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

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ClinicalTrials.gov Identifier: NCT03941210
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases ( French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) )

Study Description
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Brief 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.

Condition or disease Intervention/treatment
HIV Infection Tuberculosis Infection Other: Detection of molecular Biomarkers

Study Design
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Study Type : Observational
Estimated Enrollment : 134 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Micro RNA as Prediction and/or Prognostic Markers of IRIS in TB-HIV Co-infected Patients
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

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Groups and Cohorts
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Group/Cohort Intervention/treatment
HIV+/TB+

Frozen samples and data from participants recruited in the ANRS 12095 CAMELIA clinical trial and the ANRS 12153 CAPRI NK study will be used for this study arm

All plasma samples were collected before any treatment during IRIS diagnosis and at W8 post TB treatment initiation

 Other: Detection of molecular Biomarkers
MicroRNA expression profile analysis by flow cytometry
HIV+/TB-

Participants included in this study arm will be HIV+ and TB-

One time collection of 5 ml of blood will be drawn in EDTA tube for each patient before starting cART and sent to the laboratory for protocol analysis

 Other: Detection of molecular Biomarkers
MicroRNA expression profile analysis by flow cytometry
HIV-/TB+

Participants included in this study arm will be HIV- and TB+

Collection of 5 ml of blood drawing in EDTA tube will be requested for each patient before starting TB drug treatment and after week 2 and 8 of treatment

 Other: Detection of molecular Biomarkers
MicroRNA expression profile analysis by flow cytometry
HIV-/TB-

Participants included in this study arm will be HIV- and TB-

Clinical examination to rule out overt evidence of TB and, whenever needed, routine TB testing as per national guidelines (sputum smear ± chest X-ray) in case of symptoms/clinical manifestations suggestive of TB.

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


Outcome Measures
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Primary Outcome Measures :
  1. miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolution [ Time Frame: March 1st 2018 - March 1st 2020 ]

    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.



Biospecimen Retention:   Samples With DNA
Plasma/cells samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. 74 TB - HIV co-infected patients (37 TB-IRIS and 37 non TB-IRIS) whose plasma were stored during the ANRS 12095 CAMELIA clinical trial (NCT00226434) and ANRS 12153 CAPRI NK study will be included in the study.
  2. 20 HIV ART naïve patients will be enrolled in Sihanouk Hospital Center of HOPE in Cambodia.
  3. 20 newly active tuberculosis patients will be enrolled in Sihanouk Hospital Center of HOPE in Cambodia.
  4. 20 healthy individuals will be recruited from the patients coming to Pasteur Institute in Cambodia for pre-marital test for HIV and who agree to participate in the study.
Criteria

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+
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941210


Contacts
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Contact: Polidy PEAN, MD, PhD +85512552182 polidy@pasteur-kh.org

Locations
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Cambodia
Institut Pasteur du Cambodge Recruiting
Phnom Penh, Cambodia
Contact: Polidy PEAN, MD, PhD    +85512552182    polidy@pasteur-kh.org   
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
More Information
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Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT03941210    
Other Study ID Numbers: ANRS 12358
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ANRS, Emerging Infectious Diseases ( French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ):
microRNA
HIV
Tuberculosis
IRIS
Biomarkers
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Tuberculosis
Latent Tuberculosis
 Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections