HIV Primary InfectionFUJILAMNCT05036694
Diagnostic Performance of a Novel Lipoarabinomannan.
A study testing FUJILAM KIT in people with HIV Primary Infection, run by Médecins Sans Frontières, Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Primary Infection
- What is being tested?
- FUJILAM KIT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 15 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
HELENA DR Coordinating Principal Investigator, PhD contact
About this study
Official title: Diagnostic Performance of a Novel Lipoarabinomannan Test (FujiLAM) to Detect Tuberculosis in HIV-positive Patients in Kenya
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).
Read the detailed description
The study aims to assess the performance of a new test called the Fujifilm SILVAMP TB LAM or simply the Fuji-LAM test. The Fuji-LAM test is a test that can be done on urine to look for specific proteins that are produced by the bacteria that causes tuberculosis. This test offers an advantage over the tests that are based on phlegm because most patients can produce urine for testing even when they are very sick. Additionally, this test does not require a complex laboratory set up and it can therefore be used by health workers as they interact with the patient. This study will also look at how the new test compares with an existing test AlereLAM - that is based on similar technology. Initial laboratory-based studies conducted on frozen urine samples show that the new test has better performance than the existing test. This study is different from the first studies because it is being conducted in real life settings rather than in a laboratory.
The study will be conducted at the Homa Bay County Hospital in Kenya. Individuals living with HIV with and without signs and symptoms of TB will be invited to take part. Individuals who agree to participate will be seen by the health workers in the study and will provide samples for testing using the FujiLAM test and other standard tests used to investigate individuals for suspected tuberculosis.
Investigators are also conducting similar studies in other African countries including Uganda, Mozambique and South Africa. This will enable investigators to assess the performance of the test in diverse settings.
- Conditions
- HIV Primary Infection
- Being tested
- FUJILAM KIT
- Keywords
- TUBERCULOSIS IN HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FUJILAM KITDevice
Urine based test to detect LAM
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: FUJILAM KIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (1)
To assess the sensitivity of FujiLAM at different levels of CD4 count.
- Proportion of patients with a positive FujiLAM result among patients with probable TB or microbiologically confirmed TB in ambulatory HIV-positive patients with signs and symptoms of TB (Group 1) and in ambulatory HIV-positive patients with advanced HIV disease and no signs and symptoms of TB (Group 2).
- Proportion of patients with a positive FujiLAM result among patients with microbiologically confirmed TB and among patients with probable TB or microbiologically confirmed TB by level CD4.
- Proportion of patients with a positive AlereLAM among patients with microbiologically confirmed
- TB and among patients with probable TB or microbiologically confirmed TB by level of CD4.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study startSep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Primary InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- GROUP 1\_ TB SYMPTOMS GROUP2\_ ADVANCED HIV WITH NO TB SYMPTOMS
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Médecins Sans Frontières, Kenya
- Sponsor type
- University, hospital or other
- Collaborators
- Epicentre
- Responsible party
- Sponsor
- Investigators
- HELENA DR Coordinating Principal Investigator, PhD, Principal investigator, MEDECIN SAN FRONTIERES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036694
- Sponsor's protocol ID
- ANRS12429
- Acronym
- FUJILAM
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of a Novel Lipoarabinomannan Test (FujiLAM) to Detect Tuberculosis in HIV-positive Patients in Kenya
- ClinicalTrials.gov ID
- NCT05036694
- Acronym / sponsor ID
- FUJILAM / ANRS12429
- Conditions
- HIV Primary Infection
- Keywords
- TUBERCULOSIS IN HIV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Médecins Sans Frontières, KenyaUniversity, hospital or other
- Collaborators
- Epicentre
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study aims to assess the performance of a new test called the Fujifilm SILVAMP TB LAM or simply the Fuji-LAM test. The Fuji-LAM test is a test that can be done on urine to look for specific proteins that are produced by the bacteria that causes tuberculosis. This test offers an advantage over the tests that are based on phlegm because most patients can produce urine for testing even when they are very sick. Additionally, this test does not require a complex laboratory set up and it can therefore be used by health workers as they interact with the patient. This study will also look at how the new test compares with an existing test AlereLAM - that is based on similar technology. Initial laboratory-based studies conducted on frozen urine samples show that the new test has better performance than the existing test. This study is different from the first studies because it is being conducted in real life settings rather than in a laboratory.
The study will be conducted at the Homa Bay County Hospital in Kenya. Individuals living with HIV with and without signs and symptoms of TB will be invited to take part. Individuals who agree to participate will be seen by the health workers in the study and will provide samples for testing using the FujiLAM test and other standard tests used to investigate individuals for suspected tuberculosis.
Investigators are also conducting similar studies in other African countries including Uganda, Mozambique and South Africa. This will enable investigators to assess the performance of the test in diverse settings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- GROUP 1_ TB SYMPTOMS GROUP2_ ADVANCED HIV WITH NO TB SYMPTOMS
| Arm | Type | Receives |
|---|---|---|
| Ambulatory HIV positive patients | Other | Device: FUJILAM KITAmbulatory HIV positive patients with signs and symptoms of TB, and Ambulatory HIV positive patients with advanced disease and CD4 less than 200 cell. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 15 years of age or older
- HIV-positive Group 1: At least one symptom of TB
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FUJILAM KITUrine based test to detect LAM | Device | Ambulatory HIV positive patients |
Primary outcome
To investigate the diagnostic performance of FujiLAM in ambulatory HIV positive patients.
Time frame: 12 months
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).
1 secondary outcome
To assess the sensitivity of FujiLAM at different levels of CD4 count.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
Related trials for HIV Primary Infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Recruiting
HIV/HBV/HCV Triple Screening in Primary Care
HIV, HBV (Hepatitis B Virus)
Recruiting
Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
Drug Resistant Tuberculosis
RecruitingObservational study
Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer
HIV, Kaposi's Sarcoma
Recruiting
Intervention to Enhance PrEP Persistence
HIV Prevention, HIV Infection Primary
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HELENA DR Coordinating Principal Investigator, PhD contact
HELENA DR Coordinating Principal Investigator, PhD principal investigator
MEDECIN SAN FRONTIERES
Questions about this trial
What is this clinical trial studying?
A study testing FUJILAM KIT in people with HIV Primary Infection, run by Médecins Sans Frontières, Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HELENA DR Coordinating Principal Investigator, PhD (+32493837895, Helena.HUERGA@epicentre.msf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the diagnostic performance of FujiLAM in ambulatory HIV positive patients. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.