Vietnam Cryptococcal Retention in Care Study Version 1.0

NCT02334670 | Unknown

• 1 other identifier: 1U01GH000758
• Study Type: observational
• Target: 2,612
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cryptococcal meningitis; HIV; AIDS; Fluconazole

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (3)

CrAg(+) and CM(+)

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

Drug: 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

CrAg negative

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

Drug: Fluconazole

Interventions

Fluconazole DRUG

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; CrAg(+) and CM(+); CrAg(+) and CM(-)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly registering and ART-naive patients with advanced HIV infection

You may qualify if:

• Aged ≥ 18 years
• Confirmed HIV infection using National Testing Algorithm
• CD4 ≤100 cells/μL
• Able to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• National Hospital for Tropical Diseases, Hanoi, Vietnam: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

National Hospital for Tropical Diseases

Hanoi, 00000, Vietnam

Location

Biospecimen

Retention: SAMPLES WITH DNA

Complete blood samples

MeSH Terms

Conditions

Meningitis, Cryptococcal; Central Nervous System Fungal Infections; Central Nervous System Infections; Meningitis, Fungal; Acquired Immunodeficiency Syndrome

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Cryptococcosis; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nguyen Van Kinh, MD, PhD

  National Hospital for Tropical Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 8, 2015
• Study Start: August 14, 2015
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: September 13, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)