Trial | NCT02334670  Report issue

Title

Vietnam Cryptococcal Retention in Care Study Version 1.0
Evaluation of a Public Health Strategy to Improve Survival of HIV Infected Patients

  • Phase

    N/A

  • Study Type

    Observational

  • Status

    Unknown status

  • Study Participants

    2612
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.
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 Started
Aug 14
2015
Primary Completion
Mar 31
2018
Anticipated
Study Completion
Mar 31
2018
Anticipated
Last Update
Sep 13
2017

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(+) None

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

CrAg(+) and CM(-) None

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.

CrAg negative None

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

Population

Newly registering and ART-naive patients with advanced HIV infection

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:

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
No Results Posted