Lowering InterLeukin-1 Receptor Antagonist Concentrations After TB Treatment Onset

Tuberculosis Clinical Trial

— LILAC-TB  

Official title:

LILAC - TB : Lowering InterLeukin-1 Receptor Antagonist Concentrations After TB Treatment Onset : a Proof of Concept Study in Cambodia and Ivory Coast (ANRS 12394)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04015713
• Other study ID #: ANRS 12394 LILAC-TB
• Status: Recruiting
• Start date: January 21, 2020
• Est. completion date: March 2021

Study information

• Verified date: February 2020
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: Laurence Weiss, MD,PhD
• Phone: 33 (1) 56 09 3297
• Email: laurence.weiss[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Locations

Country	Name	City	State
Cambodia	Institut Pasteur Cambodge	Phon Phen
Côte D'Ivoire	CEPREF/Programme PACCI	Abidjan

Sponsors (4)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	European Georges Pompidou Hospital, Institut National de la Santé Et de la Recherche Médicale, France, Institut Pasteur, Cambodia

Countries where clinical trial is conducted

Cambodia,  Côte D'Ivoire, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the plasma concentration of IL-1Ra between baseline (initiation of TB treatment) and Week 2	To measure plasma concentrations of IL - 1Ra among TB patients after two weeks of TB treatment	2 weeks
Secondary	Evolution of the plasma concentration of IL-1Ra between baseline (initation of TB treatment) and weeks 1, 2, 4 and 8	To measure plasma concentrations of IL - 1Ra and assess the evolution of the concentration of IL-1Ra among TB patients at week 1, week 2, week 4 and week 8 after treatment initiation	8 weeks
Secondary	Evolution of the concentration of sCD163 between baseline (initiation of TB treatment) and weeks 1, 2, 4 and 8	To measure plasma concentrations of sCD163 and assess the evolution of the concentration of IL-1Ra among TB patients at week 1, week 2, week 4 and week 8 after treatment initiation	8 weeks
Secondary	Evolution of the plasma concentration of IP-10 between baseline (initiation of TB treatment) and weeks 1, 2, 4 and 8	To measure plasma concentrations of IP-10 and assess the evolution of the concentration of IL-1Ra among TB patients at week 1, week 2, week 4 and week 8 after treatment initiation	8 weeks
Secondary	Impact of the occurrence of events on the evolution of biomarkers from baseline (initiation of TB treatment) to the end of treatment (Week 24)	Impact of the occurrence of the following events/situations on the evolution of biomarkers (IL-1Ra,sCD163 and IP-10) : intercurrent infection, TB-associated immune reconstitution inflammatory syndrome (IRIS), TB treatment outcome, MTb strains resistant to TB drugs.	24 weeks