CRICS: Vietnam Cryptococcal Retention in Care Study Version 1.0
Study Details
Study Description
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 | Phase |
|---|---|---|
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 Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Percent of patients with HIV-related hospitalizations at 6 and 12 months [12 months after recruitment]
- Percent of patients with new AIDS-defining OIs/conditions at 6 and 12 months [12 months after recruitment]
- 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]
- Percentage of patients with CD4≤ 100 cells/μL who are lost to follow-up or have incomplete documentation [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]
Eligibility Criteria
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:
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History of prior CM
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Receipt of systemic antifungal medication for more than 4 consecutive weeks within the past 6 months
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1U01GH000758