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

Primary Purpose

Acquired Immunodeficiency Syndrome, Histoplasmosis AIDS, Tuberculosis Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Histoplasma Urine Antigen Lateral Flow Antigen test
Cryptococcal Lateral Flow Antigen test
Tuberculosis-lipoarabinomannan Lateral Flow Antigen test
Sponsored by
National Institute of Respiratory Diseases, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acquired Immunodeficiency Syndrome focused on measuring Rapid Diagnostic Tests, Point-of-Care Systems

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • General Hospital Dr. Manuel Gea Gonzalez
  • National Center of Nutrition and Medical Sciences
  • National Institute of Cancerology
  • National Institute of Respiratory Diseases

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

AIDS-related mortality at 30 days
If a patient has died due to AIDS-related causes
AIDS-related mortality at 90 days
If a patient has died due to AIDS-related causes
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 until antiretroviral treatment initiation
Days passed from a patient's HIV diagnosis until he is given antiretroviral treatment for the first time

Full Information

First Posted
December 21, 2022
Last Updated
January 12, 2023
Sponsor
National Institute of Respiratory Diseases, Mexico
Collaborators
National Institute of Cancerology, Hospital General Dr. Manuel Gea González, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT05685641
Brief Title
Point of Care Tests to Identify Opportunistic Infections in Advanced HIV Patients in Mexico City
Acronym
PREVALIOCDMX
Official Title
Implementation Protocol for Rapid Diagnostic Tests for Opportunistic Infections in Reference Centers in Mexico City
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Respiratory Diseases, Mexico
Collaborators
National Institute of Cancerology, Hospital General Dr. Manuel Gea González, National Institute of Medical Sciences and Nutrition, Salvador Zubiran

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Immunodeficiency Syndrome, Histoplasmosis AIDS, Tuberculosis Infection, Cryptococcal Meningitis
Keywords
Rapid Diagnostic Tests, Point-of-Care Systems

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
211 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
Histoplasma Urine Antigen Lateral Flow Antigen test
Intervention Description
Lateral Flow Antigen test for urine samples to detect Histoplasma capsulatum disseminated disease
Intervention Type
Diagnostic Test
Intervention Name(s)
Cryptococcal Lateral Flow Antigen test
Intervention Description
Lateral Flow Antigen test for serum or cerebrospinal fluid samples to detect Cryptococcus sp meningitis or disseminated disease
Intervention Type
Diagnostic Test
Intervention Name(s)
Tuberculosis-lipoarabinomannan Lateral Flow Antigen test
Intervention Description
Lateral Flow Antigen test for serum samples to detect Mycobacterium tuberculosus disease
Primary Outcome Measure Information:
Title
Time until opportunistic infection treatment initiation
Description
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
Secondary Outcome Measure Information:
Title
AIDS-related mortality at 30 days
Description
If a patient has died due to AIDS-related causes
Time Frame
30 days
Title
AIDS-related mortality at 90 days
Description
If a patient has died due to AIDS-related causes
Time Frame
90 days
Title
Monthly incidence of histoplasmosis, cryptococcosis and tuberculosis
Description
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
Title
Time until antiretroviral treatment initiation
Description
Days passed from a patient's HIV diagnosis until he is given antiretroviral treatment for the first time
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victor Ahumada Topete, MD
Phone
55 5487 1700
Email
victor.ahumada@uehi.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Camiro Zúñiga, MD
Organizational Affiliation
Centro Medico ABC
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital Dr. Manuel Gea Gonzalez
City
Mexico City
Country
Mexico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Patricia Rodríguez Zulueta, MD
Phone
55 4000 3000
Email
rozu76@gmail.com
Facility Name
National Center of Nutrition and Medical Sciences
City
Mexico City
Country
Mexico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Álvaro López Iñiguez, MD
Phone
55 5487 0900
Email
alvarolopez@revistamedicamd.com
Facility Name
National Institute of Cancerology
City
Mexico City
Country
Mexico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Martin Onraet, MD
Phone
55 5628 0400
Email
alexitemaon@gmail.com
Facility Name
National Institute of Respiratory Diseases
City
Mexico City
Country
Mexico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Ahumada Topete, MD
Phone
55 5487 1700
Email
victor.ahumada@uehi.mx

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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