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

Last updated: January 6, 2020
Sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv/aids

Aids And Aids Related Infections

Hiv

Treatment

N/A

Clinical Study ID

NCT03941210
ANRS 12358
  • Ages 18-100
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

For HIV+/TB+ participants: Inclusion Criteria

  • cf the CAMELIA clinical trial (NCT00226434)

Exclusion

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+

Study Design

Total Participants: 134
Study Start date:
March 01, 2018
Estimated Completion Date:
March 01, 2020

Connect with a study center

  • Institut Pasteur du Cambodge

    Phnom Penh,
    Cambodia

    Active - Recruiting

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