An interventional study of Histoplasma Urine Antigen Lateral Flow Antigen test and Cryptococcal Lateral Flow Antigen test in Acquired Immunodeficiency Syndrome, Histoplasmosis AIDS and Tuberculosis Infection, sponsored by National Institute of Respiratory Diseases, Mexico. Status unknown at 4 sites in Mexico. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-01-17.
Sponsored by National Institute of Respiratory Diseases, Mexico · Not applicable, Interventional, and Diagnostic
In Mexico City, the main cause of mortality among people living with HIV (PLHIV) continues to be opportunistic infections (OIs). Early detection of OIs allows their timely treatment and improves their prognosis. The use of rapid diagnostic tests (RDT) based on antigens of the most frequent causative agents of OIs allows adequate screening of these patients and facilitates decision making at the point of care. Unfortunately, these studies are not widely available in the different PLHIV care centers in the CDMX. We will conduct an open-label, non-inferiority uncontrolled clinical trial to investigate the diagnostic performance of urinary lipoarabinomannan, urinary Histoplasma antigen and serum Cryptococcus antigen in patients presenting for care with advanced HIV in CDMX, supported by rapid cluster of differentiation 4 (CD4) testing with lateral flow technology. Four referral hospitals will participate over 12 months. All patients with diagnosed HIV disease and suspected advanced disease presenting for care at participating centers will be included in the study. An inventory of approximately 1000 RDT will be obtained and distributed among the participating sites. A study coordinator will be hired and will visit each site once a week to collect the study variables and follow up on the included patients. The primary outcome of the study will be the percentage of patients with advanced disease who present with diagnoses made by RDT compared to historical controls of patients diagnosed with OI in 2022 at participating centers by conventional methods. Secondary outcomes will be time to initiation of antiretroviral therapy (ART), time to initiation of OI treatment, and 30-day mortality after HIV diagnosis.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's planned enrollment of 211 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →National Institute of Respiratory Diseases, Mexico is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
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Patients with suspected or confirmed advanced HIV disease defined as follows:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All enrolled patients will be included in this arm of the study, patients will be administered all rapid diagnostic tests as part of their diagnostic work-up (this will constitute the main intervention of the study)
Diagnostic Test: Histoplasma Urine Antigen Lateral Flow Antigen test · Diagnostic Test: Cryptococcal Lateral Flow Antigen test · Diagnostic Test: Tuberculosis-lipoarabinomannan Lateral Flow Antigen test
Lateral Flow Antigen test for urine samples to detect Histoplasma capsulatum disseminated disease
Lateral Flow Antigen test for serum or cerebrospinal fluid samples to detect Cryptococcus sp meningitis or disseminated disease
Lateral Flow Antigen test for serum samples to detect Mycobacterium tuberculosus disease
Time until opportunistic infection treatment initiation
Amount of time in days from the diagnosis of the opportunistic infection until the initiation of the specific treatment for the detected infection
Time frame: 30 days
AIDS-related mortality at 30 days
If a patient has died due to AIDS-related causes
Time frame: 30 days
AIDS-related mortality at 90 days
If a patient has died due to AIDS-related causes
Time frame: 90 days
Monthly incidence of histoplasmosis, cryptococcosis and tuberculosis
The amount of diagnosed cases of histoplasmosis, cryptococcosis and tuberculosis per amount of advanced HIV-patients seen every month in the study sites
Time frame: Through study completion, an average of 1 year
Time until antiretroviral treatment initiation
Days passed from a patient's HIV diagnosis until he is given antiretroviral treatment for the first time
Time frame: 30 days
Plan to share: Yes — Deidentified data will be uploaded to a public database sharing website
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be made publicly available after publishing of the study in a peer reviewed journal
Access criteria: Data will be made available upon request
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
National Institute of Respiratory Diseases, Mexico