Micro RNA as Prediction and/or Prognostic Markers of IRIS in TB-HIV Co-infected Patients

HIV Infection Clinical Trial

— miRNA  

Official title:

Micro RNA as Prediction and/or Prognostic Markers of IRIS in TB-HIV Co-infected Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03941210
• Other study ID #: ANRS 12358
• Status: Recruiting
• Start date: March 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: January 2020
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: Polidy PEAN, MD, PhD
• Phone: +85512552182
• Email: polidy[@]pasteur-kh.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The role of miRNAs in HIV disease is yet to be completely defined. Host miRNAs target certain HIV genes, thus can affect HIV replication and participate in viral control. miRNAs can also block HIV production through disruption of Gag assembly on cell membranes. miRNA expression can characterize HIV disease phenotype, as has been shown in HIV elite controllers who have a well-defined miRNA expression profile. However, the studies of miRNA in acute infection and co-infections like tuberculosis are lacking. The investigators showed that during immune reconstitution syndrome (IRIS) in HIV/TB coinfected patients, innate immune response play a role as through NK cell degranulation, therefore testing for this could be used as a predictive marker of IRIS.

One of the limitations of miRNA detection is the technique, which is time-consuming, and needs laboratories that are specialized and equipped for molecular biology techniques. In contrast, flow cytometry has been developed in routine labs and has well-standardized techniques. For the routine detection of miRNA, flow cytometry could be the best way to perform high throughput screening for clinical applications.

Flow cytometry is a simple and effective way to evaluate miRNAs expression. In this project the investigators propose to evaluate, using flow cytometry, whether circulating miRNA pattern might be applicable as potential biomarkers in prediction and prognosis of IRIS in HIV/TB co-infected patients. The investigators propose to study the miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolution. As controls, the investigators propose to analyze expression of miRNAs in healthy controls as well as TB and HIV mono-infected patients.

AIMS OF THE PROPOSAL

1. Identify miRNA expression profile as potential novel predictive and prognostic biomarkers for IRIS.

2. Identify the miRNA expression profile in HIV patients, in TB patients and in HIV/TB co-infected patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

For HIV+/TB+ participants:

Inclusion Criteria

• cf the CAMELIA clinical trial (NCT00226434)

Exclusion Criteria:

• cf the CAMELIA clinical trial (NCT00226434)

For HIV+/TB- participants:

Inclusion Criteria

• Age = 18 years

• HIV+

• CD4 cell count = 200 x 106 cells/l

• No evidence of tuberculosis infection.

Exclusion Criteria:

• Age <18 years

• Pregnancy or breastfeeding

• CD4 cell count > 200 x 106 cells/l

• Evidence of tuberculosis infection

• Non ART naive at inclusion

For HIV-/TB+ participants:

Inclusion Criteria

• Age = 18 years

• HIV-

• Confirmed tuberculosis infection.

Exclusion Criteria:

• Age <18 years

• Pregnancy or breastfeeding

• AFB negative or MTB/RIF negative for MTB,

• History of TB infection

• HIV+

For HIV-/TB- participants:

Inclusion Criteria

• Age = 18 years

• HIV-

• No evidence of tuberculosis infection.

Exclusion Criteria:

• Age <18 years

• Pregnancy or breastfeeding

• Evidence of tuberculosis infection

• HIV+

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infection
• Infection
• Latent Tuberculosis
• Tuberculosis
• Tuberculosis Infection

Intervention

Other:
• Detection of molecular Biomarkers
MicroRNA expression profile analysis by flow cytometry

Locations

Country	Name	City	State
Cambodia	Institut Pasteur du Cambodge	Phnom Penh

Sponsors (1)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Country where clinical trial is conducted

Cambodia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolution	Evaluate, using flow cytometry, whether circulating miRNA (in plasma and/or exosomes) pattern might be applicable as potential biomarkers in prediction and prognosis of IRIS in HIV/TB co-infected patients.; Description of miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolution.	March 1st 2018 - March 1st 2020