Lowering Interleukin-1 Receptor Antagonist Concentrations After the Start of TB Treatment: A Proof-of-Concept Study in Cambodia and Côte d'Ivoire
The HIV/AIDS and tuberculosis (TB) epidemics remain major global public health challenges and are closely linked. The high number of deaths from undiagnosed tuberculosis among patients who died of AIDS in Africa may indicate that tuberculosis is an underestimated cause …
Project Details
Principal Investigator
Alexandra Bitty-Anderson
Duration
29 months
Sponsor
ANRS
Objectives
Main Objectives
Secondary Objectives
Secondary Objective 1: To evaluate the kinetics of IL-1ra reduction, as well as two other biomarkers (sCD163 and IP-10), during two months of antituberculosis treatment in HIV-positive and HIV-negative
patients Secondary Objective 2: To evaluate the impact of the frequency of the following events on biomarker trends: intercurrent infection, Immune Reconstitution Inflammatory Syndrome (IRIS), resistance to Mycobacterium tuberculosis, and the outcome of antituberculosis treatment
Description & Context
The HIV/AIDS and tuberculosis (TB) epidemics remain major global public health challenges and are closely linked. The high number of deaths from undiagnosed tuberculosis among patients who died of AIDS in Africa may indicate that tuberculosis is an underestimated cause of death among people living with HIV. Despite marked improvements in tuberculosis diagnosis, challenges remain in diagnosing and monitoring tuberculosis due to the reliability of the tools used and within the context of empirical tuberculosis treatment, especially among HIV-positive patients. The use of immunological biomarkers, either alone or in combination with other clinical parameters, to predict response to antituberculosis treatment at an early stage could be beneficial for clinicians.
Method
: A conceptual study will be conducted involving 100 adults (60 HIV-positive and 40 HIV-negative). Patients recruited for the study will receive the standard tuberculosis treatment currently in use in their respective countries. Blood samples will be collected at the start of TB treatment and then at weeks 1, 2, 4, 8, and 24 to measure the biomarkers IL-1Ra, sCD163, and IP-10.
Expected Results
- To determine whether variations in the concentration of the IL -1Ra (and the other biomarkers sCD163 and IP-10) during the first 8 weeks of antituberculosis treatment could serve as a reliable and effective tool for predicting the efficacy of antituberculosis treatment in both HIV-positive and HIV-negative patients.
Study Criteria
Inclusion
Inclusion criterion 1: Be 18 years of age or older
Inclusion criterion 2: Positive
GeneXpert MTB/RIF tuberculosis test Inclusion criterion 3: For HIV-positive patients, be antiretroviral-naïve
Exclusion
Exclusion criterion 1: Evidence of rifampin-resistant
Mycobacterium tuberculosis strains Exclusion criterion 2: Evidence of an active
opportunistic infection Exclusion criterion 3: Current
pregnancy or breastfeeding Exclusion criterion 4: Karnofsky score ≤ 30
Research Team
The research team has not yet been filled in for this project.
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