Point of Care Tests to Identify Opportunistic Infections in Advanced HIV Patients in Mexico City

Acquired Immunodeficiency Syndrome Clinical Trial

— PREVALIOCDMX  

Official title:

Implementation Protocol for Rapid Diagnostic Tests for Opportunistic Infections in Reference Centers in Mexico City

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05685641
• Other study ID #: 181250
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2023
• Source: National Institute of Respiratory Diseases, Mexico
• Contact: Victor Ahumada Topete, MD
• Phone: 55 5487 1700
• Email: victor.ahumada[@]uehi.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 211
• Est. completion date: September 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Positive ELISA test or positive viral load for HIV.
• Patients with suspected or confirmed advanced HIV disease defined as follows:
• Confirmed: asymptomatic patients with CD4 count less than 200 cells/ml within 3 months of study inclusion or confirmed diagnosis of an AIDS-defining opportunistic illness within the last 3 months.
• Suspected: patients who, irrespective of CD4 count, present any symptoms suggestive of systemic infection that, at the discretion of the treating physicians, produce suspicion of an AIDS-defining opportunistic disease (e.g., fever, productive cough, diaphragmatic diapers, etc.). Fever, productive cough, nocturnal diaphoresis, altered mental status, headache, lymphadenopathy, dermatological lesions) or that meet criteria for HIV wasting syndrome (loss of 10% of baseline weight plus the presence of chronic diarrhea or chronic weakness and an episode of fever in the last 30 days).
• Patients without effective antiretroviral therapy defined as not having received antiretroviral treatment in the last 3 months or in virologic failure (2 consecutive viral loads with more than 1000 copies/ml).

Exclusion Criteria:

• Patients with a viral load of less than 1000 copies/ml.
• Patients presenting for care having started treatment for systemic mycoses (amphotericin B or azoles) and tuberculosis.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• Cryptococcal Meningitis
• Histoplasmosis
• HIV Infections
• Immunologic Deficiency Syndromes
• Infections
• Latent Tuberculosis
• Meningitis
• Meningitis, Cryptococcal
• Opportunistic Infections
• Tuberculosis
• Tuberculosis Infection

Intervention

Diagnostic Test:
• Histoplasma Urine Antigen Lateral Flow Antigen test
Lateral Flow Antigen test for urine samples to detect Histoplasma capsulatum disseminated disease
• Cryptococcal Lateral Flow Antigen test
Lateral Flow Antigen test for serum or cerebrospinal fluid samples to detect Cryptococcus sp meningitis or disseminated disease
• Tuberculosis-lipoarabinomannan Lateral Flow Antigen test
Lateral Flow Antigen test for serum samples to detect Mycobacterium tuberculosus disease

Locations

Country	Name	City	State
Mexico	General Hospital Dr. Manuel Gea Gonzalez	Mexico City
Mexico	National Center of Nutrition and Medical Sciences	Mexico City
Mexico	National Institute of Cancerology	Mexico City
Mexico	National Institute of Respiratory Diseases	Mexico City

Sponsors (4)

Lead Sponsor	Collaborator
National Institute of Respiratory Diseases, Mexico	Hospital General Dr. Manuel Gea González, National Institute of Cancerology, National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Secondary	AIDS-related mortality at 30 days	If a patient has died due to AIDS-related causes	30 days
Secondary	AIDS-related mortality at 90 days	If a patient has died due to AIDS-related causes	90 days
Secondary	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	Through study completion, an average of 1 year
Secondary	Time until antiretroviral treatment initiation	Days passed from a patient's HIV diagnosis until he is given antiretroviral treatment for the first time	30 days