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

NCT05685641 | Unknown FDA Device

• 1 other identifier: 181250
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Acquired Immunodeficiency Syndrome; Histoplasmosis AIDS; Tuberculosis Infection; Cryptococcal Meningitis

Keywords

Rapid Diagnostic Tests; Point-of-Care Systems

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• AIDS-related mortality at 30 days

  30 days

• AIDS-related mortality at 90 days

  90 days

• Monthly incidence of histoplasmosis, cryptococcosis and tuberculosis

  Through study completion, an average of 1 year

• Time until antiretroviral treatment initiation

  30 days

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Interventions

Histoplasma Urine Antigen Lateral Flow Antigen test DIAGNOSTIC_TEST

Lateral Flow Antigen test for urine samples to detect Histoplasma capsulatum disseminated disease

Intervention group

Cryptococcal Lateral Flow Antigen test DIAGNOSTIC_TEST

Lateral Flow Antigen test for serum or cerebrospinal fluid samples to detect Cryptococcus sp meningitis or disseminated disease

Intervention group

Tuberculosis-lipoarabinomannan Lateral Flow Antigen test DIAGNOSTIC_TEST

Lateral Flow Antigen test for serum samples to detect Mycobacterium tuberculosus disease

Intervention group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive ELISA test or positive viral load for HIV.
• Patients with suspected or confirmed advanced HIV disease defined as follows:
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Respiratory Diseases, Mexico: lead
• National Institute of Cancerology: collaborator
• Hospital General Dr. Manuel Gea González: collaborator
• National Institute of Medical Sciences and Nutrition, Salvador Zubiran: collaborator

Study Sites (4)

General Hospital Dr. Manuel Gea Gonzalez

Mexico City, Mexico

Location

National Center of Nutrition and Medical Sciences

Mexico City, Mexico

Location

National Institute of Cancerology

Mexico City, Mexico

Location

National Institute of Respiratory Diseases

Mexico City, Mexico

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Latent Tuberculosis; Meningitis, Cryptococcal

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; 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; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Latent Infection; Meningitis, Fungal; Central Nervous System Fungal Infections; Mycoses; Cryptococcosis; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Study Officials

• Antonio Camiro Zúñiga, MD

  Centro Medico ABC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Ahumada Topete, MD

CONTACT

55 5487 1700; victor.ahumada@uehi.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 17, 2023
• Study Start: April 1, 2023
• Primary Completion: March 30, 2024
• Study Completion: September 30, 2024
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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

Locations

ME (4)