Clinical trial NCT05685641: Point of Care Tests to Identify Opportunistic Infections in Advanced HIV Patients in Mexico City
Official title: Implementation Protocol for Rapid Diagnostic Tests for Opportunistic Infections in Reference Centers in Mexico City
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acquired Immunodeficiency Syndrome
Histoplasmosis AIDS
Tuberculosis Infection
Cryptococcal Meningitis
Keywords: Rapid Diagnostic Tests
Point-of-Care Systems
Lead sponsor: National Institute of Respiratory Diseases, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: National Institute of Cancerology
name: Hospital General Dr. Manuel Gea González
name: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
First posted: 2023-01-17
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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 outcomes:
measure: Time until opportunistic infection treatment initiation
timeFrame: 30 days
Secondary outcomes:
measure: AIDS-related mortality at 30 days
timeFrame: 30 days
measure: AIDS-related mortality at 90 days
timeFrame: 90 days
measure: Monthly incidence of histoplasmosis, cryptococcosis and tuberculosis
timeFrame: Through study completion, an average of 1 year
measure: Time until antiretroviral treatment initiation
timeFrame: 30 days
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: General Hospital Dr. Manuel Gea Gonzalez
city: Mexico City
country: Mexico
facility: National Center of Nutrition and Medical Sciences
city: Mexico City
country: Mexico
facility: National Institute of Cancerology
city: Mexico City
country: Mexico
facility: National Institute of Respiratory Diseases
Study officials:
affiliation: Centro Medico ABC
name: Antonio Camiro Zúñiga, MD
role: PRINCIPAL_INVESTIGATOR
References: