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

January 12, 2023 updated by: National Institute of Respiratory Diseases, Mexico

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

211

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
      • Mexico City, Mexico
        • General Hospital Dr. Manuel Gea Gonzalez
        • Contact:
          • Ana Patricia Rodríguez Zulueta, MD
          • Phone Number: 55 4000 3000
          • Email: rozu76@gmail.com
      • Mexico City, Mexico
      • Mexico City, Mexico
        • National Institute of Cancerology
        • Contact:
      • Mexico City, Mexico
        • National Institute of Respiratory Diseases
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time until opportunistic infection treatment initiation
Time Frame: 30 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
AIDS-related mortality at 30 days
Time Frame: 30 days
If a patient has died due to AIDS-related causes
30 days
AIDS-related mortality at 90 days
Time Frame: 90 days
If a patient has died due to AIDS-related causes
90 days
Monthly incidence of histoplasmosis, cryptococcosis and tuberculosis
Time Frame: Through study completion, an average of 1 year
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
Time until antiretroviral treatment initiation
Time Frame: 30 days
Days passed from a patient's HIV diagnosis until he is given antiretroviral treatment for the first time
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Respiratory Diseases, Mexico

Collaborators

Hospital General Dr. Manuel Gea González
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
National Institute of Cancerology

Investigators

  • Principal Investigator: Antonio Camiro Zúñiga, MD, Centro Médico ABC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

March 30, 2024

Study Completion (Anticipated)

September 30, 2024

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Estimate)

January 16, 2023

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 181250

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Deidentified data will be uploaded to a public database sharing website

IPD Sharing Time Frame

Data will be made publicly available after publishing of the study in a peer reviewed journal

IPD Sharing Access Criteria

Data will be made available upon request

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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