Vietnam Cryptococcal Retention in Care Study Version 1.0

Meningitis, Cryptococcal Clinical Trial

— CRICS  

Official title:

Evaluation of a Public Health Strategy to Improve Survival of HIV Infected Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02334670
• Other study ID #: 1U01GH000758
• Status: Active, not recruiting
• Phase: N/A
• First received: January 5, 2015
• Last updated: September 12, 2017
• Start date: August 14, 2015
• Est. completion date: March 31, 2018

Study information

• Verified date: September 2017
• Source: National Hospital for Tropical Diseases, Hanoi, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2612
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Fungal Infections
• Central Nervous System Infections
• Communicable Diseases
• Infection
• Meningitis
• Meningitis, Cryptococcal
• Meningitis, Fungal
• Mycoses

Intervention

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.

Locations

Country	Name	City	State
Vietnam	National Hospital for Tropical Diseases	Hanoi

Sponsors (2)

Lead Sponsor	Collaborator
National Hospital for Tropical Diseases, Hanoi, Vietnam	Centers for Disease Control and Prevention

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six (6) and (12) month all-cause and CM-related mortality among patients who screen CrAg-positive and CrAg-negative		Up to 12 months after recruitment
Primary	Proportion of all patients tested for plasma CrAg who have positive results		Up to 12 months after recruitment
Secondary	Percent of patients with HIV-related hospitalizations at 6 and 12 months		12 months after recruitment
Secondary	Percent of patients with new AIDS-defining OIs/conditions at 6 and 12 months		12 months after recruitment
Secondary	Causes of death		12 months after recruitment
Secondary	Six (6) and (12) month retention among patients who screen CrAg-positive and CrAg-negative		12 months after recruitment
Secondary	Percentage of patients with CD4= 100 cells/µL who are lost to follow-up or have incomplete documentation		12 months after recruitment
Secondary	% of patients with no documented clinic visit 30, 60, and 90 days after date of the scheduled clinic appointment		12 months after recruitment