Acquired Immunodeficiency SyndromePREVALIOCDMXNCT05685641
Point of Care Tests to Identify Opportunistic Infections in Advanced HIV Patients in Mexico City
A study testing Histoplasma Urine Antigen Lateral Flow Antigen test, Cryptococcal Lateral Flow Antigen test and Tuberculosis-lipoarabinomannan Lateral Flow Antigen test in people with Acquired Immunodeficiency Syndrome and Histoplasmosis AIDS, run by National Institute of Respiratory Diseases, Mexico at 4 sites in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acquired Immunodeficiency Syndrome, Histoplasmosis AIDS, Tuberculosis Infection
- What is being tested?
- Histoplasma Urine Antigen Lateral Flow Antigen test, Cryptococcal Lateral Flow Antigen test and Tuberculosis-lipoarabinomannan Lateral Flow Antigen test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 4 sitesMexico
- Study dates
- 1 Apr 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Mexico4 sites
General Hospital Dr. Manuel Gea Gonzalez
Mexico City
Ana Patricia Rodríguez Zulueta, MD, 55 4000 3000, rozu76@gmail.com
National Center of Nutrition and Medical Sciences
Mexico City
Álvaro López Iñiguez, MD, 55 5487 0900, alvarolopez@revistamedicamd.com
National Institute of Cancerology
Mexico City
Alexandra Martin Onraet, MD, 55 5628 0400, alexitemaon@gmail.com
National Institute of Respiratory Diseases
Mexico City
Victor Ahumada Topete, MD, 55 5487 1700, victor.ahumada@uehi.mx
About this study
Official title: 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.
- Conditions
- Acquired Immunodeficiency Syndrome, Histoplasmosis AIDS, Tuberculosis Infection, Cryptococcal Meningitis
- Being tested
- Histoplasma Urine Antigen Lateral Flow Antigen test, Cryptococcal Lateral Flow Antigen test, Tuberculosis-lipoarabinomannan Lateral Flow Antigen test
- Keywords
- Rapid Diagnostic Tests, Point-of-Care Systems
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Latent Tuberculosis, Meningitis, Cryptococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histoplasma Urine Antigen Lateral Flow Antigen testDiagnostic test
Lateral Flow Antigen test for urine samples to detect Histoplasma capsulatum disseminated disease
Cryptococcal Lateral Flow Antigen testDiagnostic test
Lateral Flow Antigen test for serum or cerebrospinal fluid samples to detect Cryptococcus sp meningitis or disseminated disease
Tuberculosis-lipoarabinomannan Lateral Flow Antigen testDiagnostic test
Lateral Flow Antigen test for serum samples to detect Mycobacterium tuberculosus disease
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Histoplasma Urine Antigen Lateral Flow Antigen test; Diagnostic Test: Cryptococcal Lateral Flow Antigen test; Diagnostic Test: Tuberculosis-lipoarabinomannan Lateral Flow Antigen test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (4)
AIDS-related mortality at 30 days
If a patient has died due to AIDS-related causes
Measured: 30 days
AIDS-related mortality at 90 days
If a patient has died due to AIDS-related causes
Measured: 90 days
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
Measured: Through study completion, an average of 1 year
Time until antiretroviral treatment initiation
Days passed from a patient's HIV diagnosis until he is given antiretroviral treatment for the first time
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Apr 2023 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 211 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Respiratory Diseases, Mexico
- Sponsor type
- Other government
- Collaborators
- National Institute of Cancerology, Hospital General Dr. Manuel Gea González, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Responsible party
- Sponsor
- Investigators
- Antonio Camiro Zúñiga, MD, Principal investigator, Centro Medico ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685641
- Sponsor's protocol ID
- 181250
- Acronym
- PREVALIOCDMX
- Status last verified
- Jan 2023
- First submitted
- 21 Dec 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified data will be uploaded to a public database sharing website
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Protocol for Rapid Diagnostic Tests for Opportunistic Infections in Reference Centers in Mexico City
- ClinicalTrials.gov ID
- NCT05685641
- Acronym / sponsor ID
- PREVALIOCDMX / 181250
- Conditions
- Acquired Immunodeficiency Syndrome, Histoplasmosis AIDS, Tuberculosis Infection, Cryptococcal Meningitis
- Keywords
- Rapid Diagnostic Tests, Point-of-Care Systems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 211 participants (estimated)
- Lead sponsor
- National Institute of Respiratory Diseases, MexicoOther government
- Collaborators
- National Institute of Cancerology, Hospital General Dr. Manuel Gea González, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Diagnostic Test: Histoplasma Urine Antigen Lateral Flow Antigen test, Diagnostic Test: Cryptococcal Lateral Flow Antigen test, Diagnostic Test: Tuberculosis-lipoarabinomannan Lateral Flow Antigen testAll 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) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Positive ELISA test or positive viral load for HIV.
- Patients with suspected or confirmed advanced HIV disease defined as follows:
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Histoplasma Urine Antigen Lateral Flow Antigen testLateral Flow Antigen test for urine samples to detect Histoplasma capsulatum disseminated disease | Diagnostic test | Intervention group |
| Cryptococcal Lateral Flow Antigen testLateral Flow Antigen test for serum or cerebrospinal fluid samples to detect Cryptococcus sp meningitis or disseminated disease | Diagnostic test | Intervention group |
| Tuberculosis-lipoarabinomannan Lateral Flow Antigen testLateral Flow Antigen test for serum samples to detect Mycobacterium tuberculosus disease | Diagnostic test | Intervention group |
Primary outcome
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
4 secondary outcomes
AIDS-related mortality at 30 days
Time frame: 30 days
AIDS-related mortality at 90 days
Time frame: 90 days
Monthly incidence of histoplasmosis, cryptococcosis and tuberculosis
Time frame: Through study completion, an average of 1 year
Time until antiretroviral treatment initiation
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Individual participant dataSharing planned: Yes. Deidentified data will be uploaded to a public database sharing website
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Camiro Zúñiga, MD principal investigator
Centro Medico ABC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Histoplasma Urine Antigen Lateral Flow Antigen test, Cryptococcal Lateral Flow Antigen test and Tuberculosis-lipoarabinomannan Lateral Flow Antigen test in people with Acquired Immunodeficiency Syndrome and Histoplasmosis AIDS, run by National Institute of Respiratory Diseases, Mexico at 4 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victor Ahumada Topete, MD (55 5487 1700, victor.ahumada@uehi.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until opportunistic infection treatment initiation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.