Lowering InterLeukin-1 Receptor Antagonist Concentrations After TB Treatment Onset (LILAC-TB)

ANRS, Emerging Infectious Diseases

Status: Unknown

Conditions: Tuberculosis

Study type: Observational

Funder types: Other

Identifiers

NCT04015713

ANRS 12394 LILAC-TB

Details and patient eligibility

About

Despite marked improvements in the diagnosis of tuberculosis there are difficulties in diagnosing and monitoring treatment outcome among TB patients. The use of immunological biomarkers alone or in combination with other clinical parameters could predict early the response to TB treatment. The aim of this study is to demonstrate that the IL-1 receptor antagonist (IL-1Ra) concentrations significantly decrease within two weeks following TB treatment initiation in adults with active documented TB.

Full description

The HIV/AIDS epidemic and Tuberculosis (TB) remain important challenges for global public health and are strongly linked. Despite marked improvements in the diagnosis of tuberculosis, there are difficulties in diagnosing and monitoring treatment outcome among TB patients. The use of immunological biomarkers alone or in combination with other clinical parameters could better predict the response to TB treatment. The aim of this study is to demonstrate that the IL-1 receptor antagonist (IL-1Ra) concentrations significantly decrease within two weeks following TB treatment initiation in adults with active documented TB. This is a proof-of-concept study, among 100 patients (50 HIV positive and 50 HIV negative) with documented active TB, in Cambodge and Côte d'Ivoire. Patients recruited for this study will receive the standard TB treatment per their respective national treatment guidelines. Plasma samples will be collected at baseline (initiation of TB treatment), weeks 1, 2, 4 and 8 to measure IL-1Ra, sCD163 and IP-10.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years

• Evidence of TB, with: positive Xpert MTB/RIF

• For HIV infected patients:

  • ART-naïve
  • Regardless of CD4 cell counts

• Written informed consent

• Willingness to be followed up in the study clinics for 6 months after inclusion

Exclusion criteria

• Mycobacterium tuberculosis strain resistant to rifampin with Xpert MTB/RIF
• Ongoing TB treatment
• Overt evidence of other ongoing opportunistic infections
• Pregnant or breastfeeding women
• Karnofsky score ≤ 30
• Person unable to understand the study
• Person currently participating in clinical trial
• Females on oestroprogestative and progestative hormonal contraception

Trial design

100 participants in 2 patient groups

TB HIV-negative

Description:

Patients will receive standard TB treatment and will be followed according to the national procedures. In addition, plasma samples will be collected at baseline, Week 1, Week 2, Week 4 and Week 8 to measure IL-1Ra, sCD163 and IP-10. Baseline will be the initiation of TB treatment. All participants will be followed 24 weeks.

TB HIV-positive

Description:

Patients will receive standard TB treatment and will be followed according to the national procedures. In addition, plasma samples will be collected at baseline, Week 1, Week 2, Week 4 and Week 8 to measure IL-1Ra, sCD163 and IP-10. Baseline will be the initiation of TB treatment. All participants will be followed 24 weeks.