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

NCT05685641 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2023-01-17

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Histoplasma Urine Antigen Lateral Flow Antigen test

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

DIAGNOSTIC_TEST

Cryptococcal Lateral Flow Antigen test

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

DIAGNOSTIC_TEST

Tuberculosis-lipoarabinomannan Lateral Flow Antigen test

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

Sponsors & Collaborators

  • National Institute of Cancerology

    collaborator OTHER_GOV

  • Hospital General Dr. Manuel Gea González

    collaborator OTHER_GOV

  • National Institute of Medical Sciences and Nutrition, Salvador Zubiran

    collaborator OTHER

  • National Institute of Respiratory Diseases, Mexico

    lead OTHER_GOV

Principal Investigators

  • Antonio Camiro Zúñiga, MD · Centro Medico ABC

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-03-30
Completion
2024-09-30
FDA Device
Yes

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05685641 on ClinicalTrials.gov