Vietnam Cryptococcal Retention in Care Study (CRICS) Federal Financial Report

National Hospital for Tropical Diseases, Hanoi, Vietnam

Status and phase: Completed; Phase 1

Conditions: Cryptococcal Meningitis

Treatments: Other: Vietnam Cryptococcal Retention in Care Study (CRICS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02955862

3U01GH000758-02S1

Details and patient eligibility

About

CRICS financial report for the first budget year of the study

Full description

Vietnam Cryptococcal Retention in Care Study (CRICS) federal financial report for the first budget year of the study

Enrollment: 1,177 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,177 participants in 1 patient group

Assigned Interventions Antifungals Patients with symptoms

Other group

Description:

Patients with symptoms of CNS disease will be treated according to Vietnam national guidelines for HIV/AIDS management. For CrAg-positive patients, 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:

Other: Vietnam Cryptococcal Retention in Care Study (CRICS)