Vietnam Cryptococcal Retention in Care Study Version 1.0 (CRICS)

National Hospital for Tropical Diseases, Hanoi, Vietnam

Status: Unknown

Conditions: Meningitis, Cryptococcal; Central Nervous System Fungal Infections; Meningitis, Fungal; Central Nervous System Infections

Treatments: Drug: Fluconazole

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02334670

1U01GH000758

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,612 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,612 participants in 3 patient groups

CrAg(+) and CM(+)

Description:

Patients with symptoms of CNS disease will be treated according to Vietnam national guidelines for HIV/AIDS management.

Treatment:

Drug: Fluconazole

CrAg(+) and CM(-)

Description:

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.

Treatment:

Drug: Fluconazole

CrAg negative

Description:

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

Treatment:

Drug: Fluconazole