Diagnostic Performance of a Novel Lipoarabinomannan.

NCT05036694 | Unknown

• 1 other identifier: ANRS12429
• Study Type: interventional
• Target: 550
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Fujifilm SILVAMP TB LAM (FujiLAM; Fujifilm, Tokyo, Japan) is a novel (not commercialized) urine based point-of-care assay to diagnose TB in HIV-positive patients. A first study using urine frozen samples has reported a higher sensitivity of this test over the currently commercialised Alere Determine TB LAM Ag assay (AlereLAM).

Conditions

HIV Primary Infection

Keywords

TUBERCULOSIS IN HIV

Outcome Measures

Primary Outcomes (1)

• To investigate the diagnostic performance of FujiLAM in ambulatory HIV positive patients.

  Proportion of patients with a positive FujiLAM result among patients with microbiologically confirmed TB in ambulatory HIV-positive patients with signs and symptoms of TB (Group 1) and Diagnostic performance of FujiLAM test to detect tuberculosis in HIV-positive patients in Kenya - Protocol v2.3 14 in ambulatory HIV-positive patients with advanced HIV disease and no signs and symptoms of TB (Group 2).

  12 months

Secondary Outcomes (1)

• To assess the sensitivity of FujiLAM at different levels of CD4 count.

  12 months

Study Arms (1)

Ambulatory HIV positive patients

OTHER

Ambulatory HIV positive patients with signs and symptoms of TB, and Ambulatory HIV positive patients with advanced disease and CD4 less than 200 cell.

Device: FUJILAM KIT

Interventions

FUJILAM KIT DEVICE

Urine based test to detect LAM

Ambulatory HIV positive patients

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• HIV-positive Group 1: At least one symptom of TB
• Group 2:
• Advanced HIV disease (CD4 count less than 200cell/µl or clinical stage III/IV)
• No signs and symptoms of TB
• Signature of the informed consent

You may not qualify if:

• Intake of anti-tuberculosis drugs for more than 5 days in the month prior to the consultation except preventive TB treatment.
• Decline to sign informed consent.

Sponsors & Collaborators

• Médecins Sans Frontières, Kenya: lead
• Epicentre: collaborator

Study Officials

• HELENA DR Coordinating Principal Investigator, PhD

  MEDECIN SAN FRONTIERES

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HELENA DR Coordinating Principal Investigator, PhD

CONTACT

+32493837895; Helena.HUERGA@epicentre.msf.org

STEPHEN DR Site Principal Investigator, MPH

CONTACT

+254720284862; wansiste07@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: We are not blinding the two arms
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: GROUP 1\_ TB SYMPTOMS GROUP2\_ ADVANCED HIV WITH NO TB SYMPTOMS

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: September 8, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 8, 2021

Record last verified: 2021-07