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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

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

Clinicaltrials.gov identifier NCT03941210

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted January 7, 2020

Study Description

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:HIV Infection
    Tuberculosis Infection
  • Intervention/Treatment: Other: Detection of molecular Biomarkers
  • Phase: N/A
Detailed Description

N/A

Study Design
  • 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 2018
  • Estimated Primary Completion Date: March 2020
  • Estimated Study Completion Date: March 2020
Groups and Cohorts
Groups/Cohorts 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
  • 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
  • Ages Eligible for Study: 18 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 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
Contacts

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

Locations

Cambodia
Institut Pasteur du Cambodge
Phnom Penh

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
  • 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 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by 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: Infection
    Communicable Diseases
    Tuberculosis
    Latent Tuberculosis