietnamese adult patients with advanced HIV (CD4 ≤100 cells/μL) who have early cryptococcal disease, enable prompt preemptive treatment with high-dose fluconazole, and improve survival.

Condition or disease Intervention/treatment
Meningitis, Cryptococcal Central Nervous System Fungal Infections Central Nervous System Infections Meningitis, Fungal Drug: Fluconazole

Detailed Description:
This is multicenter prospective cohort evaluation of the implementation of a cryptococcal antigen (CrAg) screening program in Vietnam. 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) and followed up for 12 months with clinical assessments and the collection of routine and supplemental survey data. 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.

Study Type : Observational
Estimated Enrollment : 2612 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a Public Health Strategy to Improve Survival of HIV Infected Patients
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(+)
Patients with symptoms of CNS disease will be treated according to Vietnam national guidelines for HIV/AIDS management.
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.

CrAg(+) and CM(-)
Patients with CrAg(+) and without CM symptoms will be treated with high-dose fluconazole. 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.
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.

CrAg negative
Patients with CrAg negative results will be managed as other HIV positive patients according to the national guidelines
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.




Primary Outcome Measures :
  1. Six (6) and (12) month all-cause and CM-related mortality among patients who screen CrAg-positive and CrAg-negative [ Time Frame: Up to 12 months after recruitment ]
  2. Proportion of all patients tested for plasma CrAg who have positive results [ Time Frame: Up to 12 months after recruitment ]

Secondary Outcome Measures :
  1. Percent of patients with HIV-related hospitalizations at 6 and 12 months [ Time Frame: 12 months after recruitment ]
  2. Percent of patients with new AIDS-defining OIs/conditions at 6 and 12 months [ Time Frame: 12 months after recruitment ]
  3. Causes of death [ Time Frame: 12 months after recruitment ]
  4. Six (6) and (12) month retention among patients who screen CrAg-positive and CrAg-negative [ Time Frame: 12 months after recruitment ]
  5. Percentage of patients with CD4≤ 100 cells/μL who are lost to follow-up or have incomplete documentation [ Time Frame: 12 months after recruitment ]
  6. % of patients with no documented clinic visit 30, 60, and 90 days after date of the scheduled clinic appointment [ Time Frame: 12 months after recruitment ]

Biospecimen Retention:   Samples With DNA
Complete 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
Newly registering and ART-naive patients with advanced HIV infection
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

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): NCT02334670


Locations
Vietnam
National Hospital for Tropical Diseases
Hanoi, Vietnam, 00000
Sponsors and Collaborators
National Hospital for Tropical Diseases, Hanoi, Vietnam
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Nguyen Van Kinh, MD, PhD National Hospital for Tropical Diseases

Responsible Party: National Hospital for Tropical Diseases, Hanoi, Vietnam
ClinicalTrials.gov Identifier: NCT02334670     History of Changes
Other Study ID Numbers: 1U01GH000758 ( U.S. NIH Grant/Contract )
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Please contact PI for any enquiries

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

Keywords provided by National Hospital for Tropical Diseases, Hanoi, Vietnam:
cryptococcal meningitis
HIV
AIDS
Fluconazole

Additional relevant MeSH terms:
Cryptococcosis
Infection
Communicable Diseases
Meningitis
Mycoses
Central Nervous System Infections
Meningitis, Cryptococcal
Central Nervous System Fungal Infections
Meningitis, Fungal
Central Nervous System Diseases
Nervous System Diseases
Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors