NCT02334670

Vietnam Cryptococcal Retention in Care Study Version 1.0

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,612 (estimated)
• Sponsor: National Hospital for Tropical Diseases, Hanoi, Vietnam · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Meningitis, Cryptococcal
• Central Nervous System Fungal Infections
• Central Nervous System Infections
• Meningitis, Fungal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-08-14
• Primary completion: 2018-03-31
• Completion: 2018-03-31
• First posted: 2015-01-08
• Last updated: 2017-09-13

Locations

1 site across 1 country: Vietnam