Central Nervous System Fungal Infections, Central Nervous System Infections, Meningitis, Cryptococcal, Meningitis, Fungal
Conditions
Keywords
cryptococcal meningitis, HIV, AIDS, Fluconazole
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.
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.
Interventions
DRUGFluconazole
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.
Sponsors
Centers for Disease Control and Prevention
National Hospital for Tropical Diseases, Hanoi, Vietnam
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Proportion of all patients tested for plasma CrAg who have positive results | Up to 12 months after recruitment |
Secondary
| Measure | Time frame |
|---|---|
| Causes of death | 12 months after recruitment |
| Six (6) and (12) month retention among patients who screen CrAg-positive and CrAg-negative | 12 months after recruitment |
| Percent of patients with HIV-related hospitalizations at 6 and 12 months | 12 months after recruitment |
| % of patients with no documented clinic visit 30, 60, and 90 days after date of the scheduled clinic appointment | 12 months after recruitment |
| Percentage of patients with CD4≤ 100 cells/μL who are lost to follow-up or have incomplete documentation | 12 months after recruitment |
| Percent of patients with new AIDS-defining OIs/conditions at 6 and 12 months | 12 months after recruitment |
Countries
Vietnam
Outcome results
None listed