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ClinicalTrials.gov ID

NCT05685641

Lead Sponsor

National Institute of Respiratory Diseases, MexicoOTHER_GOV

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

211Estimated

Last Update Posted

Jan 17, 2023Actual

Start Date

Apr 1, 2023Estimated

Primary Completion Date

Mar 30, 2024Estimated

Completion Date

Sep 30, 2024Estimated

Official Title

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

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.

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

• Histoplasma Urine Antigen Lateral Flow Antigen test
• Cryptococcal Lateral Flow Antigen test
• Tuberculosis-lipoarabinomannan Lateral Flow Antigen test

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

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.

Primary Purpose

Diagnostic

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

National Institute of Respiratory Diseases, MexicoOTHER_GOV

Collaborators

National Institute of CancerologyOTHER_GOV

Hospital General Dr. Manuel Gea GonzálezOTHER_GOV

National Institute of Medical Sciences and Nutrition, Salvador ZubiranOTHER

alexitemaon@gmail.com55 5628 0400